CCSVI Alliance recommends that patients seeking testing and treatment for CCSVI participate in IRB approved 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:
- National Institute of Health (NIH) Registered Trials
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.
- Clinical Trials Sponsored by Educational Institutions and Hospitals
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.
How Clinical Trials Advance CCSVI for Others
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.
For more information on clinical trials in the US, please visit:
http://www.ccsvi.org/index.php/helping-the-cause/clinical-trials-in-the-us
