Jump to content
helplinedonate
  • Announcements

    • ForumAdmin

      Frequently Asked Questions - Step by step guides

      Do you need assistance registering, logging in, posting, etc? Please visit the all new Frequently Asked Question Forum for step-by-step guides. Click the link below to access these helpful guides. Frequently Asked Questions
    • ForumAdmin

      Recursos Nuevos en Español

      http://www.parkinson.org/ayuda   http://www.parkinson.org/espanol    
    • ForumAdmin

      Línea de Ayuda 1-800-473-4636

      Línea de Ayuda 1-800-473-4636   ¿Qué es la línea de ayuda 1-800-4PD-INFO (473-4636) de la Fundación Nacional de Parkinson? Es un número de teléfono gratuito que ayuda a las personas con la enfermedad de Parkinson, sus familiares, amigos y profesionales de salud, a solucionar diferentes inquietudes.   La línea de ayuda ofrece: Información actualizada Apoyo emocional Referidos a profesionales de salud Recursos comunitarios Amplia variedad de publicaciones gratis    

Search the Community

Showing results for tags 'research'.



More search options

  • Search By Tags

    Type tags separated by commas.
  • Search By Author

Content Type


Forums

  • Forum Information
    • Discussion Corner Announcements
    • PF Forum Member Service Center
    • Frequently Asked Questions - How Do I...???
  • Medical Questions
    • Ask The Doctor
    • Ask The Surgical Team
    • Ask about Nutrition
    • Ask the Pharmacist
    • Pregúntele al Médico
    • Talk To A Speech Clinician
  • Unmoderated Discussion
    • Open Forum
    • Newly Diagnosed
    • Caregivers Forum
    • Young Onset Forum
    • DBS Forum

Found 26 results

  1. Nilotinib trial recruiting

    https://foxtrialfinder.michaeljfox.org/trial/4999/ Phase IIa trial of Nilotinib is recruiting at a number of locations. This is the leukemia drug that caused quite a bit of excitement a year or two ago. My MDS is one of the study doctors. I don't qualify, as it appears this trial requires patients to be on levadopa at least 30 days prior, but others here might be interested.
  2. Science does'nt share

    https://ca.news.yahoo.com/weve-deceived-many-clinical-trial-220000796.html 'We've been deceived': Many clinical trial results are never published CBC November 24, 2016 Every year, thousands of Canadians sign up to participate in clinical trials, offering their bodies to further the development of important medical advances like new drugs or devices. But the results of many of those trials never see the light of day. A new online tool aims to put pressure on some of the companies and institutions behind the problem. TrialsTracker maintains a list of all the trials registered on the world's leading clinical trials database and tracks how many of them are updated with results. Amid pharmaceutical companies and research bodies from around the world on ClinicalTrials.gov, maintained by the U.S. National Institutes of Health, nine Canadian universities and institutions rank in the top 100 organizations with the greatest proportion of registered trials without results. "It's well documented that academic trialists routinely fail to share results," says Ben Goldacre, who was part of the team from the University of Oxford that developed TrialsTracker. "Often they think, misguidedly, that a 'negative' result is uninteresting — when, in fact, it is extremely useful." The University of Toronto's David Henry says "publication bias," as it's called, is robbing the medical community and patients of important information. "We've been deceived about the truth about treatments that we've used widely over a long period, in very large numbers of individuals, because of the selective publication of results that are favourable to the product," says Henry, a professor of health systems data at U of T's Institute for Health Policy Management and Evaluation. But Henry adds that publication bias isn't the only reason results aren't being made public. He says many institutions haven't made it a priority. "If you leave it to the trialists, they've often moved on to the next trial," he says. "At the end of the day, I don't think they give enough weight to it." Increasing transparency Henry notes there has been progress as the scientific community begins to recognize the importance of making all results available. The U.S. Food and Drug Administration (FDA) now requires most clinical trials to register and post results on ClinicalTrials.gov. But studies show many organizations are ignoring the rules. In a paper that accompanied the launch of TrialsTracker earlier this month, Goldacre noted that approximately half of registered clinical trials fail to publish their results, and studies with negative or non-significant results are twice as likely to be unpublished. TrialsTracker's real-time data supports these findings. An algorithm scours for results within ClinicalTrials.gov and also among the available scientific literature. Using this method, the researchers found that between 2006 and 2014, 45 per cent of the clinical trials registered on ClinicalTrials.gov — or nearly 12,000 studies — are missing results. Both the University of British Columbia and University Health Network — the two Canadian institutions with the highest number of missing results on TrialsTracker — point out, in statements sent to CBC News, that the site's algorithm will miss some results. Goldacre acknowledges the method isn't perfect, but says trialists must take responsibility for ensuring results are easily accessible. "Research that is hard to discover is not transparently reported," he writes. Both institutions said they continue to work on ways to ensure that research participants are better informed about the results of studies they participate in. Publications officers One possible solution might be found at the Ottawa Hospital Research Institute (OHRI), where the organization's first "publications officer" was hired about a year ago, to help researchers navigate the often daunting process of publishing their results. David Moher runs the Centre for Journalology at OHRI, which studies the science of academic publication. He advocated for hiring the publications officer, and says part of their job is to explain there are more ways to publish results than in traditional academic journals. "The important point is to make results available, and there are many ways to do that in 2016," he said, pointing to the open-access repositories that are available at several Canadian universities as an example. Moher hopes to study the effect of the publication officer at his institution and, if it's effective, see the model replicated at institutions across the country.
  3. Hi - I was happy to hear this report on my way to work. The upshot: animal studies haven't been working for Parkinson's & other neuro diseases. Mini brains provide a way for researchers to experiment on human 'brains'. http://www.npr.org/sections/health-shots/2016/11/13/501257433/minibrains-could-help-drug-discovery-for-zika-and-for-alzheimers cheers
  4. Questions on your experiences

