Following steady growth through the 1990s, the number of principal investigators conducting industry-sponsored clinical studies in the United States has declined 11% since 2001, according to a study recently completed by the Tufts Center for the Study of Drug Development.
BOSTON - May 3, 2005 - Following steady growth through the 1990s, the number of principal investigators conducting industry-sponsored clinical studies in the United States has declined 11% since 2001, according to a 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 U.S. 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 U.S. have nearly doubled since 2001, while regional and gender disparities among principal investigators have grown.
Tufts CSDD conducted extensive analyses of a database of more than 100,000 principal investigators who registered with the U.S. Food and Drug Administration to conduct clinical trials of investigational drugs between 1977 and 2004.
"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 and efforts to establish a well trained, experienced pool of clinical investigators may become more difficult."
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."
The Tufts Center's analysis, summarized in the just-published May/June Tufts CSDD Impact Report, also found that:
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. The Tufts Center, based in Boston, conducts a wide range of in-depth analyses on pharmaceutical issues and hosts symposia, workshops, and public forums on related topics, and publishes the Tufts CSDD Impact Report, a bi-monthly newsletter providing analysis and insight into critical drug development issues.
Including Women of Childbearing Age in Clinical Research
March 26th 2024In recognition of International Women's Month, we're featuring this recent talk between Associate Editor Miranda Schmalfuhs and Marie Teil, Global Head of UCB’s Women of Childbearing Age Program. They speak about the specific challenges women with chronic illnesses face when accessing appropriate treatment and participating in clinical trials, UCB's Women of Childbearing Age Program and it’s most successful strategies, and much more.
Improving Engagement While Maintaining Data Integrity & Validity
March 19th 2024In recognition of Women's Health Month, we're featuring this recent talk between Associate Editor Miranda Schmalfuhs and uMotif's Chief Product Officer, Julia Lakeland, discuss new technologies improving patient engagement and reducing the emotional and logistical burdens of participation, ethical considerations that should be addressed when implementing those technologies, while ensuring patient privacy, and much more.
FDA Fast Tracks Johnson & Johnson’s Nipocalimab for Fetal Neonatal Alloimmune Thrombocytopenia
March 27th 2024Johnson & Johnson is moving forward with a pair of Phase III trials of nipocalimab to reduce the risk of fetal neonatal alloimmune thrombocytopenia in alloimmunized pregnant patients.