- CONDITION CENTERS
Facing heightened public concern over the safety of drugs, pharmaceutical companies have launched new Web sites to publish comprehensive data on initiated and completed clinical trials, and they have pledged to support established on-line trial summary sites. The drug company initiatives to make more clinical data publicly availableand post details of new trials as they are launchedare part of an industry-wide promotion of clinical trial transparency, as professionals and patients have demanded broader and more timely access to trial information.
The new Web repositories promise to enable better health care decisions. They also will help to counter public skepticism arising from more frequent challenges on product safety, and the widely publicized withdrawals of drugs such as Merck's rofecoxib (Vioxx) acute pain reliever and Biogen Idec Inc's natalizumab (Tysabri) multiple sclerosis drug.
In April 2005, Roche introduced www.roche-trials.com, following Eli Lilly's launch of www.lillytrials.com in December 2004. Merck officials have said that the company will post information on phase 3 and 4 trials at the National Institutes of Health's (NIH's) clinical trial registry site, www.clinicaltrials.gov, GlaxoSmithKline (GSK) last year was the first to launch a dedicated Web site, the GSK Clinical Trial Register (http://ctr.gsk.co.uk), which will include a database of trial results for all of its marketed drugs.
Roche officials said that the company will publish the protocol details and results of all phase 2 through 4 trials completed after October 2004, and then add the results for medications marketed since October 2002, on a site hosted by Thomson CenterWatch, the trial site and publishing company. It will take a year to populate the trial registry and database with studies on >30 medications, Roche officials added.
Lilly is featuring the results from all phase 1 through 4 clinical trials of marketed products on lillytrials.com. On the registry side, protocols of phase 2 through 4 clinical trials will be posted upon trial initiation. Starting next year, Lilly will post the summary data on initiated phase 2 through 4 trials for all drugs at clinicaltrials.gov, where trial registration has been required only for drugs covering serious or life-threatening diseases.
"We, as a company, have publicly committed previously to make all data that would be relevant and helpful to doctors available to all physicians, whether favorable or unfavorable," said Ed Sagebiel, Eli Lilly manager of corporate communications. "Lillytrials.com is an extension [of that effort], promoting a goal of becoming transparent with regard to Lilly medications and clinical trial results, with an extremely user-friendly central repository for doctors, patients, and others,"said Sagebiel.
Lillytrials.com features a top-of-the-page contents line with drop-down menus, where the user can locate trial information by product or by therapeutic area and find lists of initiated trials and recruiting trials. "Terminology"and "education"tabs lead to key terms and definitions, as well as to an overview of the drug-development process. The page provides links to resources such as published literature and a "word"search engine.
Works in Progress
GSK is similarly posting phase 1 through 4 trial results on approved products in its Web site database. "It's still a work in progress. We are providing extensive data about all trials of marketed products around the world. We expect to have more than 1000 studies posted by the end of the year,"said GSK spokesman Rick Koenig.
GSK will publish at clinicaltrials.gov. protocol summaries on initiated trials for all drugs. "We are expanding our postings to the NIH site, which informs people about trials in which they can participate, and also creates a record against which people can subsequently track our progress in disclosure," said Koenig.
Lilly and GSK are among the companies planning to populate clinicalstudyresults.org with the results of hypothesis testing (typically phase 3 and 4) studies of approved drugs. The Pharmaceutical Research and Manufacturers of America (PhRMA) launched the site in October 2004 as a reader-friendly, standardized database of published articles and unpublished summaries of clinical results. Organization officials have urged companies to post trial results within 1 year of completion for marketed drugs.
PhRMA this year joined associations representing drug manufacturers worldwide in issuing guidelines for posting the launch of clinical trials and summarizing results of trials for approved drugs. The guidelines call for the use of lay terminology. They also state that new trials, other than phase 1 exploratory trials, should be listed on public registries within 21 days of the start of patient enrollment. Trials should be assigned unique identifiers, allowing users to track them through their multiple stages and after the trial data are included in a database.
Push for More Disclosure
The push for more disclosure has been taken up by groups including the American Medical Association, which has called for the creation of a single clinical trials repository. Last year, the International Committee of Medical Journal Editors said that it will require, as a condition for publishing studies in member journals, that companies list clinical trials in public registries at or before the onset of patient enrollment, starting in July 2005.
As they release more trial data, companies are balancing the demand for openness with the need to protect proprietary knowledge. Although the new Web sites are meant to be user-friendly, the concern has been raised that patients will be overwhelmed by the complex protocol and results data.
As the drug safety issue has led to calls in Congress for more oversight, the FDA is creating an independent Drug Safety Oversight Board. The board will draw on experts from other government departments and consult with patient and consumer groups, in monitoring drug safety and alerting the public to safety concerns. One question is whether the board will be looking at products before they even come to market.
"We are still trying to obtain a better sense of what the FDA [officials are] seeking to do in this role,"said Lilly's Sagebiel. "We share their concern about patient safety and generally support it. However, we are still waiting for details on their intentions and goals."
Mr. Vaczek is a freelance medical writer based in Yonkers, NY.