    Hi everyone, My name is Alex and I'm an industrial design student at University of Cincinnati. Currently I'm trying to design a walker for people suffering from Parkinson's, after seeing how difficult movement is for a friend of mine who has the disease. I know it is a sensitive topic and I don't want to tread on anyone's toes, but your input is invaluable as a patient or caretaker who deals with Parkinson's everyday. The last thing I want is to make something useless out of naivety or lack of comprehensive forethought. I know everyone has different a different experience with the disease and I'd like to account for the different ways it may affect you. I have a number of questions, and I hope have a conversation about them with you rather than offer a survey for you to complete. I'll try not to write a wall of text while explaining every one of my questions, but I think a bit of context might help. If you're interested in more background I'll gladly provide additional information. One area I'm looking at is staircases. My friend (whom I'll call George out of respect for his privacy) uses multiple walkers, because he can't take them up and down stairs. One idea I have is to make a lightweight walker that can help him move up and down stairs with greater ease. However, I also realize how devastating a fall can be if it were to happen. What are your experiences on staircases? Do you require a handrail? If so, how do you use it? (One or both hands, for balance, weight support, etc?) Would you be interested in a walker that can go on stairs at all, or would such an idea be too risky to use in a real world situation? Another area I've looked at is freezing. There are some mobility devices out there that have laser guides or small sticks that you can step over, which reportedly help rewire the thought process behind taking a step so that freezing can be counteracted. Similarly, I've read that walking on patterned tiles (checkerboard or white and black stripes for example) can help make walking smoother. Do you have any thoughts on this, in terms of your own experiences with freezing, personal remedies, and opinions on such technologies/practices? My last focus is on the adjustability of walkers. If you have a folding walker, how often do you fold it up and for what purpose? Most walkers can be adjusted for height, but do you ever wish it could be more easily changed? For example, for people who have difficulty getting out of a chair, do you ever wish your walker was a different height to help with standing up? I sincerely hope not to insult anyone with these questions. Any answers at all would be greatly appreciated, and of course only answer what you are comfortable talking about. If you have any advice for me in terms of approaching the topic in the future, please do let me know. Thank you for all your help! Regards, Alex
  5. Need research and testers for a PD app

    Hello! I am a US high school student looking for some help. I developed an Android app for Parkinson's research (and a little bit of user record keeping also). It is nowhere near perfect, but I would greatly appreciate any use of the app. Whether you have Parkinson’s disease or not, simply taking less than five minutes out of your day to do a measurement and or survey would give us a lot of data that we desperately need in order to make conclusions on our research. Ultimately, the goal is to use machine learning algorithms to help in the diagnosis of Parkinson’s and to simply get more information about the disease overall. Again, taking five minutes out of your day to install, test drive, and contribute to research on the app at https://play.google.com/store/apps/details?id=com.buckley.robert.parkinsonszero&hl=enwould make a huge difference. Why not take part?
  6. Hello, I am studying design and technology in year 11 at Catherine McAuley High School and am currently designing a product to enable those who are diagnosed with Parkinson's Disease to live a more independent life. My main focus is on designing a tool which makes the everyday task of hanging out the laundry much easier. The following questions are part of my research in order for the design to suit personal needs and be successful in improving the lives of those who suffer from Parkinson's. Any questions that you don't feel comfortable completing can be left blank. https://www.surveymonkey.com/r/X8BHVC5 If there are any problems or queries feel free to message me x
  7. Hello, I am studying design and technology in year 11 at Catherine McAuley High School and am currently designing a product to enable those who are diagnosed with Parkinson's Disease to live a more independent life. My main focus is on designing a tool which makes the everyday task of hanging out the laundry much easier. The following questions are part of my research in order for the design to suit personal needs and be successful in improving the lives of those who suffer from Parkinson's. Any questions that you don't feel comfortable completing can be left blank. Click here to complete the survey. Thank you for helping in the process of allowing those diagnosed with Parkinson's to become more independent.
  8. I am a 68 yo male in good health with the exception of PD. My diagnosis was in June, 2014. I am on a Dopamine Agonist and MAO-B Inhibitor only. Last evening I was sent a questionnaire by MJFF regarding my level of interest in participating in a Vanderbilt Research Project intended to determine if early after diagnosis, DBS is effective in slowing the disease progression among other things. My interest level is high. However, my question is what is the possible downside of participating other than the normal risks associated with DBS? BTW, last year I was at the White House when Dr. Okun received his award. I have read both books and have the last on audio as well as in print.
  9. Hello Caregivers! We are conducting a new 2015 research study about the experiences of caregivers of persons with Parkinson’s disease. Please consider taking the 20 minute survey. Click on the following link for more information. http://mabend.tumblr.com/ Thank you Maryann Abendroth, PhD, RN Northern Illinois University
  10. Help some danish students!

