Markey, House democrats introduce bill to protect human subjects in clinical trials
Monday, August 6, 2012
Rep. Edward J. Markey (D-Mass.), senior member of the Energy and Commerce Committee, has introduced H.R. 6272, the Trial and Experimental Studies Transparency (TEST) Act of 2012 to close clinical trial loopholes and bring certainty and transparency to life-saving research studies.
The bills aims to rectify the fact that many clinical trials involving human subjects are not registered in a publicly-accessible federal database and are not reporting critical study results. Currently, human participants who are involved in more than one clinical trial during their life time may be at risk if a different company decides to develop the same drug, but does not have access to important safety information from the previous study.
The TEST Act, co-sponsored by Reps. Henry A. Waxman (D-Calif.), Rosa DeLauro (D-Conn.), and Jan Schakowsky (D-Ill.), updates and expands the clinical trial registry data bank—clinicaltrials.gov—with stronger reporting requirements, and requires that all foreign clinical studies meet the same requirements as domestic trials if they are used to support an application for marketing in the U.S. About 80% of the drugs entering the U.S. market in 2008 were clinically tested overseas and a growing number of device trials are also moving abroad. Many of these trials are not required to be registered with the clinical trials database.
Updated by Congress in the FDA Amendments Act (FDAAA) of 2007 to become a mandatory registry, clinicaltrials.gov directly addresses issues stemming from a lack of transparency of clinical trials. High-profile examples included Paxil, Avandia and Vioxx, trials where safety concerns and negative results were suppressed by the drug companies. Clinicaltrials.gov now contains more than 130,000 trials and more than 6,000 results posted and has become a trusted and common resource for information about human trials.
“If we were issuing a grade on the clinical trials report card, it would be ‘Incomplete,’” said Rep. Markey. “Unreported results and missing registrations leave participants, doctors and researchers vulnerable. Significant strides have been made since we established this registry in 2007, and the TEST Act will create additional certainty regarding registration and reporting requirements and promote transparency in clinical trials. Strengthening standards for reporting outcomes will help maintain the trust of clinical trial participants and avoid putting people unnecessarily at risk.”
A copy of the legislation can be found here.
The TEST Act will:
- Require all interventional biomedical studies on humans to be registered with the database before the first participant is enrolled in the trial
- Strengthen reporting requirements so that results from all covered trials are posted on the database within one year of the completion of the trial
- Provide for delayed submission of results (up to two years after trial completion) for trials on medical interventions that have never before been approved for any use
- Instruct the Secretary of HHS to undergo a rulemaking to require foreign trials that are used to support an application for marketing in the U.S. to comply with the registration and reporting requirements of the database
- Instruct NIH and the FDA to provide a report to Congress regarding the implementation and compliance with the database requirements
The legislation is supported by the Patient, Consumer and Public Health Coalition and Consumers United for Evidence-Based Healthcare, whose members include: American Medical Women’s Association, Annie Appleseed Project, Black Women’s Health Imperative, Breast Cancer Action, Center for Medical Consumers, Childbirth Connection, Consumer Federation of America, Consumers Union, CT Center for Patient Safety, Jacobs Institute, LymeDisease.org, National Coalition for LGBT Health, National Consumers League, National Research Center for Women & Families Cancer Prevention and Treatment Fund, National Women’s Health Network, Our Bodies Ourselves, Public Citizen, Reproductive Health Technologies Project, The TMJ Association, Union of Concerned Scientists, U.S. PIRG and Woody Matters.