There is little doubt that the issue of clinical-trial registries will remain front and center in 2005.
Spurred on by concerns over drug safety, healthcare professionals and patients alike have demanded access to all information regarding trials and their results. In response, over the past few months, government agencies, industry associations,
and pharma companies have launched clinical-trial registries and results databases.
The objective is to make information about clinical trials—both initiation and results—available to healthcare professionals
and the public in an unbiased, scientific, and timely manner. Information is not limited to interpretations of a trial's results
or conclusions that can be drawn from a study. The results—positive or negative—are published in full. In principle, this
increased transparency should enhance patient care by giving physicians objective, comprehensive data on all products, including
those under development.
From the perspective of pharma companies, a trial registry can be used by investigators to facilitate patient enrollment in
clinical trials. The increased availability of information allows patients to identify trials in which they may participate,
assess safety and efficacy issues, and easily register to participate.
Registries also offer implied benefits, such as a potential reduction in the negative news coverage that currently undermines
consumers' faith in the clinical-trial process. Patients can use the information contained in the registry to track a particular
clinical study and identify issues for discussion with their physicians. Registries can offer significant benefits to consumers,
healthcare professionals, and the industry, but they must be set up effectively to realize these benefits. It is crucial for
pharma companies today to be aware of the rapid evolution of registries, and the strategies they employ to balance patient
welfare and the needs of companies performing drug development.
The Evolution of Registries
Today's registry movement began in Section 113 of the FDA Modernization Act (FDAMA) of 1997. Section 113 established the Clinical
Trials Data Bank (CTDB), which since February 2000, has made information available to the public through the National Library
of Medicine's site,
http://www.clinicaltrials.gov/. Registration within 21 days of inception is mandatory for all clinical studies involving serious or life-threatening diseases
or conditions. Specifically, Section 113 requires that CTDB contain the following:
1. Information about both federally and privately funded clinical trials of experimental treatments (including both drug and
biological products) for patients with serious or life-threatening diseases and conditions
2. Description of the purpose of each experimental treatment
3. Patient-eligibility criteria
4. Location of clinical-trial sites
5. Contact information for patients wishing to enroll.
Clinicaltrials.gov was designed to make consumers more aware of trials they could participate in. Posting of results was voluntary. But in many
ways the real impact of Section 113 has come more recently, as other groups—such as the American Medical Association (AMA),
the International Committee of Medical Journal Editors (ICMJE), and the International Federation of Pharmaceutical Manufacturers
and Associa-tions (IFPMA)—have adopted it as a platform upon which to build their own approaches.
Eli Lilly www.lillytrials.com