Eric Manheimer1, Diana Anderson. 1. Center for Clinical Trials and Evidence-based Healthcare, Brown University, 169 Angell Street, Providence, Rhode Island 02912, USA. Eric_Manheimer@brown.edu
Abstract
OBJECTIVE: To evaluate the completeness and accessibility of public information about US clinical trials of drugs in development. DESIGN: Review of online registers of clinical trials. DATA SOURCES: Drugs in phase III trials were identified using three drug industry sources: PhRMA Survey, What's in the Pipeline, and the NDA Pipeline. Drug trials were then searched for on the following publicly accessible registers of clinical trials:, and registers associated with the 37 "Comprehensive Cancer Centers" designated by the National Cancer Institute. MAIN OUTCOME MEASURE: Extent of availability of public information on phase III trials of drugs in development for treating either prostate or colon cancer. RESULTS: Search of industry sources identified 12 drugs for prostate cancer and 20 for colon cancer undergoing phase III trials. The most comprehensive publicly available register, contained trial listings for only seven of the prostate cancer drugs and 10 of the colon cancer drugs. Trials of three prostate cancer and three colon cancer drugs were listed on only one register each. A substantial proportion of trials of prostate cancer drugs (3/12) and colon cancer drugs (8/20) were not associated with trial listings in any registers. CONCLUSIONS: Existing trials registers are unlikely to be meeting user needs since many ongoing drug trials are not listed. There is a clear need for a comprehensive clinical trials register encompassing all ongoing trials, including industry sponsored trials.
OBJECTIVE: To evaluate the completeness and accessibility of public information about US clinical trials of drugs in development. DESIGN: Review of online registers of clinical trials. DATA SOURCES: Drugs in phase III trials were identified using three drug industry sources: PhRMA Survey, What's in the Pipeline, and the NDA Pipeline. Drug trials were then searched for on the following publicly accessible registers of clinical trials:, and registers associated with the 37 "Comprehensive Cancer Centers" designated by the National Cancer Institute. MAIN OUTCOME MEASURE: Extent of availability of public information on phase III trials of drugs in development for treating either prostate or colon cancer. RESULTS: Search of industry sources identified 12 drugs for prostate cancer and 20 for colon cancer undergoing phase III trials. The most comprehensive publicly available register, contained trial listings for only seven of the prostate cancer drugs and 10 of the colon cancer drugs. Trials of three prostate cancer and three colon cancer drugs were listed on only one register each. A substantial proportion of trials of prostate cancer drugs (3/12) and colon cancer drugs (8/20) were not associated with trial listings in any registers. CONCLUSIONS: Existing trials registers are unlikely to be meeting user needs since many ongoing drug trials are not listed. There is a clear need for a comprehensive clinical trials register encompassing all ongoing trials, including industry sponsored trials.
Entities:
Keywords:
Biomedical and Behavioral Research; Empirical Approach
Authors: Kay Dickersin; Eric Manheimer; Susan Wieland; Karen A Robinson; Carol Lefebvre; Steve McDonald Journal: Eval Health Prof Date: 2002-03 Impact factor: 2.651