Clinical Trials Registry
|In September 2004, the International Committee of Medical Journal Editors (ICMJE) stated that "the research enterprise has an obligation to conduct research ethically and report it honestly. Honest reporting begins with revealing the existence of all clinical studies, even those that reflect unfavorably on a research sponsor's product".
The ICMJE instituted rules about registering all clinical trials on a public registry, and indicated that trial results would not be published if not registered (N Engl J Med 2004; 351:1250-1).
New legislation was put in place in the US through the Fair Access to Clinical Trials (FACT) Sec 113 of the FDA Modernization Act which mandated registration of clinical trials through the www.clinicaltrials.gov website for all IND and efficacy trials.
Health Canada has required the registration of trials since 2006 under new legislation entitled "Registration and Disclosure of Clinical Trials Information".
Most recently, the FDA has instituted an amendment to the Act which requires sponsors to expand the types of clinical trials are required to be registered, and to enhance the amount of information submitted to the registry. Additional information now required includes an estimated closure date for each study and the posting of clinical trials results as they become publicly available.
The Canadian Cancer Trials Group has listed all their trials with the Physician Data Query program (PDQ) of the NCI US, which automatically populates the www.clinicaltrials.gov. We supply PDQ with protocol information as well as centre participation on a routine basis, and update this information on an ongoing basis.
For each trial registered, PDQ supplies an "NCT Number". This number is entered into our trials database, and is published on the Canadian Cancer Trials Group for any site who might require this number, particularly for submission to their REB. Look under "Clinical Trials" on the member section of the website for the NCT numbers included with each trial summary.
We have recently submitted an estimated closure date for all studies, and will begin posting clinical trial results as is required.
If you have any questions at all, please feel free to contact me at email@example.com or LeeAnne Howland at firstname.lastname@example.org.