Why Pharmacovigilance (Phase IV) Trials are Increasingly Seen: Why they are Important and what they tell us?

Duration: 75 Minutes
FDA-mandated post-market studies are here. Phase IV studies are likely to be complex in design and large in scale (possibly 500,000 patients per arm), with exacting endpoints, and obligatory. The FDA appears to be abandoning a long-standing policy of negotiating post-market commitments with sponsors - and will now set mandatory objectives and timelines.
FDA Phase IV trials
Product ID: 500162
There is no one-size-fits-all guidance to help a particular drug or drug class prepare for the studies. There are, however Guidance documents for “Risk Minimization Action Plans” and “Good Pharmacovigilance Practices and “Pharmacoepidemiologic Assessment” and there is also the ICH E2E Guidance of Pharmacovigilance Planning. The likelihood of Data Monitoring Committees being required is also expected to increase.

There are a number of points that are only seen in Phase IV (PV) studies and why these are important in the Drug Development process will be covered. These studies (and there are several types of Phase IV/Post Marketing studies) answer important safety questions and because of this and the duration of these studies, they are almost always associated with Data Monitoring Committees (DMC’s).

Why Should you Attend:
With the increasing complexity of therapeutic agents – now involving more “biologics” – and an increase of use of new agents beyond the original intention and testing, it is essential to know as early as possible any untoward and unexpected Adverse Events and other serious toxicities. The well known examples of Drugs pulled from the market after approval attest to the need for Phase IV (Post marketing approval) studies.

Objectives of the Presentation:
  • What are the types of Phase IV studies
  • The Nature of the I/E criteria in Phase IV studies
  • How does the Safety Monitoring Plan differ in Phase IV
  • What constitutes a “rare” adverse event?
  • Why large studies are needed to uncover rare Serious Adverse Events
  • What is the role and value of a DMC in large studies
  • What endpoints is the FDA looking for once they have approved a drug/device
Who can Benefit:
Those benefiting the most would be the Principal Investigators and sub investigators, Clinical Research Scientists (PKs, Biostatisticians,), Safety Nurses, Clinical Research Associates (CRAs) and Coordinators (CRCs), Recruiting staff, QA / QC auditors and staff, & Clinical Research Data managers In addition, the holders of the IND for new products i.e. the Sponsors will benefit.

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Instructor Profile:
Charles H Pierce is President of the virtual CRO Global Clinical Partners, Inc and Pierce One Consulting. From an original Master’s thesis (Pharmacology) in 1961 (Minnesota) through a Doctorate in Surgery-Pharmacology in 1974 (Saskatchewan) and continuing throughout 45+ years in the practice of clinical medicine as a family physician (7 years as an ER doc) and 25+ years in the medical research industry (7 years as a Principal Investigator), Charles has an experienced based knowledge of the Clinical Research part of Drug Development.

He is an APPI/APCR Certified Principal Investigator (CPI in 2003 and recertification’s to 2016). He is actively involved in Webinars, courses and workshops.

Charles’ active management experience in the medical research industry gives him first-hand practical experience and knowledge to develop Phase I, IIa confined study Clinical Pharmacology Units (CPU’s). Charles is a Fellow and Life Member of the American Academy of Family Physicians and Emeritus fellow of the American College of Clinical Pharmacology (ACCP) and the 2004 recipient of the Nathaniel Kwitt Distinguished Service Award. He is an active member of the Association of Clinical Pharmacology Units (ACPU). He is also a member of the Academy of Physicians in Clinical Research (APCR) and the 2012 Chair of the Board to trustees of the Academy of the Association of Clinical Research Professionals (ACRP).
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