Best Practice Approaches in Executing Post Approval Programs

Late phase research is an increasingly critical component of the overall drug development plan. But post approval studies, often referred to simply as “Phase IV”, fall into a broad spectrum of research types, requiring different approaches to study execution. This webinar will demonstrate best practices for post approval research, review the differences between interventional and non-interventional studies (NIS) and examine the reasons for various operational strategies.

Phase IV programs share many of the same requirements of their Phase 1-3 brethren, but the methodologies can be quite different. For example, study initiation is often completed in waves rather than all at once as countries gain marketing authorization. For large scale studies, the scientific rationale is well characterized and broadly published, so there are reduced training requirements; thus many sites can be easily trained together via interactive web-based sessions instead of face-to-face meetings that require travel and time away from the clinic. Sites can be selected for participation with broad mailshots instead of via traditional feasibility questionnaires. Lengthy negotiation of investigator fees can often be entirely negated with a standardized agreement and budget, and a “take it or leave it” approach. EDC applications are designed with simplicity in mind. And informed consent, still a critical component for late phase research subjects, is generally performed under scaled down templates and SOPs.

Perhaps one of the most important considerations for post approval programs is the type and level of site monitoring required in order to collect data and maintain quality. Interventional studies will still require some level of on-site monitoring, but this may involve reduced source verification, targeted review or a risk-based approach. Non-interventional studies may be monitored entirely remotely, or via predefined triggers. The monitoring plan represents a significant area of cost containment for Sponsor organizations, compared to earlier Phase research.

In this session, specific case study examples will be used to explore all these key topics. Learn best practices for site selection, including the possible need to over recruit sites for Phase IV trials. Gain an understanding of how to expedite the “green light” process given that there will be no investigational product. Understand how to work with Sponsor affiliates to maximize local engagement. Utilize cloud computing and patient reported data for streamlined data collection and reporting. Select a monitoring strategy that is cost effective and still quality-centric.

Best practices within post-approval research is a wide ranging area and there is much to consider. There is certainly no “one size fits all” and each study needs to be reviewed to see which strategies are right for each study. By the end of this webinar, the audience will have a better appreciation of the uniqueness of post approval research and will come away with some ideas to apply in their own programs.

Speaker

Alexandra Adams, Ph.D Dip.Clin.Sci. Hon FICR, Director, Late Phase, Chiltern

Alexandra (Alex) Adams is the Director of Late Phase, Europe for Chiltern International. In this role she leads the European post approval research function of Chiltern. Alex has more than 25 years of experience in the Pharmaceutical industry having worked in pharma, biotech, consulting, healthcare and the CRO environment. Around half her career has been spent in post-approval research and she was a founder member of the late phase function at a leading CRO. Alex has experience in many aspects of post-approval research from interventional phase IIIb/ IV to completely remote observational studies.

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