Introduction to Improving Clinical Trials: Contemporary Design Solutions Including Endpoints, Surrogate Comparators, Pro
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INTRODUCTION TO IMPROVING CLINICAL TRIALS: CONTEMPORARY DESIGN SOLUTIONS INCLUDING ENDPOINTS, SURROGATE COMPARATORS, PROJECT PLANNING, AND COMPUTER-ASSISTED TRIAL DESIGN (CATD) CAMILLA M. OLSON Asset Management, Palo Alto. California
DAVIDSHAPIRO Covalent Group, Ldolla, California
The DIA Workshop “Improving Clinical Trials: Contemporary Design Solutions Including Endpoints, Surrogate Comparators, Project Planning, and Computer-Assisted Trial Design (CATD)” was held on October 27-28, 1997 in Philadelphia, Pennsylvania to review experiences in and to offer realistic solutions to improving the clinical development process that many groups could implement. Topicsfrom program goals to execution were discussed. This issue of the Drug Information Journal includes several papers from this successful symposium. They cover placebo-controlled trials, product management, computer modeling, and orphan drugs. Key Words: Clinical trials; Design; Endpoints; Surrogate comparators; Project planning; Computer-assisted trial design
IMPROVING THE CLINICAL development process to speed products to market with greater confidence of success and at a smaller cost is a frequently espoused goal. The realities of product development are more difficult that the platitudes suggest. The DIA Workshop “Improving Clinical Trials: Contemporary Design Solutions Including Endpoints, Surrogate Comparators, Project Planning, and Computer-Assisted Trial
Reprint address: Camilla M. Olson, Asset Management. 2275 East Bayshore Road, Suite 150, Palo Alto, CA 94303.
Design (CATD)” was held to review experiences and to offer realistic solutions that many groups could implement. Topics from program goals to execution were discussed. This supplement includes several papers from this successful symposium.
PLACEBO CONTROLLED TRIALS “Placebo Use” by Susan Ellenberg, PhD, and Robert Temple, MD, both of the Food and Drug Administration (FDA), presents a review of contemporary issues in the use of placebos in clinical trials. While some have suggested that placebo use may be unethical
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Camilla M. Olson and David Shapiro
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in all circumstances, Drs. Ellenberg and Temple argue that this is not the case and show ways in which placebos can be valuable in the clinical trial process and can be ethically and rationally used.
PRODUCT MANAGEMENT Small companies have pressures to get into Phase I11 quickly. Bobby Sandage, PhD, of Interneuron Pharmaceuticals discusses ways in which combined Phase I1 and I11 clinical trial designs can be used to speed drug development.
COMPUTER MODELING The use of computer modeling has become widespread in many industries yet has not been widely adopted by product developers. Two papers give an excellent perspective on this intriguing tool. While in its early stages, it seems likely that this technique is making product developers think about the interrela-
tionships of the parameters
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