Markey, House Dems Introduce Bill to Protect Human Subjects in Clinical Trials
TEST Act ensures disclosure of critical information about
clinical trials and complete information about products on
market
WASHINGTON, D.C. August 2, 2012– Despite containing valuable
information that could benefit patients and protect additional ones
from risk, many clinical trials involving human subjects are not
registered in a publicly-accessible federal database and are not
reporting critical study results. Congressman Edward J. Markey
(D-Mass.), senior member of the Energy and Commerce Committee,
today introduced H.R. 6272, the Trial and Experimental Studies
Transparency (TEST) Act of 2012 to close these clinical trial
loopholes and bring certainty and transparency to life-saving
research studies. One of these loopholes results in registered
trials never reporting study results, putting future human
participants at risk if a different company decides to develop the
same drug, but without important safety information from the
previous study. The TEST Act 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 United States.
Eighty percent 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. The TEST Act is
co-sponsored by Reps. Henry A. Waxman (D-Calif.), Rosa DeLauro
(D-Conn.), and Jan Schakowsky (D-Ill.).
Updated by Congress in the Food and Drug Administration 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, senior
member of the Energy and Commerce Committee. “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. I look forward to working with my colleagues
on this legislation.”
“We took a significant step forward in 2007 when we enacted
legislation to establish the clinical trials database,” said
Rep. Waxman, Ranking Member of the Energy and Commerce Committee.
“Companies are no longer able to hide negative study results,
while emphasizing the positive ones. But there is more to do. This
legislation will bring to light critical additional information
about clinical trials that companies are not currently required to
disclose. It also clarifies that all clinical trials used to
support an application for product approvals in the U.S. are
subject to the database requirements, even if those trials are
conducted abroad. That is good for patients, doctors, and
researchers alike.”
“The Clinical Trial Registry Data Bank is a valuable source
of public information on human clinical trials,” said Rep.
DeLauro. “Closing loopholes and strengthening reporting
standards will help both Americans who want to do their due
diligence on a particular drug or device and researchers evaluating
the safety or efficacy of a drug. This bill will provide increased
transparency to clinical trials and their results—both
positive and negative—improving public health in the
process.”
“It is important to close existing loopholes in requirements
for registration and reporting of clinical trials to ensure
patients can make informed medical decisions and are not subject to
unsafe risks,” said Rep. Schakowsky. “This bill would
strengthen enforcement of important mechanisms to improve patient
and consumer safety. Not only would all clinical trials be required
to report their data regardless of FDA approval, it would allow for
analysis of the safety as well as efficacy of drugs and devices.
Increasing transparency while clarifying the registration and
reporting requirements will maintain the Clinical Trial Registry
Data Bank as a trusted resource.”
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.
“Women and their doctors can’t make good decisions
about their health care without good information,” said
Cynthia Pearson, Executive Director, National Women's Health
Network. “The TEST Act will help women get the information
they need by closing loopholes that allow companies to avoid
registering the existence and results of clinical trials. This bill
will improve access to evidence-based information so that patients
and consumers can make informed medical decisions.”
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.
In November 1986, Rep. Markey released a report entitled
“American Nuclear Guinea Pigs: Three Decades of Radiation
Experiments on U.S. Citizens”. The report documented
thirty-one human radiation experiments on nearly 700 individuals.
As a result of the report, in 1004 President Bill Clinton created
the Advisory Committee on Human Radiation Experiments and tasked it
with reviewing human radiation experiments conducted between 1944
and 1974. The final report, released in 1996, included
recommendations on protection for human subjects in future clinical
trials.
Contact: Giselle Barry (Markey) 202-225-2836
Karen Lightfoot (Waxman) 202-225-5735
Sara Lonardo (DeLauro) 202-225-3661
Adjoa Adofo (Schakowsky) 202-225-2111
Posted: August 2012
