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.

Evaluating the Impact of Patient Recruitment and Retention Practices

Abstract: The objectives of this study were to benchmark patient recruitment and retention practices across recently completed global clinical trials from a working group of biopharmaceutical companies. The data collection focused on recruitment and retention tactics used by companies as well as detailed information about the size and scope of the global trials conducted. In-depth organizational information regarding patient recruitment and retention structure and functions was collected. Despite numerous tactics available, participating companies indicated using a small number of patient recruitment and retention tactics. In addition, companies reported that 32% of studies did not implement any tactics. Traditional tactics were most widely used, including physician referrals (16%), newspaper advertisements (16%), and radio advertisements (13%). The relationship between use of recruitment tactics and enrollment data was explored and a positive association was found between use of nontraditional recruitment tactics and enrollment rates.

The New Drug Approvals of 1999, 2000, and 2001: Drug Development Trends a Decade after Passage of the Prescription Drug User Fee Act of 1992:

Abstract: This report is the sixth in a triennial series by the Tufts Center for the Study of Drug Development examining various aspects of recent new drug approvals in the United States. In 1999, 2000, and 2001 the U.S. Food and Drug Administration’s Center for Drug Evaluation and Research approved 86 new drugs, 82 of which met the Tufts Center for the Study of Drug Development’s definition of a new chemical entity (NCE). Of the 82, 34 (41%) received priority review, while 48 (59%) had standard review. The mean length of the clinical phase (Investigational New Drug Application [IND] filing to New Drug Application [NDA] submission) for the 82 NCEs was 5.5 years, and the mean approval phase (NDA submission to approval) was 1.4 years. Whereas the clinical phase represents a 14% decrease from that value for the previous three-year period, the approval phase remained unchanged. The mean approval phase for priority NCEs (0.9 years) was half that for standard NCEs (1.8 years). Of the 75 NCEs for which foreign marketing data were available, 51 % were first approved for marketing in the United States, while 27% were available in foreign markets one or more years prior to United States approval, with a mean of 6.5 years of prior foreign marketing. The percentage of products first approved in the United States represents a continuation of a trend since passage of the Prescription Drug User Fee Act of 1992 of drug sponsors seeking marketing approval in the United States prior to approval in other markets.

New challenges to medicare beneficiary access to mAbs

Abstract: Precision binding of monoclonal antibodies (mAbs) to biological targets, their relative clinical success, and expansion of indications following initial approval, are distinctive clinical features. The relatively high cost of mAbs, together with the absence of a regulatory pathway to generics, stand out as distinctive economic features. Based on both literature review and primary data collection we enumerated mAb original approvals, supplemental indications and off-label uses, assessed payer formulary management of mAbs, and determined new challenges to Medicare beneficiary access to mAbs. We found that the FDA has approved 22 mAbs and 30 supplemental indications pertaining to the originally approved mAbs. In addition, there are 46 off-label use citations in officially recognized pharmaceutical compendia. Across Part B carriers and Part D plans, we found considerable variation in terms of coverage and conditions of reimbursement related to on- and off-label uses of mAbs. Our results point to four major challenges facing mAb developers, health care providers, Medicare beneficiaries, payers and policymakers. These include administrative price controls, coverage variation, projected shift from physician- to self-administered mAbs, and comparative effectiveness. We suggest more systematic use of "coverage with evidence development" as a means of optimally addressing these challenges.