Background

Clinical trial data on the safety/risk profile of a drug is not generalizable to the all patients who will be using the product. A real-world knowledge gap exists at the time of drug approval. Frequently, post-marketing commitments/requirements (PMC/PMR) or post-approval safety studies (PASS) are conducted to address this void. Registries are an effective means of obtaining this vital safety data through an observational study design. While registries are relatively straightforward to conduct, they can be costly and take many years to meet enrollment goals and accrue sufficient evidence to meet study objectives. A multi-sponsor registry is a collaborative endeavor in which multiple stakeholders work together to meet common study goals. Multi-sponsor registries provide a solution which can expedite the accrual of patient safety data needed to inform patients and healthcare providers in a timely manner. This operationally efficient approach can reduce costs for participating sponsors; however, a strong organizational structure is needed to ensure success.

Overview

In this webinar, we will discuss considerations for multi-sponsor registries from a variety of stakeholder perspectives: manufacturer/sponsor, CRO, patients/healthcare providers.

The objectives are to:

Differentiate various organizational structures used in registries, including single-sponsor/ single-product, single-sponsor/multi-product, and multi-sponsor/multi-product
Examine the appropriate use of each type
Discuss advantages and challenges from scientific, operational, analytical, regulatory, manufacturer, and advisory points of view
Highlight operational best practices in the context of a detailed case study

Case Study:

The Antiretroviral Pregnancy Registry (APR) is perhaps the best example of a collaborative, multi-sponsor registry, bringing together more than 25 independent manufacturers of 45+ products (branded drugs and generic equivalents). Since 1989, the APR has enrolled greater than 20,000 prospective antiretroviral-exposed pregnant women. Voluntarily initiated, the APR evaluates the safety of antiretroviral (ARV) drugs used in pregnancy and fulfills FDA post-marketing commitments/requirements for ARVs marketed in the U.S. for the treatment and prevention of HIV.

Upon completion of this webinar, the attendee should be able to:

Discuss multi-sponsor registries and how they differ from other types of registries
Identify situations in which a multi-sponsor registry should be considered
Summarize the advantages and challenges of implementing and conducting a multi-sponsor registry
Discuss methodological and analytical considerations of multi-sponsor registries
Explain strategies for safe-guarding confidential and proprietary company information in the collaborative research setting

Keywords:

CRO
Registries

Speakers

Bill Row, MBA, MS, Vice President, Late Phase, INC Research

Bill Row interacts with senior management, customers, business development, and project teams to coordinate Late Phase Operations providing strategic direction, scientific consulting, and executive oversight. Mr. Row is a recognized leader in the design, operational strategy, and commercial applications of late phase studies with nearly two decades experience at both Pharma and CRO. He has held leadership roles in Clinical Operations, Project Management, and Strategy/Innovation spanning all phases of clinical development. Over the last 10 years, Mr. Row has held Executive Management roles exclusively in the Late Phase, real-world research environment with expertise in strategy and implementation of non-interventional, epidemiological, outcomes, HEOR, peri-approval, and market access programs.

According to Bill, “Late Phase and real-world research is extremely complex and requires a great deal of experience to get it right. We’re working with sponsors, regulatory authorities, health care providers, and patients to provide insight into key drivers of disease, treatment and safety measures that exist in the general population. Application of real world evidence has applications across all phases of development, and the stakeholders are demanding more of this insight at every stage of development. I am passionate about collaborating with our customers to provide the most cutting edge, efficient, fit-for-purpose approach to real world data generation.”

Mr. Row holds a BA in Experimental Psychology from Purdue University, a MBA from Xavier University, and a MS in Pharmaceutical Science from the University of Cincinnati. He is located at INC Corporate Headquarters in Raleigh, North Carolina, USA.

Message Presenter

Dr. Jessica Albano, PhD, MPH, