Pink Sheet is part of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC’s registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By



Executive Summary

CLINICAL TRIAL DESIGN TRENDS: COMPUTERIZED DATA BASES of drug use information will be useful for discovering potential new indications, but should not be viewed as a replacement for randomized clinical trials, FDA Office of Drug Evaluation I Director Robert Temple, MD, told a March 22 "Foresight Seminar." Temple said he "would hope" that linked computerized physician data bases of patient information "would be taken as hypothesis-generating systems, much as the intelligent physician observer is, and would not, at least without a lot more evidence," be taken as supportive evidence of an experimental use. The FDAer explained that while the trend of computerizing patient data at the physicians office could provide useful information about adverse experiences and new uses, such information cannot be controlled for bias, and therefore should be replicated with randomized trials. "When you're in control of the data base, as you always are in these kinds of trials, it's always possible for optimism and other kinds of biases to creep in," Temple said. Organized by the Institute of Alternative Futures, the seminar focused on new methodologies for clinical trials in the 1990's. Temple identified two trends in clinical trial design he sees for the next decade: larger trials measuring fewer clinical endpoints, and pooling of trial data. The advantage of a very large, yet simple, randomized trial "is that it allows one to look at effects of meaningful, but not very large, size that you simply can't look at in trials with only 1,000 patients," Temple said. The European community has been making use of very large, yet inexpensive, randomized trial designs for the last decade, Temple said, noting that "one interesting question is whether the same attitude can be brought to the U.S., because we have for the most part not been participating." The second trend, "the resurrection of pooling as a legitimate endeavor," will continue to grow in use because "the ways of doing that responsibly have been laid out," Temple commented. The institute's "Foresight Seminars" on pharmaceutical issues are sponsored by Ciba-Geigy, Glaxo, Merrell Dow, Pfizer, Sterling and Upjohn.

You may also be interested in...

Part D Discount Liability Coming Into Focus: CMS Releases Drug Cost Data

Newly released Medicare Part D data sheds light on the sales hit that branded pharmaceutical manufacturers will face when the coverage gap discount program gets under way in 2011

FDA Skin Infections Guidance Spurs Debate On Endpoint Relevance

FDA appears headed for a showdown with clinicians and the pharmaceutical industry over the proposed new clinical trial endpoints for acute bacterial skin and skin structure infections, the guidance's approach for justifying a non-inferiority margin and proposed changes in the types of patients that should be enrolled in trials

Shire Hopes To Sow Future Deals With $50M Venture Fund

Specialty drug maker Shire has quietly begun scouting deals with a brand-new $50 million venture fund, the latest of several in-house investment arms to launch with their parent company's pipelines, not profits, as the measure of their worth




Ask The Analyst

Please Note: You can also Click below Link for Ask the Analyst
Ask The Analyst

Your question has been successfully sent to the email address below and we will get back as soon as possible. my@email.address.

All fields are required.

Please make sure all fields are completed.

Please make sure you have filled out all fields

Please make sure you have filled out all fields

Please enter a valid e-mail address

Please enter a valid Phone Number

Ask your question to our analysts