Clinical Trials Results Reporting: Update from London

While a record-breaking snowfall in London made travel difficult for speakers and attendees alike, the "show went on" for the Center for Business Intelligence's Inaugural Clinical Trial Registries and Results Databases conference held for the first time outside the United States.

The attendees-largely of course from Europe-came to learn more about the international registry requirements for clinical trials, as well as the newly-implemented clinical trials results requirements on clinicaltrials.gov. FDAAA's requirement called for the trial results implementation at the end of September 2008. We last reported on the topic in October. See, www.appliedclinicaltrialsonline.com/FDAAA

As was evident, pharma and government alike are struggling with these new transparency initiatives. While no one is against transparency in clinical trials, a number of issues regarding data, analysis, various stakeholders, ethics and more came to light during the conference. Nicholas Ide, chief architect of ClinicalTrials.gov said updated the attendees on the challenges they have had regarding information and data submitted to clinicaltrials.gov results. Of 250-plus results submitted, approximately 46 have been published to the Web site. The others? Sent back to sponsors with comments and questions. A spring meeting has not yet been formally scheduled to update the next steps in the clinicaltrials.gov clinical trials results reporting database.

Kevin Palmaccio, conference producer, noted that conference went very well, despite the weather challenges. "We made a lot of accomplishments here and a lot of good discussion with various stakeholders. More still needs to be done, but there is good momentum."

CBI's 4th Forum on Clinical Trials Registries and Results Databases will be held in Vienna, VA, April 21-22, where hopefully those new updates from clinicaltrials.gov will be available. Even so, the need for European-based information is clearly necessary. Palmaccio said that the organization will definitely hold a second event in Europe next year.

Editor's Note: A news article from this conference will appear in March. Also, CBI is an Advanstar Communications company, which is also the parent company of Applied Clinical Trials.