January 2008 2 Church Street South, Suite 114 | New Haven, Connecticut 06519 | p 203.785.3482 | f 203.737.2480
FDA Amendment Act Expands Mandatory Registering of Clinical Trials Inside This Issue 1 FDA Amendment Act Expands Mandatory Registering of Clinical Trials 1 Director’s Corner 2 Events Calendar 2 Funding for Career Development and Research 2 How New Amendment Will Affect Clinical Research 3 Expanded Trials Database to Include Results and Adverse Events 4 New Billing Policy for Clinical Trials 4 YCCI Launches Website
Terry Degradi
On September 27, a new law was enacted that expands the types of clinical trials that must be registered on the government-sponsored website clinicaltrials.gov and increases the information that must be submitted. The legislative push for registering clinical trials isn’t all that new. It actually began with the FDA Modernization Act of 1997, which required HHS to establish a registry so that the public would have access to clinical trials. As a result of this legislation, clinicaltrials.gov was established in 2000. However, only trials testing drugs for serious or life-threatening conditions needed to be registered, and there was virtually no enforcement that this was taking place. Not surprisingly, a 2002 FDA study found that only 48 percent of cancer drug trials were registered and a 2005 study found that 67 percent of companies required to register studies had complied. In response to a trend for greater public access to research funded by the federal government and in the wake of allegations that adverse events linked to Cox-2 inhibitors were being suppressed, the International Committee of Medical Journal Editors (ICMJE) announced a new policy in 2004: Any trials involving human subjects, medical interventions and health outcomes had to be registered in a public database (clinicaltrials.gov was the only one that met the organization’s criteria) in order for the study to be considered for publication in ICMJE journals. This policy included drugs, but unlike the FDA policy it also included devices and procedural interventions. Although it did not at that time include Phase I trials or pharmacokinetics studies, the ICMJE revised its policy in 2007 to include these trials as well. The ICMJE policy appears to have had a significant impact; at the time it was announced in 2004, about 13,000 trials were registered, but by April 2007, 40,000 trials had been registered. Since the policy’s inception, the World Health Organization, the American Medical Association and other groups have supported the registration of clinical trials, and some states have also mandated registration. The FDA Amendment Act of 2007 brings together the various elements involved in this issue:
Next Issue
• YCCI’s Educational Programs:
An in-depth look at the new programs plus profiles of the trainees and scholars
Now that we’ve just marked our one-year anniversary, I’m happy to report that we’ve made a lot of inroads toward achieving the objectives we established for the first year of the program. In addition to major programmatic goals, we have achieved more than 90 percent of the milestones we set out to accomplish in the first year. Here is some of what we’ve completed since October 2006:
•O pened our new facility at 2 Church Street with administrative offices and the clinical research unit • Launched the new YCCI Scholars program making 20 awards totaling just over $2.5 million • L aunched the YCCI pilot projects program awarding $740,000 in five areas • I nvested in the expansion of existing and new technologies for Cores to further genomics, proteomics, imaging, and immune biomarkers capabilities.
• It expands registration requirements to most trials of drugs, biologics and devices under FDA jurisdiction (including those approved under 510(k), PMA and HDE) • It includes pediatric post-marketing device trials
Director’s Corner
When YCCI was established, we set out to integrate Yale’s clinical and translational research programs and to create an academic home for students, fellows and junior faculty members from the schools of Medicine, Nursing, and Public Health, as well as biomedical engineering, who are committed to careers in clinical and translational research. Our goal was to establish a robust infrastructure that would promote innovative and collaborative research with the long-term goal of improving health.
The first year held many challenges for us, but it has also been an exciting time of growth and progress. As YCCI continues to evolve, we look forward to your continued advice and support in order to realize the vision and mission of the center.
Robert Sherwin, MD YCCI Director
• It preempts all state laws in this area continued on page 3
Announcing our Second Round Pilot Awards and Third Round Scholar Recipients See Funding for Career Development and Research article on page 2. January 2008 | Volume 1 | Issue 1 |