Tufts Center for the Study of Drug Development

About: Tufts Center for the Study of Drug Development is a based out in . It is known for research contribution in the topics: Drug development & Clinical trial. The organization has 78 authors who have published 258 publications receiving 16047 citations.

The Food and Drug Administration Modernization Act and the Food and Drug Administration: Metamorphosis or Makeover?

Abstract: The Food and Drug Administration Modernization Act of 1997 (FDAMA) is the first legislation to bring about significant and widespread modifications to the regulatory environment for drugs and biologicals in more than 35 years. The expectations of what FDAMA is to accomplish are high. This article reviews the results from the first two years of implementation of the major FDAMA provisions for drugs and biologicals. First, however, the elements of the adversarial culture that brought about the impetus to modernize FDA are discussed. Next the article focuses on FDA’s more “modernized” approach to the process of governing, through the use of such mechanisms as governance by guidance, direct final rules, national videoconferences, and stakeholders meetings. In addition, the process for implementing FDAMA and what the products of that process have been, both the rules themselves and the outcomes for the regulated community, are discussed. Lastly, the article considers whether FDA is capable of change and what the real message of FDAMA is.

Opportunities to Optimize Study Design to Drive Development Performance and Efficiency

Abstract: During this past decade, a growing body of research in the literature has revealed a sobering trend demanding remediation: Study design complexity across a variety of parameters, including the number of protocol endpoints and objectives and the number of volunteer eligibility requirements, have been

Can Medicare Draw Lessons from Dutch Experience with a National Formulary

Abstract: Objective: Using seven therapeutic subclasses of cardiovascular drugs as a case study, we investigated how different systems of formulary practice have an impact on access to prescription drugs, as well as the likely repercussions of the recently passed Medicare legislation on Medicare beneficiaries. We identified four dimensions of access: availability, coverage, equity, and flexibility. We examined a fifth item, transparency, unrelated to access but relevant to the formulary decision-making process as a whole. Study Design and Methods: Drawing from public data from the US and Dutch drug regulatory agencies, three leading US managed care plans participating in the Medicare Advantage program, Michigan's Medicaid agency, and the Dutch board of insurers, we determined for the period 1991–2004 (1) which cardiovascular drugs were approved for marketing in the United States and the Netherlands and approval dates; (2) formulary status of the approved drugs; and (3) copayments for on-formulary drugs. For each in...