States move to mandate drug trial registration 

Maryland, Texas would require publishing results

Reacting to allegations that clinical trials showing unfavorable results often go unpublished, two states are proposing legislation that would require clinical researchers to register their studies with the NIH’s clinical trials database if they involve studies designed to evaluate a drug’s safety or effectiveness.

Although one measure would prohibit IRB approval of an unregistered study, passage of the laws should not affect IRB procedures significantly, experts say.

A bill currently under consideration in the Texas legislature (HB 1029) would prohibit IRB approval of any study designed to "evaluate the safety and effectiveness of a drug" unless the principal investigator agrees to register the trial with the NIH database and publish the results.

And three separate proposals before Maryland lawmakers would require registration of safety and efficacy studies of drugs and biologics, with one proposal calling for a penalty of $1,000 per day on researchers who fail to comply.

  • Maryland Senate Bill (SB) 289 would require registration of all research designed to determine whether a treatment is safe and efficacious. It prohibits an IRB from approving the research unless the results will be made publicly available and it will be registered with the NIH web site.
  • Maryland SB 681would include research that involves asking human volunteers to answer specific health questions, and any drug and biologic trial conducted under an IND. It requires the trial to be registered before Maryland residents can be enrolled, and provides a $1,000 per day penalty for not enrolling.
  • A competing House-sponsored measure, Maryland HB 54, would only require sponsors to submit trials to the NIH data bank. It is limited to trials testing the effectiveness of drugs and biologics under an investigational new drug (IND) application.

As this issue of IRB Advisor went to press, the state House of Representatives approved its measure and the others were still under consideration in the senate, says Jack Schwartz, assistant attorney general in Maryland Attorney General’s Office.

"The House bill, which deals only with registration of trials, was amended and passed the House unanimously," he explains. "The amendments to that bill basically conformed the state definition of clinical trial’ to the federal one, and also eliminated the monetary penalty. But, they retained the authority of the attorney general to seek to enjoin a trial that should have been registered but wasn’t."

The amendments probably served to assuage concerns by research institutions and pharmaceutical companies that Maryland would not be hindered in its ability to attract clinical research and the funding that accompanies it, he adds.

The two Senate bills still are in committee, but Schwartz says does not see the IRB continuing to be the body in charge of ensuring compliance with the new requirement, he said.

"I anticipate that, if the provisions on IRB approval remain, they will be modified so that the responsibility for compliance will rest with the PI, who would be responsible for carrying out commitments about registration and disclosure of trial results contained in the protocol submitted for IRB approval," he adds.

The current proposals should not significantly affect the IRB review process, says Paul Goebel, CIP, vice president of Chesapeake Research Review, an independent IRB and research consulting firm in Columbia, MD.

"An agreement to publish the results should not delay IRB review. Though, as written, there are no details on how soon after completion of the research the results must be published," he says. "And there is no indication of whether each trial must be published individually or whether similar trials can be combined into one article. Nor do they prohibit sponsors of multisite trials from publishing one article to cover all the sites in multiple states."

Trial registration is going to quickly become a fact of life, anyway, he notes. Most medical journals will no longer accept publication of data from trials that have not already been registered.

"There could be a requirement for registration to be completed before IRB review. This might delay the start of studies, but should not be a burden on IRBs if it is made clear the sponsor is required to do the registering and provide documentation to the IRB prior to review," Goebel says. "What would be a concern is if the bills did not require registration first, but then required IRBs to follow up after the fact and make sure registration is accomplished and publication is done."

The way the bills are written still does leave gaps in what types of trials would fall under the new requirement, with some drug and device trials still falling outside the jurisdiction, he notes.

"Most of the bills are limited to clinical research to show safety and effectiveness for FDA approval," he says. "Maryland SB 681 includes surveys and drug and biologic trials, but not device trials. So the coverage is spotty. Many trials of drugs and biologics are not conducted under INDs or IDEs [investigational device exemptions]."

More information on the Maryland proposals is available on the Maryland Attorney General’s website at: www.oag.state.md.us/Healthpol/.