DeLauro, Markey, House Dems Introduce Bill to Protect Human Subjects in Clinical Trials

TESTAct ensures disclosure of critical information about clinical trials andcomplete information about products on market

WASHINGTON (May 16, 2013) – Manyclinical trials involving humans are still not registered in apublicly-accessible database and critical study results are not reported,putting people participating in the studies at risk due to lack of informationsharing among studies. In order to protect study participants, close dangerousloopholes, and bring certainty and public transparency to life-saving researchstudies, Reps. Rosa DeLauro (D-Conn.), Ed Markey (D-Mass.) and other HouseDemocrats introduced new legislation to take the errors out of clinical trialreporting.

The Trial and ExperimentalStudies Transparency (TEST) Act of 2013 updates and expands the clinical trialregistry data bank – clinicaltrials.gov – with stronger reporting requirements,and requires that all foreign clinical studies meet the same registration andreporting requirements as domestic trials if they are used to support anapplication to market a product in the United States. Eighty percent of thedrugs entering the U.S. market in 2008 were clinically tested overseas and a growingnumber of device trials are also moving abroad. Many of these trials are notrequired to be registered with the clinical trials database.

The TEST Act is co-sponsored byReps. Henry A. Waxman (D-Calif.) and Jan Schakowsky (D-Ill.). A previous versionof the legislation was introduced last year.

Led by the efforts of Reps. Markey and Waxman,clinicaltrials.gov was updated by Congress in 2007 to become a mandatoryregistry, directly addressing issues stemming from a lack of transparency ofclinical trials. High-profile examples included Paxil®, Avandia®, andVioxx® trials, in which safety concerns and negative results were suppressed bythe drug companies, leading to injuries to patients and in some cases death.Today, Clinicaltrials.gov contains more than 145,000 trials and more than 8,000results posted and has become a trusted and common resource for informationabout human trials.

"The Clinical Trial RegistryData Bank is a valuable source of public information on human clinical trials,"said Rep. DeLauro. "Closing loopholes and strengthening reportingstandards will help both Americans who want to do their due diligence on aparticular drug or device and researchers evaluating the safety or efficacy ofa drug. This bill will provide increased transparency to clinical trialsand their results—both positive and negative—improving public health in theprocess."

"If we were issuing a grade onthe clinical trials report card, it would be Incomplete," said Rep. Markey,senior member of the Energy and Commerce Committee. "Unreported results andmissing registrations leave participants, doctors and researchers vulnerable.

Significant strides have beenmade since we established this registry in 2007, and the TEST Act will createadditional certainty regarding registration and reporting requirements andpromote transparency in clinical trials. Strengthening standards for reportingoutcomes will help maintain the trust of clinical trial participants and avoidputting people unnecessarily at risk. I look forward to working with mycolleagues on this legislation."

"We took a significant stepforward in 2007 when we enacted legislation to establish the clinical trialsdatabase," said Rep. Waxman, Ranking Member of the Energy and CommerceCommittee. "Companies are no longer able to hide negative study results,while emphasizing the positive ones. But there is more to do. Thislegislation will bring to light critical additional information about clinicaltrials that companies are not currently required to disclose. It alsoclarifies that all clinical trials used to support anapplication for product approvals in the U.S. are subject to the databaserequirements, even if those trials are conducted abroad. That is good forpatients, doctors, and researchers alike."

"Thisbill would strengthen enforcement of important mechanisms to improve patientand consumer safety. As a result, patients would have increased ability to makeinformed medical decisions and clinical trial participants would not be subjectto unsafe risks that have been previously identified. Clarifying theregistration and reporting requirements and increasing transparency will ensurethe Clinical Trial Registry Data Bank remains a trusted resource for patients,doctors, and researchers," said Rep. Schakowsky.

A copyof the legislation can be found HERE.

TheTEST Act will:

--Requireall interventional biomedical studies on humans to be registered with thedatabase before the first participant is enrolled in the trial.

--Strengthenreporting requirements so that results from all covered trials are posted onthe database within one year of the completion of the trial.

--Providefor delayed submission of results (up to two years after trial completion) fortrials on medical interventions that have never before been approved for anyuse.

--Instructthe Secretary of HHS to undergo a rulemaking to require foreign trials that areused to support an application for marketing in the U.S. to comply with theregistration and reporting requirements of the database.

--InstructNIH and the FDA to provide a report to Congress regarding the implementationand compliance with the database requirements.

Thelegislation is supported by the Patient,Consumer and Public Health Coalition and ConsumersUnited for Evidence-Based Healthcare, whose members include:American Medical Women's Association, Annie Appleseed Project, Black Women'sHealth Imperative, Breast Cancer Action, Center for Medical Consumers, Centerfor Science in the Public Interest, Childbirth Connection, Consumer Federationof America, Consumers Union, CT Center for Patient Safety, Jacobs Institute ofWomen's Health, LymeDisease.org, National Coalition for LGBT Health, NationalConsumers League, National Physicians Alliance, National Research Center forWomen & Families Cancer Prevention and Treatment Fund, National Women'sHealth Network, Our Bodies Ourselves, Public Citizen, Reproductive HealthTechnologies Project, The TMJ Association, Union of Concerned Scientists, U.S.PIRG, and Woody Matters.