    Hello We are a group of students from Aalborg University (Medialogy), Denmark, who are working on a project about people with hand-related motor impairments, such as Parkinson’s disease, and their usage of smart devices with the intention of improving their accessibility to these technologies. We hope some of you will take a few minutes to complete our survey. Thank you for your time. https://docs.google.com/forms/d/1cxb42zGUqr6LmHeRO1vdjX6jrbS6K-On8Cru4Jl-0Y0/viewform?c=0&w=1
  11. UCSF - Brain Registery

    http://www.brainhealthregistry.org/ Please sign up and encourage family/friends to also join it. The idea of this study is to get 50,000 people of all walks of life..... Sign up, give a little medical history, take some test and go back in three to six months to repeat the test. It will allow researchers a large sample of people to see what commonalities area. Wouldn't it be a mind blower to discover one group who has a acne medications showed zero progression of Parkinsons. Yes, I am making it up but many scientific discovers do start with an observation of "Hmm, that seems odd why does this group of participants..... ". We just don't know enough to know enough! Check out "why it matters".
  12. This topic has been around earlier in research discussions, but it's up again. And the results seem very significant: "A lengthy history of continuous smoking reduces the risk 36-50 percent and drinking coffee regularly another 33 percent. The exact cause behind the phenomena is unknown at this point." Read more here: Finnish study: Smoking and drinking coffee might prevent Parkinson's disease What is your take on this?
  13. Happy new year to all! You're favorite pharmacist is back for another year behind the intergalactic pharmacy bench and is ready to answer you're questions. First off, I would like to clean up some old business. A friend of mine from across the pond, Miss Lisa Vanderberg, sent me this Public Service announcement that has been circulating around. I have seen it, I like it, it is to the point, and it is true. I hate to say this but, many of the donors that put money into the NPF, or other Parkinson's organizations, are people who either have PD or know someone who has PD. My challenge is simple. So simple it hurts that I did not think of it earlier. How many people heard about the girl who sold Girl Scout Cookies outside of a legal medical marijuana dispensary? Was that a no brainer or what. Now, I am neither condemning nor condoning the use of marijuana, what I am doing is applauding the entrepreneurial skills of this girl. BRAVO! Now we, meaning us with Parkinson's, are kind of tired of chipping into our own till all the time to help "us." If you think of it, we already are putting our money in the till. We pay for Dr visits to a Parkinson's Dr, we pay for Parkinson's medication, we pay for things to help us around the house (canes, lift chairs, special beds, holders for the bath tub, etc). My challenge is this: I would like for everyone out there who belongs to a non-Parkinson's organization, to get just 1 person to donate $1 to the NPF. This way we are going outside of our group to get help for us and for you. Below is the link to the service announcement. Please, copy and paste it and send it to the other organizations you are in, you can even include it with you're emails, or if you know someone who owns a company, have them put this on their outgoing email. I know we can do this. We are off to battle Parkinson's Disease, and I would bring everyone of you with me. Why? Because you are strong, you persevere, you are head strong, and you are fighters. The best part is, we do it every day of our life. In fact while I was writing this, my insurance agent called, and I figured I would throw it by him. I figure, I give him money, the least he can do is donate $1. I walked him through the steps to get to site and where to donate, and BANG....we just got $10 bucks. It's time to fight for us, so copy this link below, and feel free to pass along you're success stories. Heck, pass along any story that worked. Let's get it on people! The challenge starts now, and does not stop. Good luck! https://www.linkedin.com/pulse/we-forgotten-patients-lisa-vanderburg
  14. Hello! I am a senior product design student from University of Illinois, and as a part of my thesis project, I am working on redesigning a bedpan. Both my parents are doctors, and thus I have seen the vast number of problems patients as well as caregivers face while using the bedpan. It is a product that almost everyone uses at least once in their lifetimes, but has never been improved because of the stigma attached to it. I was going through the different threads on this forum, and it pains me to see the problems people face. I would love to be able to help in my small way by making a better product and making a difference in someone's life. Please let me know if you or someone you know has used a bedpan, and would like to start a conversation. I would love your insights on the various difficulties people face while using bedpans, and how you worked your way around them. My email address is jasani2@illinois.edu Lets make a difference together.
  15. http://www.thestar.com/news/canada/2014/09/16/drugtesting_rules_broken_by_canadian_researchers.html Drug-testing rules broken by Canadian researchers Top Canadian doctors running clinical trials have risked patient safety, failed to report serious side-effects suffered by their human test subjects and botched the scientific research of the drug By: Jesse McLean Investigative News reporter, David Bruser News Reporter, Staff Reporters, Published on Tue Sep 16 2014 The doctors, some of them esteemed researchers from Canada’s most prestigious hospitals and academic institutions, have also routinely broken rules designed to protect participants and botched research of new treatments. Using records obtained through U.S. freedom of information legislation, a Star investigation has found the following problems in the system designed to ensure new drugs are safe and effec In 2012, a top Toronto cancer researcher failed to report a respiratory tract infection, severe vomiting and other adverse events. A clinical trial run by an Alberta doctor reported that patients responded more favourably to the treatment than they actually did. A Toronto hospital’s chief of medical staff ran a clinical trial of autistic children on a powerful antipsychotic, and he did not report side-effects suffered by four of the children. And numerous doctors across the country failed to tell participants that one of the goals of the clinical trial was to test the safety of the drug they were taking. Health Canada inspects a small number of the 4,000 drug trials running at any one time across the country. The inspection results are kept secret. But the Star was able to learn about problems with some of the trials through records from the U.S. Food and Drug Administration. This is because the experiments, run by Canadian doctors and involving Canadian test subjects, were used to see if a drug was safe for the U.S. market and were therefore open to inspection by the FDA. Many of the drugs have also been approved in Canada. The FDA makes inspection dates and results available to the public on its website. When the Star sought additional details of the violations American inspectors found in Canada, the FDA provided the records with little delay. The FDA inspection reports on Canadian trials show shoddy and sometimes risky work performed by Canadian doctors, some of whom have accepted money from the same drug companies sponsoring the trials. The U.S. inspectors’ findings suggest