Expansion of Clinicaltrials.gov

Another interesting article in the last issue of NEJM on the expansion of clinicaltrials.gov, a topic which is very relevant to the development of ClinicalTrialsWiki.org.

Feb 19, 2009 Volume 360:824-830, NEJM
http://content.nejm.org/cgi/content/full/360/8/824

Effective since September 27, 2008 section 801 of the registration and reporting requirements of the FDA amendments Act has been expanded to include the mandatory reporting of basic results of clinical trials that were ongoing on or after September 27, 2007. As Dr. Allastair Wood suggests, the expansion of the FDA amendment section 801 is an essential step forward for the public availability of clinical trial information. The author also emphasizes that this advance remains to be completed by further broadening the reporting requirements and by providing a source of clear and comprehensible review of clinical trial results.

"Ethical clinical research should contribute to generalizable knowledge and improve human health. The dedication of patients who take the risks to participate in clinical research is dishonored when their data remain secret. Section 801 of the FDA Amendments Act will greatly expand the type and amount of information available on clinical trials. The use of these data and the enhanced public access to the FDA's database on clinical trials proposed in this article will greatly improve the ability of investigators and others to assess the full set of results for a given intervention, whether FDA-approved or not, eventually leading to more accurate systematic reviews, better clinical decision making, improved patient care, and improved research efficiency and safety."

Reading this article, I thought ClinicalTrialWiki.org is emerging just in time to complement the expansion of section 801 by:
1) Providing access to clinical trial information: The "news" tab of ClinicalTrialWiki.org will provide a comprehensive source of publicly available information on ongoing and completed Clinical Trials, easily accessible to health care professionals.
2) Opening the discussion to all caregivers via the "public views" tab.
3) Providing clear and understable analysis of clinical trials: In an effort to disseminate rigorous and unbiased information to the public, a panel of experts analyzes discusses and criticizes each clinical trial in the "expert views" tab.