44s Abstracts

s12 STANDARDIZED COMPUTER-BASED REPORTING OF CLINICAL

TRIALS: IN SUPPORT OF META-ANALYSIS

Ida Sim Stanford Medical School

Stanford, Carifornia

Performing a good meta-analysis is difficult, partly because clinical trial reports are often incomplete and inaccurate. With the advent of electronic publication, now is an opportune time to build an integrated, electronic, trial reporting system that will support improved, standardized trial reporting; improved retrieval of trial reports; and direct computer access to both descriptive and summary results data of trials. For such a system to be truly integrated, the electronic trial databanks, or Trial Banks, must all use a common conceptual model of clinical trials. This conceptual model should be able to represent information about the design, execution, and results of trials in any stage of execution, from planned to fully completed.

I have incorporated trial reporting recommendations from trial registries, structured trial reporting, and other clinical trial commentators into an initial conceptual model of randomized trials. The model consists of 156 concepts, which can be classified as being about population, treatment, outcomes, treatment allocation, statistics or administrative matters at the design, execution or results stage of randomized trials. I have implemented this model as a Filemaker Prom database. Preliminary use shows that the model has fully captured four randomized trials for the task of contingency table meta-analysis, as well as partially capturing four prospective cohort trials. Future work will include further refinement of the model, its implementation as a Web-based Trial Bank, and formal evaluation of the model’s expressivity and utility for meta-analysis.

Al3 EXPLORING THE INFORMATION SUPERHIGHWAY: USE OF THE INTERNET IN CLINICAL DRUG TRIALS

Sarah Carr, Vicky Foster, Matthew Wiener and Aimee Blagg

Pharmatech, Inc. Denver, Colorado

The biomedical product development industry has a need to reduce the “time to market” and the cost of product development. The rate limiting step for clinical trial completion can be the timely recruitment of subjects. This leads to the necessity for expanded and innovative subject recruitment procedures for the clinical trials. The Internet is a potential resource for subject enrollment. The Internet has over 35 million users in North America, 50 million worldwide, and is said to be the fastest growing information medium. The expansion of the Internet, and particularly the world wide web, into the public domain has led to its utilization for communication with a variety of stakeholders: subjects, investigators and sponsors. A “home page” , or a more complex world wide “website”, allows for the dissemination of general information, but also provides detailing depth contact via e-mail should a respondent request greater detail. Multiple hotlmks on websites give the interested “surfer” referral resources. Pharmatech has developed a website which includes information of biomedical research and specific trials (http://www.pharmatech.com). The initial month of operation reflected 15 visits a day, yielding 6 specific inquires daily. Pharmatech recently utilized