pervasive problems in Canadian clinical trials: The FDA found objectionable conditions in more than 60 per cent of the 192 study sites they have visited since 1981. At least eight Canadian doctors are repeat offenders, including an Alberta cancer researcher, Dr. Alexander Paterson, whose work has been flagged for problems in three separate FDA inspections. Clinical trials are experiments using volunteer subjects to determine whether a drug is safe and effective, as well as what side-effects it may cause. Participants may experience side-effects, which the doctors leading the trials must report. “That data is going to support whether a new drug is safe,” said Tamika Cathey, a former FDA agent whose tasks included inspecting clinical trials. “If there are additional adverse events, and the clinical investigator does not document and notify the (drug company), it could in the end put the patient at risk if the product is submitted and cleared for approval. That’s the bottom line. That’s why it’s critical.” The Star found at least 18 Canadian doctors did not report all adverse events suffered during their clinical trials. STEPHANIE LAKE Dr. Sunil Verma of Toronto's Sunnybrook Hospital was cited by a U.S. health inspector for failing to report adverse reactions suffered by five patients in a drug trial. Verma said it was due to an oversight by his nurse. In late October 2012, a U.S. agent arrived at Toronto’s Sunnybrook Health Sciences Centre to inspect a clinical trial run by Dr. Sunil Verma, chair of breast medical oncology at Sunnybrook’s Odette Cancer Centre. A Swiss drug company that funded the experiment was using the study to get the U.S. regulator to approve the drug, T-DM1, which had shown success in targeting cancer cells and a lower rate of severe side-effects compared to other treatments. The inspector found problems with Verma’s study: He failed to report to the sponsoring drug company adverse reactions suffered by five patients, including a respiratory tract infection and severe vomiting that lasted two weeks. Doctors running the clinical trials are obligated to report side-effects to the experiment’s sponsor, often drug companies, who must include the information in their application to regulators for drug approval. In an interview with the Star, Verma said all the adverse events were recorded during the trial, but “a very small proportion of it” was not input into an electronic database supposed to hold all the side-effect data. He said it was a staff member’s fault. “This was purely a clerical issue. This was clearly an oversight on the part of the nurse,” Verma said. The FDA inspector also found the clinical trial staff discarded original medical observation notes after the information was transcribed elsewhere, which made it impossible “to verify the validity and integrity of data captured at your site.” Verma said all the problems were fixed during the inspection.The FDA later sent a letter acknowledging Verma’s assurancesthat measures were put in place to ensure similar “objectionable conditions” do not occur in future trials. “We are very proud of the great clinical research we do here,” Verma said. “At no point did the patients’ care get affected, at no point did the overall conduct of the trial get affected and at no point was there an intentional purpose by our clinical trial staff to purposely not enter information.” Verma conducted the trial for the company, Hoffmann-La Roche. The doctor said he was not paid by the company for his work on the trial, something that he said would be unethical, but that he is on the firm’s advisory board. When asked about this type of work, he said that from time to time he gets paid to give an “educational presentation” on breast cancer — a day’s work that brings him around $1,500. A Hoffman-La Roche spokesperson said the company’s work with doctors running clinical trials “is not dictated by any speaking engagements the . . . physicians may undertake.” The FDA approved the drug, branded Kadcyla, in February 2013, and Health Canada followed with its approval later that year. Health Canada said it did not inspect this trial but provided few other details of its inspection program. Health Canada only began its trial inspection program in 2002, and the data the regulator makes available shows it has not met its goal of inspecting 2 per cent of the country’s trials each year. A 2011 auditor general report found when the regulator does find problems, it takes as many as 142 days to inform the study leaders of the deficiencies. Health Canada reports on inspection findings that have been published but, unlike FDA records, they do not identify the drugs, the doctors running the trials, or the name of the drug companies. Health Canada told the Star that “confidential and/or proprietary information is removed” from the summary reports. Over the past 12 years, Health Canada found at least 33 clinical trials had critical problems and were “non-compliant.” In July, the Star asked for details of these and other inspections, and last week Health Canada refused, saying that providing records “would require an exhaustive manual paper file review.” The regulator also said the release of these clinical trial inspection reports could only come after consultation with third parties, typically the doctors and drug companies. The Canadian regulator refused to say how many clinical trials it has shut down or stopped, if any. At Toronto’s Scarborough Hospital in the early 2000s, Dr. Atilla Turgay was studying the use of an antipsychotic called risperidone to treat children with autism. Some of the trial subjects were as young as five. Turgay, then the hospital’s chief of medical staff, did not report adverse events suffered by four patients even though the side-effects were “known to be associated with the study drug,” the FDA found. With Health Canada inspecting just a sliver of the country’s clinical trials, much of the responsibility for oversight falls to the drug companies sponsoring the trials, as well as the research and ethics boards. These boards, often set up by the hospital or university where the doctor works, review and approve clinical trial procedures to make sure human subjects are protected. They monitor a trial’s progress and can shut it down if patients are put at unacceptable risk. However, Turgay left the board in the dark for as many as four months about serious reactions that sent two child subjects to the emergency room. In one of these cases, Turgay had to be told to provide parents with information on how to safely give medications after a child was accidentally given 10 times the study dose of a powerful antipsychotic. The child’s tongue swelled, his eyes rolled back and speech faltered. The FDA suggested there was a lapse in oversight by the research board supposedly supervising the experiment. “I knew of (research ethics boards) in the U.S. that would suspend all research of a (clinical investigator) because of his late reporting of (serious adverse events),” the FDA inspector wrote in her 2004 report. “(In this case), it certainly would have been reasonable.” Turgay died in 2010. Hospital spokeswoman Holly-Ann Campbell said no current employees were involved in the study or its oversight and said “we cannot speak to how this situation was managed at that time.” The pharmaceutical company that sponsored the trial refused to say how much it paid Turgay in grants, consulting fees or to give lectures about medical conditions and drug treatments. At the University of Calgary, Dr. Remo Panaccione’s has received money for consulting and lecturing from at least 26 different pharmaceutical companies. Panaccione, a