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biomedical-market-news.com_0008 - 2005-05-05 tufts.edu - sacserv.com/links.jsp mailto:peg.hewitt@tufts.edu 617-636-2185
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Subject: BMN PRESS REE-mailNewsService<biomednews@aol.com>LEASE: No. of
Principal Investigators in US is Declining, Says Tufts Ctr for Study of
Drug Development
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BMN PRESS RELEASE
Contact: Peg Hewitt
Tufts Center for the Study of Drug Development
617-636-2185 phone
peg.hewitt@tufts.edu

NUMBER OF PRINCIPAL INVESTIGATORS IN THE US IS DECLINING, ACCORDING TO TUFTS CENTER FOR THE STUDY OF DRUG DEVELOPMENT
-- Continuation of the trend could "pose several threats" to drug companies
http://sacserv.com/links.jsp?linkid770&subid412705&campid1592&type=0

BOSTON MA USA -- MEDICAL INDUSTRY E-MAIL NEWS SERVICE(TM) -- MAY 04 2005 -- Following steady growth through the 1990s, the number of principal investigators conducting industry-sponsored clinical studies in the US has declined 11% since 2001, claims a new study recently completed by the Tufts Center for the Study of Drug Development.

The drop in principal investigators has been spurred by a similar decline in the number of active clinical trials, the study found.

According to Tufts CSDD, a 10.6% decline in clinical trials has led to an 11.4% drop in total principal investigators in the US between 2001 and 2003.

The study, the first of its kind to assess the principal investigator landscape, also found that turnover rates among principal investigators in the US have nearly doubled since 2001. In comparison, regional and gender disparities among principal investigators have grown.

Tufts CSDD conducted extensive analyses of a database of over 100,000 principal investigators who registered with the US Food & Drug Administration to conduct clinical trials of investigational drugs between 1977 and 2004.

CAPACITY TO CONDUCT CLINICAL TRIALS IS ERODING:

"The decline in the number of principal investigators and the high turnover rate pose several threats to research sponsors," noted Ken Getz, research fellow at Tufts CSDD and author of the study.

"The capacity of the market to conduct clinical trials for industry sponsors is eroding. Efforts to establish a well-trained, experienced pool of clinical investigators may become more difficult."

Growing gender & regional disparities:

In addition, he said, growing gender and regional disparities among principal investigators will limit professional opportunities, and potentially diminish scientific and economic benefits to declining regions. "This, in turn, could make it more difficult to recruit representative patient populations," said Getz.

Commenting on the significance of the study's findings, Tufts CSDD Director Kenneth I Kaitin said, "As the time, cost and risk of new product development increases, pharmaceutical and biotech companies are looking to identify bottlenecks and improve efficiency of every facet of drug development. We believe this study will help them assess and improve their management of investigative sites."

FINDINGS:

The Tufts Center's analysis, summarized in the just-published May/June Tufts CSDD Impact Report, also found that:

-- While the total number of principal investigators in the US decreased from 2001 to 2003, their counterparts outside the US increased by 8%.

-- By 2000, half of all principal investigators in the US chose never to conduct another clinical trial - nearly double the turnover rate observed 10 years before.

-- The proportion of female-to-male principal investigators in the US is steadily declining, and is significantly below the overall ratio of female-to-male board certified physicians.

-- Only 3% of all board certified physicians are principal investigators, and a growing percentage of principal investigators are migrating to the South region of the US

TUFTS CSDD IMPACT REPORTS:

For more information on the Tufts CSDD Impact Reports - a bimonthly publication presenting original analyses and insights on a host of mission-critical issues relating to the nature and pace of drug development, visit:

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TO SUBSCRIBE TO THE TUFTS CSDD IMPACT REPORTS, VISIT:

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ABOUT THE TUFTS CENTER FOR THE STUDY OF DRUG DEVELOPMENT:

The Tufts Center for the Study of Drug Development at Tufts University provides strategic information to help drug developers, regulators and policy makers improve the quality and efficiency of pharmaceutical development, review and utilization.

http://sacserv.com/links.jsp?linkid773&subid412705&campid1592&type=0

The Tufts Center, based in Boston, conducts a wide range of in-depth analyses on pharmaceutical issues. The Tufts Center hosts symposia, workshops and public forums on related topics. It also publishes the Tufts CSDD Impact Report, a bimonthly newsletter providing analysis and insight into critical drug development issues.

FOR FURTHER INFORMATION, PLEASE EMAIL TUFTS CSDD AT:

csdd@tufts.edu

Peg Hewitt
Tufts Center for the Study of Drug Development
Tufts University
192 South St Ste 550
Boston MA USA 02111
617-636-2185 phone
617-636-2425 fax
peg.hewitt@tufts.edu
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