Drug Firms Disclosing Trial Results Through New Web Sites
Facing heightened public concern over the safety ofdrugs, pharmaceutical companies have launched newWeb sites to publish comprehensive data on initiatedand completed clinical trials, and they have pledged to supportestablished on-line trial summary sites. The drug companyinitiatives to make more clinical data publicly available—and post details of new trials as they are launched—arepart of an industry-wide promotion of clinical trial transparency,as professionals and patients have demanded broaderand more timely access to trial information.
The new Web repositories promise to enable better healthcare decisions. They also will help to counter public skepticismarising from more frequent challenges on product safety,and the widely publicized withdrawals of drugs such asMerck's rofecoxib (Vioxx) acute pain reliever and BiogenIdec 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 December2004. Merck officials have said that the company willpost information on phase 3 and 4 trials at the NationalInstitutes of Health's (NIH's) clinical trial registry site,www.clinicaltrials.gov, GlaxoSmithKline (GSK) last year wasthe first to launch a dedicated Web site, the GSK Clinical TrialRegister (http://ctr.gsk.co.uk), which will include a databaseof trial results for all of its marketed drugs.
Roche officials said that the company will publish the protocoldetails and results of all phase 2 through 4 trials completedafter October 2004, and then add the results for medicationsmarketed since October 2002, on a site hosted byThomson CenterWatch, the trial site and publishing company.It will take a year to populate the trial registry and databasewith studies on >30 medications, Roche officials added.
Lilly is featuring the results from all phase 1 through 4clinical trials of marketed products on lillytrials.com. On theregistry side, protocols of phase 2 through 4 clinical trialswill be posted upon trial initiation. Starting next year, Lillywill post the summary data on initiated phase 2 through 4trials for all drugs at clinicaltrials.gov, where trial registrationhas been required only for drugs covering serious orlife-threatening diseases.
"We, as a company, have publicly committed previously tomake all data that would be relevant and helpful to doctorsavailable to all physicians,whether favorableor unfavorable,"said Ed Sagebiel, Eli Lillymanager of corporatecommunications."Lillytrials.com is anextension [of that effort],promoting a goalof becoming transparentwith regard to Lillymedications and clinicaltrial results, with an extremely user-friendly central repositoryfor doctors, patients, and others,"said Sagebiel.
Lillytrials.com features a top-of-the-page contents linewith drop-down menus, where the user can locate trialinformation by product or by therapeutic area and find listsof initiated trials and recruiting trials. "Terminology"and"education"tabs lead to key terms and definitions, as wellas to an overview of the drug-development process. Thepage provides links to resources such as published literatureand a "word"search engine.
Works in Progress
GSK is similarly posting phase 1 through 4 trial results onapproved products in its Web site database. "It's still a workin progress. We are providing extensive data about all trialsof marketed products around the world. We expect to havemore than 1000 studies posted by the end of the year,"saidGSK spokesman Rick Koenig.
GSK will publish at clinicaltrials.gov. protocol summarieson initiated trials for alldrugs. "We are expandingour postingsto the NIH site, whichinforms people abouttrials in which theycan participate, andalso creates a recordagainst which peoplecan subsequently trackour progress in disclosure,"said Koenig.
Lilly and GSK areamong the companies planning to populate clinicalstudyresults.org with the results of hypothesis testing (typically phase3 and 4) studies ofapproved drugs. ThePharmaceutical Researchand Manufacturersof America(PhRMA) launched thesite in October 2004 asa reader-friendly, standardizeddatabase ofpublished articles andunpublished summariesof clinical results.Organization officials have urged companies to post trialresults within 1 year of completion for marketed drugs.
PhRMA this year joined associations representing drugmanufacturers worldwide in issuing guidelines for postingthe launch of clinical trials and summarizing results of trialsfor approved drugs. The guidelines call for the use of lay terminology.They also state that new trials, other than phase 1exploratory trials, should be listed on public registries within21 days of the start of patient enrollment. Trials shouldbe assigned unique identifiers, allowing users to track themthrough their multiple stages and after the trial data areincluded in a database.
Push for More Disclosure
The push for more disclosure has been taken up by groupsincluding the American Medical Association, which has calledfor the creation of a single clinical trials repository. Last year,the International Committeeof Medical JournalEditors said that it willrequire, as a condition forpublishing studies inmember journals, thatcompanies list clinical trialsin public registries ator before the onset ofpatient enrollment, startingin July 2005.
As they release moretrial data, companies are balancing the demand for opennesswith the need to protect proprietary knowledge. Althoughthe new Web sites are meant to be user-friendly, the concernhas been raised that patients will be overwhelmed by thecomplex protocol and results data.
As the drug safety issue has led to calls in Congress formore oversight, the FDA is creating an independent DrugSafety Oversight Board. The board will draw on experts fromother government departments and consult with patient andconsumer groups, in monitoring drug safety and alerting thepublic to safety concerns. One question is whether the boardwill be looking at products before they even come to market.
"We are still trying to obtain a better sense of what theFDA [officials are] seeking to do in this role,"said Lilly'sSagebiel. "We share their concern about patient safety andgenerally support it. However, we are still waiting for detailson their intentions and goals."
Mr. Vaczek is a freelance medical writer based in Yonkers, NY.