leader in inflammatory bowel disease research who was inspected by the FDA in 2007 and cited for a violation, said it is “necessary” to interact with drug companies to ensure research is beneficial for patients. “With research dollars being harder and harder to get, both researchers and academic institutions need to look at other partnerships to insure we continue to move our respective fields forward,” he told the Star. The number of drug makers that have given him money “demonstrates an involvement across the field and not with one company in particular,” he added. Two studies funded by one of those companies, AbbVie, was the focus of the 2007 FDA inspection. The FDA found Panaccione had not told the university’s ethics board about three test subjects who were hospitalized during a trial studying the use of the drug Humira to treat Crohn’s disease. Panaccione blamed his staff for the “oversight.” He said the hospitalizations were reported to the sponsoring drug company but not the university’s ethics board. He said the hospitalizations were due to a Crohn’s flare-up and not the study drug. An AbbVie spokesperson said, “all clinical trials get audited by regulatory agencies and we fully support and respect this process.” Some Canadian doctors who have been subject to FDA inspections describe the U.S. agents as hard-nosed investigators hell-bent on finding problems. In Alberta, Dr. Alexander Paterson remembers the first time he met an FDA inspector in 1988. “He looked like Dick Tracey with a fedora and a turned-up overcoat. . . . He wouldn’t shake my hand. He produced his ID,” Paterson told the Star. “They’re actually trained detectives and they come up with discrepancies.” Paterson, who works out of Calgary’s Tom Baker Cancer Centre, is a renowned cancer researcher who sits on Health Canada’s advisory panel on oncology treatments. He also holds the dubious distinction of being cited for violations in three FDA inspection reports — in 1988, 2002 and 2004 — more than any other Canadian doctor, according to a Star analysis of available FDA data. The unfavourable report card could be the result of being at the forefront of research into new cancer drugs, he said, which could prompt more FDA inspections than those of the average Canadian researcher. During the first inspection, the FDA inspector uncovered a series of problems with the trial, including one the FDA said was “extremely” concerning: Patient information submitted by the pharmaceutical company to the FDA (to get the drug tamoxifen approved to treat cancer) did not match medical records found in Paterson’s possession. In several cases, the copies given to the regulator suggested the treatment worked better than the doctor’s own progress notes indicated. The inspection also found “possibly ineligible patients being enrolled in the study . . . and patients being incorrectly dosed.” Speaking to the Star, Paterson chalked some of the findings up to an “out-of-his-depth” inspector with no clinical trial experience and who used the most up-to-date standards to grade a study started years earlier. In one case, the inspector’s report says, the record submitted by the drug company said the patient’s response to the treatment involved “no change.” This was in direct conflict with the doctor’s record, which “lists the patient’s response as ‘worse.’ ” The inspector said he found several records at Paterson’s clinic where information was crossed out and changed, “especially in the ‘patient response’ section.” At the time, Paterson and the drug company both denied making the changes. “I certainly don’t think there was any tampering with the data,” Paterson told the Star. “You can never exclude that. (But) I really don’t think that would happen.” He said it was “a good study” that led the FDA to approve the drug “to the benefit of many patients.” The Star found numerous Canadian doctors broke the rules put in place to protect the safety and welfare of clinical trial subjects. Nearly 20 doctors across the country enrolled patients into their studies who should have been excluded, many because of pre-existing health conditions that could make experimental treat\ ments risky.m While researching a new drug for chemotherapy, the Saskatchewan Cancer Agency’s Dr. Muhammad Salim enrolled a patient who should not have been accepted because of uncontrolled hypertension, a 2003 FDA inspection found. Salim did not remove another patient, as required by the study’s rules, when his disease worsened. Salim’s trial also did not report two cases of side-effects, including a gastrointestinal bleed. A spokeswoman for the cancer agency told the Star that Dr. Salim “won’t be made available” for an interview. In one case, a clinical trial by Canadian doctors became the focus of the court. A 2013 lawsuit claimed drug maker Boehringer Ingelheim misrepresented the safety of Pradaxa, a blood thinner that some patients and their families have blamed for causing serious bleeding and death. The lawsuit went after three Hamilton institutions: McMaster University, Hamilton Health Sciences and Population Health Research Institute, a centre jointly operated by the university and the hospital network and that runs clinical trials in Canada and across the world. SCOTT GARDNER After poring over study datasets following a U.S. FDA review of a blood thinner drug, Hamilton's Dr. Stuart Connolly and his team uncovered 81 new adverse events. The institute’s Drs. Stuart Connolly and Salim Yusuf led the sole clinical trial for Pradaxa that played a significant role in the drug being approved in the United States and Canada. The lawsuit alleged the clinical trial failed to report side-effects and produced “tainted data” to get the drug approved. The road to Pradaxa’s approval had been bumpy. The FDA had initially rejected the drug maker’s request to have Pradaxa approved because patient datasets included transcription and auditing errors that “called into question the overall quality of those datasets and (the FDA’s) confidence in them.” Then, in August 2010, U.S. inspectors descended on the research institute and found more deficiencies. Among them, there was no data management plan in place until months after the first of the 18,000 patients were enrolled. “If you do an inspection in a huge study like that . . . there is always going to be some finding. There were some findings, but none of them were considered major,” Connolly told the Star. Spurred by the FDA’s initial rejection, Connolly’s team pored through its datasets. In a 2010 correction to their research article published in the New England Journal of Medicine, Connolly’s team said they uncovered 81 adverse events that were never reported — including a stroke, heart attacks and major hemorrhages — spread across the patients taking either Pradaxa or the medication it was tested against. “In a database with close to a billion data points, there are sometimes going to be errors,” he said. “There were some deficiencies. I totally agree. We had some of the data that wasn’t perfectly accurate on the first filing. There were some events that we found when we went back and took a second look. But those are relatively small issues compared to the clarity and robustness of the initial results.” In May, Boehringer announced it would pay $650 million to settle 4,000 lawsuits against Pradaxa, emphasizing in a press release that it stands firmly behind the safety of the drug. The lawsuit naming the Hamilton institutions is one of them. The institutions told the Star they had no comment as the settlement process “is not complete.” They said they have “complete confidence” in the research.
  16. technology

