August 16, 2012

Clinical Study Report Tightening in New Proposed Legislation

Thumbnail image for 3699948229_d7732f8df0_o.jpgOn August 2, four members of the House of Representatives, led by Congressman Edward Markey, introduced, H.R. 6272, "The Trial and Experimental Studies Transparency (TEST) Act of 2012." The TEST Act will amend Section 402(j) of the Public Health Service Act, tightening the reporting requirements for the Internet site designed to better inform the public about ongoing and completed clinical trials in the United States, ClinicalTrials.gov. The main goal of the TEST Act is to prevent clinical-trial sponsors from withholding negative study data and safety concerns while emphasizing the positive results of their clinical trials.

Prior to the proposed TEST Act, under the Food and Drug Administration Amendments Act of 2007 ("FDAAA"), most United States-conducted interventional clinical trials were registered at ClinicalTrials.gov, and most of the results of those clinical studies were eventually published. However, loopholes in the requirements of the FDAAA resulted in clinical studies that were either not registered, that failed to report results, or both. There are a number of clinical trials, therefore, that are not registered in the publically-accessible database.

The TEST Act will require all interventional biomedical studies conducted on humans to be registered on ClinicalTrials.gov prior to enrolling any patients. In addition, sponsors of these clinical trials will be required to post the study results and other required information on ClinicalTrials.gov within one year of the completion date of the trial. According to the proposed legislation, interventional studies include all human studies where patients are assigned, via protocol, by an investigator to receive specific intervention where the effects of such intervention on biomedical or health-related outcomes are evaluated. For clinical trials involving drugs or medical devices that have never been approved for any use, the TEST Act permits a delayed results submission of up to two years from the date of completion of the clinical trial.

Unlike under the FDAAA, all interventional studies--including phase I trials and trials where the drug is not submitted to FDA for approval--must comply with the registration and reporting requirements. In addition, all clinical trials conducted outside of the United States but used in support of an application for marketing within the United States, must also follow the new requirements.

Congressman Markey summarized the goal of this legislation by stating:

Unreported results and missing registrations leave participants, doctors and researchers vulnerable. Significant strides have been made since we established [ClinicalTrials.gov] 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.
The TEST Act would enhance the value of ClinicalTrials.gov by providing the public with accurate and complete safety and efficacy information for drugs and devices of interest.