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 first biopharmaceuticals approved in the united states: 1980-1994

Abstract: Over the last 15 years, the United States biotech industry has developed innovative biopharmaceuticals through clinical application of recent technical advances in molecular biology. In an effort t...

Trends in the development and approval of monoclonal antibodies for viral infections.

Abstract: Monoclonal antibodies (mAbs) developed for either the prevention or treatment of viral diseases represent a small, but valuable, class of products. Since 1985, commercial firms have initiated clinical studies involving a total of 28 mAbs. To date, one product (palivizumab) has been approved and eight candidates are currently in clinical study. Most commercial mAbs studied as antiviral agents in the clinic have either directly or indirectly targeted human immunodeficiency virus, respiratory syncytial virus, or hepatitis C virus infections. However, the ability of mAbs to bind to specific targets and utilize various anti-infective modes of action would seem to make them well suited for the prevention and/or treatment of a wider variety of viral diseases. A number of factors, including the continuing need for innovative medicines for viral infections, the global spread of viral infections, and increased government funding for the study of pathogen countermeasures, have prompted companies to reconsider mAbs as antiviral agents. Public sector research into the use of mAbs against emerging pathogens, such as severe acute respiratory syndrome coronavirus, may have already provided candidates for further development.

A New Look At United States Drug Development and Approval Times.

Abstract: Clinical development and regulatory approval times for new chemical entities (NCEs) approved in the United States through 1995 were analyzed by both year of new drug application (NDA) approval and year of NDA submission. Results and conclusions from a recent General Accounting Office (GAO) report on US new drug approval times by year of NDA submission for NDAs submitted during 1987 to 1992 were examined and the analysis was extended using data collected by the Tufts Center for the Study of Drug Development (CSDD). The hypothesis that approval times declined by year of NDA submission for 1987 to 1992 submissions, independent of such factors as the therapeutic type and significance of the drugs reviewed, is not supported by the evidence. Mean times from first testing in humans, investigational new drug application (IND) filing, and initiation of Phase III testing to NDA submission increased over time for NCEs by period of NDA submission. When analyzed by year of approval, mean approval times for the 1994 and 1995 NCE approvals were markedly lower than mean approval times for previous years (1.7 y for 1994--1995 compared to 2.7 years for 1990--1993). Mean time from IND filing to NDA submission, however, was notably longer for the 1994 and 1995 approvals than for approvals in earlier years (7.2 y for 1994--1995 compared to 5.5 y for 1990--1993).

Variability in Protocol Design Complexity by Phase and Therapeutic Area

Abstract: The Tufts Center for the Study of Drug Development analyzed 8,317 clinical trial protocols to benchmark protocol complexity by phase and therapeutic area and to characterize trends in clinical trial complexity and the burden placed on study staff to execute protocol procedures between 2000 and 2007. Wide variability in protocol complexity and work burden was observed across therapeutic areas, within and between clinical research phases. Phase 1 protocols are the most complex and the most demanding to execute. The mean number of total procedures per protocol in phase 4 studies and the work burden associated with phase 1 protocols grew the fastest between the periods 2000-2003 and 2004–2007. The complexity and work burden of phase 3 protocols also grew rapidly during this period. Protocols in anti-infectives, immunomodulation, CNS, and oncology are consistently the most complex and burdensome to execute. Reasons for the wide variability in protocol complexity and work burden by phase and therapeutic area are discussed. This study provides insight into areas where protocol design improvements should be targeted.