Carl L Roland and Paul Litka

Introduction 178

Clinical Trial Conduct 181

Contract Research Organizations (CROs) 193

Selected Issues in Clinical Development 197

Summary 200

References 200

This chapter focuses on the activities and operations related to the conduct of clinical trials for new product development, applicable to both U.S. and non-U.S. trials as well. Although the focus of this chapter is on the development of new drugs (including biologics), many of the principles are also applicable to medical device development. Note, however, that while similarities in principle exist, device development is governed by separate U.S. federal regulations. Clinical trial operations are based on good clinical practices, best possible science, use of technology, best business practices, optimal management principles, people with expertise and interpersonal skills, the regulations and laws from governing agencies, and some good common sense. These eight areas, that is, skills and attributes, will be brought into the discussions in this chapter to best elaborate upon operations for clinical trials.

As described previously in Chapters 1-3, the development of a new product is complex, costly, and time-consuming. Therefore, effective planning is necessary. The proper conduct of the clinical trials required by the development plan is critical to the overall process of developing a new drug. This chapter will provide the reader with a broad understanding of what is required to conduct a clinical trial including the responsibilities of those working in the area of clinical operations, the major systems and processes, key outcomes, and relationships between the sponsoring company and the inves-tigator(s), often at universities. Contract research organizations (CROs) can and do perform many of the roles and responsibilities of clinical research on behalf of a sponsoring company; they also are discussed. What and how the work is done in collaboration between a CRO and a manufacturer is addressed. Finally, a series of selected issues and controversies in clinical research in the industry are addressed.

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