Study examines gap in federal oversight of clinical trials

March 4, 2014

An analysis of nearly 24,000 active human research clinical trials found that between 5 percent and 16 percent fall into a regulatory gap and are not covered by two major federal regulations, according to a study in the March 5 issue of JAMA. These trials studied interventions other than drugs or devices (e.g., behavioral, surgical).

The primary federal human subjects protections (HSP) policies in the United States, including requirements for institutional review board review and informed consent, are the U.S. Food and Drug Administration (FDA) HSP regulations and the Common Rule. "The first covers FDA-regulated clinical investigations of drugs, biologics, and devices, regardless of funding source, whereas the second applies to human studies funded or conducted by 17 federal entities, regardless of the type of intervention studied. These regulations are largely consistent but contain differences. Concerns have been raised about burdens and inefficiencies for studies covered by both regulations (overlap ), and about some studies that are covered by neither (gap trials).

Deborah A. Zarin, M.D., of the National Institutes of Health, Bethesda, Md., and colleagues conducted a study to estimate the number of active U.S.-based subject to these regulations. From ClinicalTrials.gov records of active trials listing at least 1 U.S.-based facility as of September 2013, the researchers extracted the intervention type, investigational new drug application or investigational device exemption status, sponsor, and collaborators and approximated the number of trials subject to each , using narrow and broad criteria.

Of the 23,936 sampled trials, the authors estimate that 13,165 (55 percent) to 15,576 (65 percent) trials were covered only by FDA-HSP regulations; 1,442 (6 percent) to 2,497 (10 percent) trials were subject only to the Common Rule; 4,578 (19 percent) to 5,633 (24 percent) were overlap trials that studied drugs and devices and have some ; and 5 percent to 16 percent were gap trials that studied interventions other than drugs or devices (e.g., behavioral, surgical) and had no federal funding. The characteristics of gap trials varied widely, but included research in vulnerable populations (e.g., pregnant women, people with major mental illness, children) with primary outcomes that reflected potentially consequential risk (e.g., organ failure, depression relapse, seizure frequency, hospitalization).

The authors write that their analysis provides the first quantitative estimate of the size of the gap in regulatory coverage, and also documents a large number of studies that are subject to both sets of regulations.

"Our data are not precise measures of the current scope of different regulatory categories. Rather, they represent the best current estimates [based on clinical trial registrations], and this analysis is intended to inform ongoing discussions about potential regulatory reforms."

Explore further: Clinical trial results for cancer drugs often not published

More information: DOI: 10.1001/jama.2013.284306

Related Stories

Clinical trial results for cancer drugs often not published

July 23, 2013
(HealthDay)—Although the U.S. Food and Drug Administration Amendments Act requires publication of the results of completed trials of cancer drugs conducted in the United States, results for almost half of the studies have ...

Results from many large clinical trials are never published

October 29, 2013
A new analysis of 585 large, randomized clinical trials registered with ClinicalTrials.gov finds that 29 percent have not been published in scientific journals. In addition, nearly 78 percent of the unpublished trials had ...

Study examines drug labeling and exposure in infants

December 9, 2013
Federal legislation encouraging the study of drugs in pediatric patients has resulted in very few labeling changes that include new infant information, according to a study by Matthew M. Laughon, M.D., M.P.H., of the University ...

"Evidence is weak" for cold treatment with echinacea

February 21, 2014
(Medical Xpress)—For people seeking a natural treatment for the common cold, some preparations containing the plant Echinacea work better than nothing, yet "evidence is weak," finds a new report from The Cochrane Library. ...

Slim pickings for two weight-loss drugs?

February 11, 2014
Options are limited in America's battle of the bulge. While diet and exercise can help in the short term, they are frustratingly ineffective in the long run.

Half of trial results in ClinicalTrials.gov not published

December 3, 2013
Half of trials with results posted in ClinicalTrials.gov database have not been published in a journal, and for some that have, the database contains more information.

Recommended for you

Drug therapy from lethal bacteria could reduce kidney transplant rejection

August 3, 2017
An experimental treatment derived from a potentially deadly microorganism may provide lifesaving help for kidney transplant patients, according to an international study led by investigators at Cedars-Sinai.

Exploring the potential of human echolocation

June 25, 2017
People who are visually impaired will often use a cane to feel out their surroundings. With training and practice, people can learn to use the pitch, loudness and timbre of echoes from the cane or other sounds to navigate ...

Team eradicates hepatitis C in 10 patients following lifesaving transplants from infected donors

April 30, 2017
Ten patients at Penn Medicine have been cured of the Hepatitis C virus (HCV) following lifesaving kidney transplants from deceased donors who were infected with the disease. The findings point to new strategies for increasing ...

'bench to bedside to bench': Scientists call for closer basic-clinical collaborations

March 24, 2017
In the era of genome sequencing, it's time to update the old "bench-to-bedside" shorthand for how basic research discoveries inform clinical practice, researchers from The Jackson Laboratory (JAX), National Human Genome Research ...

The ethics of tracking athletes' biometric data

January 18, 2017
(Medical Xpress)—Whether it is a FitBit or a heart rate monitor, biometric technologies have become household devices. Professional sports leagues use some of the most technologically advanced biodata tracking systems to ...

Financial ties between researchers and drug industry linked to positive trial results

January 18, 2017
Financial ties between researchers and companies that make the drugs they are studying are independently associated with positive trial results, suggesting bias in the evidence base, concludes a study published by The BMJ ...

0 comments

Please sign in to add a comment. Registration is free, and takes less than a minute. Read more

Click here to reset your password.
Sign in to get notified via email when new comments are made.