Article type
Year
Abstract
Objective: To evaluate in a pilot study the current accessibility, completeness, clarity, and comprehensibility of publicly accessible information about ongoing clinical trials in the US.
Methods: We elected to limit our evaluation to US-based phase III trials of drugs in development for the treatment of prostate cancer. We selected available sources of information on 1) drugs in development and 2) ongoing trials. We consulted three pharmaceutical industry sources to identify names and descriptions of drugs in development: PhRMA Survey (May 1999), What's in the Pipeline (June 1999), and the NDA Pipeline (January 2000). To eliminate duplicate listings of the same drug, websites of the companies that develop the identified drugs were visited and drug name synonyms were catalogued. We assessed the following publicly accessible clinical trials registers for availability of trials of identified drugs: PDQ/CancerNet, CenterWatch, ClinicalTrials.gov, and the trials registers for the 37 US Comprehensive Cancer Centers. All registers were searched in March 2000 using either: a visual scan for trials listed under the heading 'prostate cancer,' the register's search dialogue box, or the browser's 'find in page' function. All possible permutations of a drug name were used to search for each drug.
Results: Thirteen prostate cancer drugs under development were identified. The most comprehensive register, ClinicalTrials.gov, contained trial listings for only seven of these. Four drugs were not associated with trial listings in any of the registers; three were associated with trials that were only listed on one register each. Individual trial listings often contained minimal information, and terms used for drugs and conditions were not standardized across the registers. Language used in many registers was highly technical. Searching for information on the registers was sometimes difficult.
Conclusions: There is a clear need for the construction of a comprehensive clinical trials register encompassing all ongoing clinical trials funded by pharmaceutical companies. The current mode of information dissemination is time-consuming and inefficient and is unlikely to be meeting the needs of users.
Methods: We elected to limit our evaluation to US-based phase III trials of drugs in development for the treatment of prostate cancer. We selected available sources of information on 1) drugs in development and 2) ongoing trials. We consulted three pharmaceutical industry sources to identify names and descriptions of drugs in development: PhRMA Survey (May 1999), What's in the Pipeline (June 1999), and the NDA Pipeline (January 2000). To eliminate duplicate listings of the same drug, websites of the companies that develop the identified drugs were visited and drug name synonyms were catalogued. We assessed the following publicly accessible clinical trials registers for availability of trials of identified drugs: PDQ/CancerNet, CenterWatch, ClinicalTrials.gov, and the trials registers for the 37 US Comprehensive Cancer Centers. All registers were searched in March 2000 using either: a visual scan for trials listed under the heading 'prostate cancer,' the register's search dialogue box, or the browser's 'find in page' function. All possible permutations of a drug name were used to search for each drug.
Results: Thirteen prostate cancer drugs under development were identified. The most comprehensive register, ClinicalTrials.gov, contained trial listings for only seven of these. Four drugs were not associated with trial listings in any of the registers; three were associated with trials that were only listed on one register each. Individual trial listings often contained minimal information, and terms used for drugs and conditions were not standardized across the registers. Language used in many registers was highly technical. Searching for information on the registers was sometimes difficult.
Conclusions: There is a clear need for the construction of a comprehensive clinical trials register encompassing all ongoing clinical trials funded by pharmaceutical companies. The current mode of information dissemination is time-consuming and inefficient and is unlikely to be meeting the needs of users.