Preventing the Pitfalls in Planning Phase IV Clinical Trials: A Biotechnology Experience

Abstract

Postmarketing clinical trials are conducted with some important differences in the biotechnology industry versus the pharmaceutical industry. Most of these differences are related to the differences between biotechnology and pharmaceutical companies in size, management philosophy, structure, research orientation, and types of products. In biotechnology, more emphasis is placed on teamwork, open communication, and consensus building in planning and conducting Phase IV studies. Risk-taking and the willingness both to try different approaches and to change are cornerstones of biotechnology's philosophy of management. Rather than being the end of the line, product approval is a renewal of the product development process in the biotechnology industry. Because the products of biotechnology research often have a substantial impact on health care when they reach clinicians in the real world, it is essential that program planning emphasize involving end users, the practitioners who will be prescribing the products, as well as scientists at the company.