Managing Investigator Initiated Clinical Trials: Structure, Process and Strategy (PH81)

Use this report to establish a dedicated IIT management department in your company. IIT department structure analyses and case studies will help you find the right format for your company's specific needs. Benchmark data, challenges and pitfalls, and break-through practices will help your company master the IIT proposal receipt process, IIT concept evaluation, study tracking, and IIT oversight. Three of the report's seven chapters are step-by-step guides dedicated to helping you achieve excellence in three key areas:

Building an IIT department from initial concept to full strategic integration

Using IIT study results to meet clinical, medical and commercial strategic objectives

Establishing performance measures to facilitate continuous process improvement

For years, companies supported investigator initiated clinical trials, also referred to as investigator sponsored studies or trials, with grant funding and drug supplies. But, they did so with little, if any, centralized oversight of operations. This led to a common practice of "idea shopping," in which persistent MSLs and sales reps pursued funding and support for their target physicians' IIT concepts in all corners of the company until they found someone with a budget willing to support the research. "Idea shopping" still happens today in companies that do not have centralized resources and processes in place to manage IIT oversight. These companies experience a costly gap in internal knowledge of ongoing IITs -- to the extent that study results are published, in some cases, without project or brand teams being aware that investigators were even conducting research on their drugs. Others have been "burned" by poor or lacking IIT management when investigators' trials competed with internal research teams for the same patients, or IIT study results yielded undesirable data.

This report examines the brief history of the inception of formalized, centralized, structured IIT management within the drug industry. It focuses primarily on current practices in IIT department structures and budgeting; IIT proposal receipt, evaluation and study management; and strategic integration of study results. Finally, it provides readers with industry executives' projections for the future of investigator sponsored research and the importance of the departments that manage it.

Published 2006

158 Pages

200+ Metrics

40 Charts and Diagrams

Format PDF

Table of Contents
Price: $7,695.00 / GBP3,847.50