Clinical Trials Registration Bill From Democrats Includes Monetary Penalties

A House and Senate bill mandating clinical trial registration uses institutional review board approval and civil monetary penalties to enforce compliance.

The ¹ Fair Access to Clinical Trials Act was introduced Oct. 7 by Sens. Christopher Dodd (D-Conn.), Edward Kennedy (D-Mass.), Ron Wyden (D-Ore.), and Tim Johnson (D-S.D.) and Reps. Henry Waxman (D-Calif.) and Edward Markey (D-Mass.).

The FACT Act requires all clinical trials for drugs, biologics and medical devices to be registered on the National Institutes of Health's ClinicalTrials.gov website in order to obtain IRB approval.

Postings must include trial objectives, eligibility criteria, funding sources, anticipated timeline and a unique identification number.

Once studies are completed, sponsors must post a summary of results, including primary and secondary outcomes and significant adverse events and citations of published journal articles.

The bill also provides for civil monetary penalties of up to $10,000 a day for non-compliance and gives HHS authority to audit information in the registry.

Penalties collected under the law would be used "to make awards of grants, contracts or cooperative agreements for the conduct of comparative clinical trials to determine the safety or relative effectiveness of products."

The bill's provisions meet the criteria for a trial registry set by the International Committee of Medical Journal Editors and the recommendation of the American Medical Association, a summary sheet issued by the sponsors notes.

The ICMJE announced in September that it would require controlled clinical trials to be registered at inception in order for their results to be considered for publication (² , p. 5).

The American Medical Association called for HHS to establish a formal registry for clinical trials at its annual meeting in June (³ (Also see "HHS Registry Of Clinical Trials Proposed By AMA To Limit Publication Bias" - Pink Sheet, 21 Jun, 2004.), p. 6).

The Pharmaceutical Research & Manufacturers of America launched a voluntary online registry for clinical trial results Oct. 1, although it stops short of what would be required under the FACT Act.

PhRMA's site aims to include summaries or citations of "hypothesis-testing" clinical trial results but does not include a registration of studies at inception (⁴ , p. 7).

GlaxoSmithKline plans to register all GSK-sponsored trials enrolling patients on ClinicalTrials.gov.

"We've already been doing this for serious and life-threatening disease. We will now register all trials being done in patients," GSK Senior VP-Biomedical Data Sciences Frank Rockhold, PhD, told a Food & Drug Law Institute audioconference Oct. 6.

GSK is also required to post results of clinical trials for marketed products on its own website under a settlement with the New York Attorney General (⁵ (Also see "Paxil Settlement Requires Disclosure Of Early Phase Research" - Pink Sheet, 6 Sep, 2004.), p. 11).

"We are actually quite willing to work with others to establish an international register for trials that are initiating patient enrollment," Rockhold noted. "In the meantime, we will begin to register before the end of this year all GSK-sponsored patient trials...while we're waiting for those discussions to take place."

GSK's trial registration will include Phase I trials if they are being done in "patients" - not healthy volunteers. The status of early-stage research has been a point of contention in discussion on registries (⁶ (Also see "Merck Defends Right Not To Publish Clinical Trials" - Pink Sheet, 13 Sep, 2004.), p. 10).

Senate Health Committee Health Policy Fellow Gary Matzke noted during the FDLI audioconference that GSK's approach to Phase I was a "reasonable compromise."

"Healthy volunteers will find their way into trials and those are not usually the type of trials that we see and hear of difficulties with enrollment," Matzke said.

The FACT Act currently has no Republican sponsors, but Senate Health Committee Chairman Judd Gregg (R-N.H.) aims to introduce legislation on clinical trial databases this session, Matzke said. Given the limited number of days remaining in the congressional session, movement on legislation is unlikely this year.