Masterarbeit

Defining the regulatory strategy for the rapid implementation of a multinational, global clinical trial in an oncological indication ***

Dr. Theodore L. Drell IV (2008)

Clinical trials are an essential and pivotal element of drug development. They are the means by which a new drug is demonstrated to be safe and effective, thereby also fulfilling the regulatory requirements which mandate this. The clinical development is expensive, but even more costly because of the time necessary to bring a new drug to market; each delay can cost up to million/day for a new potential blockbuster. The costs for research and development of a new substance are also on the rise. Thus, the regulatory strategy for the global development of a new drug must have the goal of obtaining clinical trial and marketing authorizations in the essential markets quickly, as cost-effective as possible while fulfilling the regulatory requirements. Developing and coordinating the regulatory strategy for multinational clinical trials in this setting is especially challenging.

Using the example of a simulated company and clinical development plan in an oncological indication, this work will have the focus of defining the regulatory strategy for a pivotal Phase III study in the clinical development program that optimizes time, resources and cost by incorporating scientific advice, paediatric development, guidelines, competitive intelligence, country selection/requirements, and risk assessment analyses. The regulatory and ethics committee requirements of the participating countries will be critically and comparatively elucidated. The regulatory strategy for the submission of IND/CTAs in these countries will be defined, to provide a prognostic timeline for approvals/positive opinions.

Last but by no means least, the risk assessment and analysis rounds out the regulatory strategy, by addressing the potential risks, assessing probability and seriousness, and suggesting preventative and contingency action for risk minimization. In an ever-changing regulatory and pharmaceutical environment, regulatory affairs must take a prominent role in communicating risk management strategies to the project groups and upper company management.

Pages: 49