The Emergence and Growth of Clinical Trial Information Transparency
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The Emergence and Growth of Clinical Trial Information Transparency
Pomelo A. Rose, RN, BS, FNP, ASQ-CMQOE Associate Director. Clinical Trial Registration and Results Disclosure, Takeda Global Research and Development Center, Inc., h k e Forest. Illinois
Key Words Clinical trial disclosure; Registration;Transparency; FDAAA; FDAMA Correspondence Address Pamela A. Rose, Associate Director. Clinical Trial Registration and Results Disclosure, Takeda Global Research and Development Center. Inc.. 675 N. Field Drive. Lake Forest. IL 60045 (email: [email protected]).
Clinical trial disclosure initiatives have slowiy emerged in response to stakeholder and public response to questions of s a f e and efficacy of drugs and perceived secrecy ty the pharmaceutical industry. Originally, clinical trial disclosure and tmnsparency activities focused upon thempeutic compounds of interest to seriously ill patients who hoped that ty participating in clinical trials, they might contribute to the development of efixtive drug treatments for their
IN T R O D U C T I 0 N Clinical trial transparency has slowly emerged over the course of 20 years in response to a wide group of stakeholders, including prominent medical journal editors and legislators, and public response to questions of safety and efficacy of drugs and the seeming concealment of data by the clinical research community (ie, pharmaceutical, biotechnology, and medical device industry). Over the years, additional stakeholders, including governmental agencies and academic clinical researchers, have entered the landscape and have influenced an expansion in the transparency requirements from those that meet patient needs to those that meet physician, researcher, payor, and legislator needs.
INCREASING REQUIREMENT FOR TRANSPARENCY The first major stepping stone toward increased transparency of clinical trial information occurred in 1988 (Figure 1). The US Congress passed the Health Ominbus Programs Extension Act in response to lobbying efforts by patients with AIDS seeking information on clinical trials in the hope of enrolling in these trials (1). As a result, the AIDS Clinical Trials Information Service (ACTIS) was implemented. A toll-free number was implemented and callers were given contact information for investigative sites
disease and to the common goal. Over the years, additional stakeholders have entered the discussion, causing an expansion in the transparency requirements, from meeting patients’ and their physicians’ needs for information to meeting researcher, insurer, and legislator needs. This article provides a brief I d at the history of the clinical trial disclosure initiative as it has evdved woddwide.
conducting AIDS research. A database with this information was also available on the National Library of Medicine website. After implementation, studies registered in the ACTIS database were transferred to the ClinicalTrials.gov database, which was launched in February 2000. Not until nearly 10 years later, in November 1997, was Section 1l3 added
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