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Letter to Congress Supporting Bill to Expand Requirements to Report Studies to Clinicaltials.gov

October 03, 2012


Senator Barbara Mikulski
503 Hart Senate Office Building
Washington, DC 20510

Dear Senator Mikulski:

On behalf of AABB, I am writing to request your support for the Trial and Experimental Studies Transparency (TEST) Act, (H.R. 6272), recently introduced by Rep. Edward Markey (D-MA) in the House of Representatives. We urge you to support similar legislation in the Senate.

Located in Bethesda, MD, AABB (formerly known as the American Association of Blood Banks) is a not-for-profit professional and standard-setting organization dedicated to advancing transfusion medicine and cellular therapies. Our membership is comprised of approximately 1,800 institutions (including virtually every blood center in the United States) and 8,000 individuals involved in all aspects of blood and stem cell collection, processing, transfusion and transplantation. H.R. 6272 would take an important step forward in protecting patients and promoting biomedical research and efficient translation of novel transfusion, cellular and regenerative medicine therapies. We ask for similar legislation to be introduced and passed in the Senate.

The clinical trials registry (www.clinicaltrials.gov) was developed as a resource for patients, their families, health care professionals and other members of the public interested in gaining information on the status of clinical trials. Originally, the database focused on clinical trials encompassing experimental treatment for serious or life-threatening disease, but grew to encompass clinical trials on a broad range of drug and device interventions. Clinicaltrials.gov is now an important resource for patients considering participation in a clinical trial for acute or chronic diseases. The database also supplements the medical literature as a compendium of clinically-relevant information that is not published in the peer-reviewed literature, and serves as a snapshot of translational science for researchers and clinicians. However, the value of clinicaltrials.gov is diminished by absent, incomplete or delayed reporting of clinical trial activities. Some clinical trials are not required to be reported to clinicaltrials.gov and others are reported inadequately. 

The TEST Act aims to resolve these issues by capturing trials for which reporting is not currently required (including clinical trials conducted abroad to support marketing of a product in the U.S.), and by mandating timely reporting of results. Inclusivity and timeliness are both critical. In order to be able to make informed decisions about critical and potentially life-altering care, patients should have access to information regarding the full landscape of clinical trials as well as the results of similar trials. Given the difficulty of developing and translating novel therapies, researchers and sponsors also should be deterred from repeating unsuccessful, suboptimal or even harmful clinical trials due to lack of reporting of earlier trials. A more complete clinical trials registry with timely results reporting will protect patients and limit ill-advised expenditures of limited research resources.  

AABB strongly endorses this legislation and respectfully urges you to support its prompt introduction and passage in the Senate. Congress should act now to provide patients and clinicians with access to potentially life-saving information.  

Sincerely,
 
Karen L. Shoos
Chief Executive Officer, AABB