    Tracking Parkinson’s with Advanced Technologies The Michael J. Fox Foundation is partnering with Intel to develop big data approaches for capturing patients' daily experience of living with Parkinson’s disease. Patients are the greatest experts on their disease. By learning more directly from them about measurable aspects of PD, such as slowness of movement, tremor and gait disturbances, we hope to improve research and treatment of the disease. We are assessing the use of wearable devices, such as smartphones and watches, to track PD 24 hours a day, seven days a week. Intel is developing big data techniques to detect patterns captured by the devices. Those insights could help improve the use of current Parkinson's treatments, assess potential new treatments, and point to new research directions for therapeutic development. What are big data techniques? We think of them as mathematical formulas. By applying these formulas to huge quantities of data — the wearable devices we're testing can transmit up to 300 data points per second per patient — researchers can extract new insights or make predictions. What does this mean for people living with Parkinson’s? For an individual patient, data analysis can give you a better picture of your daily life with PD to share with your doctor, and you can contribute to clinical research by sharing your de-identified data. The technology remains experimental with a small number of volunteers, but eventually we hope wearable devices could become a common aspect of living with PD. How can people with Parkinson's get involved? The next phase of our data gathering study will start recruiting in New York, Boston and Tel Aviv this fall. Register with www.foxtrialfinder.org to be alerted of this and other studies in your area. Want to learn more? Join our Webinar on Thursday, August 21, at 12 p.m. ET to hear from our experts and ask questions.
  17. Today I would like to begin answering this question based on my own personal experiences. I would also like to initiate dialog with people whose lives have been affected by these disorders and people who have actively searched for answers to this question. I became a biophysicist because I wanted to define the magic of life with mathematical models. Finding treatments for diseases was not something I had ever given much serious thought to. Then, within a few years, several eye-opening events took place and changed my views on what was important in my work. Early on, I lost a young colleague to a heart condition. My colleague’s death was a devastating loss not only for me but for everyone who knew him. It was an even more devastating loss for his family, because he was the fourth of five brothers succumbing to the same heart ailment. I, however, was certain that modern medicine had done everything it could do to save my colleague’s life. After all, my colleague had three heart surgeries and several devices implanted. Furthermore, his father was a physician, and I was positive he had uncovered all medical treatments that could save his son’s life. A few years had gone by, and I hadn’t given much thought to my colleague’s heart condition. Then, as I was settling into a new position, preparing my lectures for medical students, I came across some astonishing information. One of the topics I was assigned to cover was channelopathies. Channelopathies are disorders caused by defects in the structure and function of different ion channels. The ion channels are signaling molecules in the cell membrane that allow neighboring cells to communicate with each other. As I was reviewing the scientific literature, I came across studies that had identified my colleague’s heart condition. Had the cardiologists who treated my colleague read the same studies, they would have known that some of the devices they implanted did not benefit my colleague, but rather that they contributed to his death. At this point, I realized that what I do and learn as a biophysicist can translate into effective treatments for some of the most devastating disorders. At the same time, I recognized the presence of the dangerous gap between scientific research and current medicine even when the two target the same medical condition. One cannot help but wonder how many lives are lost in this gap. One thing for sure, I constantly wondered about the toll this gap had on many human lives. Therefore three years ago when we discovered a vast signaling network in the brain that controls motion and cognition, we went into overdrive to characterize this network. We established that current medications that slow the progression of Alzheimer’s disease work through this same network. Furthermore, we found ways to enhance the effects of such medications. Finally, we established that the progression of Parkinson’s disease and the escalation of L-DOPA induced dyskinesia are results of the deterioration of this brain network. However, when I tried to publish the results of our work and make this knowledge available to the entire scientific community, I was stopped by anonymous reviewers of our work. Scientific publishing is a difficult process – every scientist is well aware of this fact. My initial reaction was to provide all additional data requested by the reviewers in order to have our discovery published so that the floodgates of development of new treatments for Alzheimer’s and Parkinson’s diseases would open. Two years later, I realized that our critics would never be satisfied with our data because our work has nothing to do with the established theory of neurodegeneration and formation of amyloid plaques in the brain. In response, I formed Cognistrata Inc. (www.cognistrata.org) with the mission to translate our scientific discovery into new treatments for neurodegenerative disorders. I also decided to turn directly for financial help to the families whose lives are affected by Alzheimer’s disease and other neurodegenerative disorders. In my next blog entry I will explain why no one was able to discover this brain network before we stumbled upon it. But first, I would like to initiate a dialog and hear directly from you. Does it matter to you who will develop effective treatments for Alzheimer’s disease? Would you support a woman biophysicist in her quest to find such treatments? Does it matter to you that most of the work that enabled us to discover the brain network was done in the heart? Or you would rather support the road well-traveled and the $400 million a year money pit focused on amyloid plaques research? I would like to hear your voice and your thoughts publicly or privately (just press the Contact us button at www.cognistrata.org). Thank you. Tatyana Ivanova-Nikolova, Ph.D. Principal Investigator and President of Cognistrata Inc.
