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Participating in CCSVI clinical trials
Several options are now available for patients interested in participating in a CCSVI clinical trial. Participating in a clinical trial helps ensure that you receive safe and humane testing and treatment. Further, participating in clinical trials advances the CCSVI cause for others, allowing researchers to better understand and improve CCSVI technologies and treatment. Please note: information on this page applies only to CCSVI Clinical Trials in the United States.
How Clinical Trials Help Ensure Your Safety Generally, clinical trials are scientific studies that have been reviewed and approved by an advisory panel called an “Institutional Review Board,” or “IRB.” While different types of IRBs have slightly different procedures and responsibilities, all IRBs are designed to ensure that clinical trials are run in a manner that ensures the ethical and humane treatment of all human subjects. IRB approved clinical trials generally fall into two types:
NIH registered clinical trials must conform to an extensive set of regulations and guidelines covering most aspects of the trial, including the ethical treatment of human subjects, use of appropriate scientific methodologies, trial sponsorship, and availability of trial outcome data. Details of these regulations can be found at the Health and Human Services Office of Human Research Protections. Virtually all educational institutions and hospitals have an IRB designed to review and monitor clinical trials. Educational and hospital sponsored clinical trials may or may not be registered with the NIH, but, because these institutions have experienced IRBs, patients have some assurance that ethical and humane practices are being followed. Educational institutions and hospitals often adopt some or many NIH guidelines on ethical treatment of human subjects. Moreover, educational institutions and hospitals often either post their IRB practices on-line or make them available upon request. While IRB approval cannot guarantee absolute patient safety (nothing can) during clinical trials, IRB approved trials are nonetheless far preferable to treatment in facilities that have undergone no independent review at all.
IRB approved CCSVI clinical trials may be designed to test and validate (or invalidate) all aspects of CCSVI, including diagnosis, theory, or treatment. Results from IRB approved trials are eligible to be posted in the NIH database of trial results, which is available to the public and to other researchers1 The publication of scientifically valid CCSVI clinical trial data is essential to scientists and physicians looking to understand and improve CCSVI diagnosis and treatment. Without this data, CCSVI investigation may become fragmented and non-standard, and the results of CCSVI treatments will remain uncertain.
Clinical Trials Currently Seeking Participants CCSVI Alliance understands the urgent need some patients have for receiving immediate CCSVI testing and treatment. However, for the reasons cited above, we encourage patients to get tested and (if necessary) treated in a clinical trial setting whenever possible. Currently available clinical trials include:
Clinical Trials Currently Underway The following IRB approved clinical trials are no longer actively recruiting. However, prospective patients or researchers may wish to contact these organizations to learn more about the current state of the trial or the trial protocols.
Footnotes 1. Most NIH registered clinical trials are required to post results data; IRB-approved but non-NIH registered trials still have the opportunity to post results though they may not be required to do so; non-IRB approved experiments cannot post in the NIH database). |