Articles/Links: Clinical Trials Registration

• An Act Regarding Advertising by Drug Manufacturers and Disclosure of Clinical Trials (Maine) Author: State of Maine – June, 2005
  This statute (P Me. Rev. Stat. Ann. Tit. 22 §2700-A) was the first state to require pharmaceutical companies to make all clinical trials results public. The law requires companies to report the name of those directing the trial, the purpose, dates and complete results. The U.S. Congress and 15 others states have introduced similar legislation. The link to the Maine CDC Clinical Trial Website is http://www.maine.gov/dhhs/boh/clinical_trials.htmREAD MORE »
• Clinical Trial Registration: Transparency Is the Watchword Authors: Editorial Board - 2006
  Publication: The Lancet
  This editorial advocates transparency as the remedy to growing distrust in the clinical trials industry. The editors argue that universal registration of trials will improve management, innovation, and ethical clarity in the global research community. The editors endorse the recommendations of the World Health Organization’s Registry Platform, which include full registration of even early-phase clinical trials, as well as complete and public disclosure of data gathered in trials before registration begins.
• Is this Clinical Trial Fully Registered? A Statement from the International Committee of Medical Journal Editors Authors: C. Angelis et al – May, 2005
  Publication: New England Journal of Medicine
  This statement, issued by the International Committee of Medical Journal Editors, calls for uniformity in registration and data entry of all clinical trials that aim to affect “medical decision-making.” Reiterating the Committee’s 2004 stand to only publish results of trials registered before the first participant is enrolled, the editors discuss the endorsed minimum data set requirement (as established by the World Health Organization), what constitutes adequately completed data fields, and the exceptions with regard to publication of trials. The editors assert that full registration and transparency of clinical trials is a globally relevant issue to the medical community and the public.
• Clinical Trials Registries: a Reform that is Past Due Authors: J. Gold and D. Studdert – 2005
  The authors advocate a comprehensive clinical trials registry to promote greater transparency, public accountability and access to clinical trials. Registries can help eliminate the positive publication bias and data suppression that currently undermines evidence based-medicine and informed policy-making. The authors discuss the existing public registries, their limitations and lay out a model for an ideal clinical trials registry. The recent legal cases around Vioxx and Paxil are cited as examples of how the health and trust of participants and the public at large has been compromised in the absence of such protections.