  18. If you have not read the positive results they are getting go to the MJFF website and read up - there maybe more coming down the pipe that any of us were aware of. My bet is the doctors and nutritionists will have some links posted tomorrow. Here is what I copied... A vaccine treatment that could slow or stop Parkinson’s disease is moving forward after showing positive Phase I safety trial results. The Michael J. Fox Foundation funded the study and will support the next trial later this year. Parkinson’s Vaccine Safe in Phase I TrialPosted by Maggie McGuire, July 31, 2014 A treatment that could slow or stop Parkinson’s disease today took one step closer to pharmacy shelves. The Austrian biotech AFFiRiS AG announced positive results of its Phase I safety trial of a vaccine against alpha-synuclein. Alpha-synuclein is the sticky protein that clumps in the cells of people with Parkinson’s, and AFFiRiS hopes to stop disease by inducing antibodies against alpha-synuclein accumulation. The Michael J. Fox Foundation funded this work with close to $2M, first with a grant for a pre-clinical study and then $1.5M in 2011 for the Phase I trial. It’s the first drug against alpha-synuclein to reach clinical testing. “A treatment that could slow or stop Parkinson’s progression would be a game changer for the five million worldwide living with this disease and the many more who will become at risk as our population ages,” said MJFF CEO Todd Sherer, PhD. “This trial is one of the most promising efforts toward that goal.” In two different doses the drug, called PD01A, was safe and tolerable. Half of those vaccinated showed alpha-synuclein antibodies, which is a promising but very early sign. Further trials will test PDO1A’s benefit to patients. The next step is a boost study that will test the safety and effect of a boost vaccination (another dose). MJFF will support that trial, which will take place in Vienna, Austria and start recruiting in September. The AFFiRiS trial is one study in the Foundation’s robust alpha-synuclein portfolio. Read more about other ways we’re targeting this protein. Hear more about this study and watch MJFF CEO Todd Sherer, PhD, discuss the potential of an alpha-synuclein therapy at today’s AFFiRiS press conference in New York.
  19. Hello everyone My name is Richard McLernon, a MSc Health Psychology student from the University of Nottingham, and I am looking to invite male members to take part in a piece of important research. My research is focused on the empowering effects of online support group membership on men. Empowerment has been identified as a key component of helping people deal with conditions, illnesses and undertaking drastic health behaviour changes, and several studies have identified that online support groups can play an important part in fostering the sense of empowerment. However, many of these studies have been nearly entirely female based, with male experiences of empowerment in online support groups drastically under researched, especially considering studies have shown that men and women’s help seeking behaviours differ from each other, both face to face and online. This research hopes to start filling in this gap, and create a much better account of empowering processes and the online experience of men in online groups. Who am I looking to take part? Males over the age of 18 and a member of an Online Support Group. What you would do The study would involve you undertaking an asynchronous online interview. What this involves is simply being presented with 8 open ended questions about your experiences with online support groups. The questions can be done in your own time and pace, can be answered with as much detail as you like, you will not ask for any specific details of your health, and should take a maximum of 25 minutes to complete. Benefits of taking part Data from this study could play a great part in understanding the male experience of online support groups. If any evidence of empowerment is encountered, it can be used to help encourage men, who may not usually seek help or support, to join online support groups. If you are a male and wish to take part, or are even just curious, please click the following link, which will take you to an information page, where further details will be provided. https://www.survey.bris.ac.uk/nottingham/male_osg_empowerment Thank you very much for reading. I appreciate that me posting here can be seen as intrusive, and if so I do apologise, and any offense was not intended. Any questions, please feel free to email me at lwxramc@nottingham.ac.uk. Thank you for your time Richard Mclernon
  20. Hello everyone My name is Richard McLernon, a MSc Health Psychology student from the University of Nottingham, and I am looking invite male members to take part in a piece of important research. My research is focused on the empowering effects of online support group membership on men. Empowerment has been identified as a key component of helping people deal with conditions, illnesses and undertaking drastic health behaviour changes, and several studies have identified that online support groups can play an important part in fostering the sense of empowerment. However, many of these studies have been nearly entirely female based, with male experiences of empowerment in online support groups drastically under researched, especially considering studies have shown that men and women’s help seeking behaviours differ from each other, both face to face and online. This research hopes to start filling in this gap, and create a much better account of empowering processes and the online experience of men in online groups. Who am I looking to take part? Males over the age of 18 and a member of an Online Support Group. What you would do The study would involve you undertaking an asynchronous online interview. What this involves is simply being presented with 8 open ended questions about your experiences with online support groups. The questions can be done in your own time and pace, can be answered with as much detail as you like, you will not ask for any specific details of your health, and should take a maximum of 25 minutes to complete. Benefits of taking part Data from this study could play a great part in understanding the male experience of online support groups. If any evidence of empowerment is encountered, it can be used to help encourage men, who may not usually seek help or support, to join online support groups. If you are a male and wish to take part, or are even just curious, please click the following link, which will take you to an information page, where further details will be provided. https://www.survey.bris.ac.uk/nottingham/male_osg_empowerment Thank you very much for reading. I appreciate that me posting here can be seen as intrusive, and if so I do apologise, and any offense was not intended. Any questions, please feel free to email me at lwxramc@nottingham.ac.uk. Thank you for your time Richard Mclernon
  21. Get paid for your opinions!

    WEGO Health is launching a paid Truvio survey for the Parkinson's disease community next week. To see if this is the right fit for your diagnosis experience, please complete this form:http://vclz.co/1ndl7su
  22. My name is Nichole and I'd like to share an opportunity with this community to participate in a paid research study. Participants will be paid $35 for just a 10 minute survey using their smart phone. This study is intended to allow people with Parkinson's disease to give their opinions to health care professionals across the nation. To participate click here: http://vclz.co/1ndl7su If you have any questions about Truvio or this study, please contactsupport@vocalize.co. Thank you. #parkinsons #parkinsonsdisease #healthresearch #truvio
  23. I’m sending this message today because I am a nurse researcher dedicated to helping family caregivers and would like to share information about a research study. The purpose of the study is to explore factors that influence the well-being of caregivers of persons with Parkinson’s disease. The results will help us develop initiatives to assist caregivers. Your input is important because it offers you an opportunity to be heard. You will help people in the health care field understand your caregiving experiences and find better ways to improve services for you and other caregivers. Persons eligible to participate need to be 18 years of age or older and need to be currently or previously a caregiver of a living person with Parkinson’s disease. Anyone interested in being in the study will complete an online survey which will take about 10 minutes. The survey items will include sharing your caregiving experiences (i.e. how you view caregiving) and asking some demographic questions. Your participation is voluntary. All responses will be kept confidential. If you are an informal caregiver of a person with Parkinson’s disease and wish to take part in this study or would like more information, please send an email to me, Dr. Maryann Abendroth, nursing faculty at Northern Illinois University, at mabendroth@niu.edu or call at (815) 753-0812. Participants will receive a $10.00 gift for being in the study.
  24. Dr. Okun, as a scientist actively engaged in research to develop treatments for Parkinson disease, do you believe that the massive funding earmarked for basic research in the BRAIN initiative might divert money away from more treatment-oriented research? It would be easier for me to support the BRAIN initiative if I could be sure that it would not slow down research in areas which might deliver treatments sooner. More basic research is great if it does not starve out translational research.
  25. Hi, my name is Julianne and I am a student at the community college in my town. My final for my Writing 121 class is to write an argument essay and I have chosen to write mine on why there needs to be more funding for Juvenile Parkinsonism. As a JP patient myself it hits close to home. I have a hard time finding forms of treatment that will work for me because of my age and the fact that I am so young. If anyone knows anything or has any references that I could check out to get more information about the research funding that goes into Juvenile Parkinsonism, I would be forever greatful! Because this is such a rare form of PD I have a hard time finding very much information on it and have yet to find anything regarding the amount of money that goes into funding the research so far. Thank you for taking the time to read this and hopefully someone on here will have some ideas! Thank you so much in advance! Take care! - Julianne
×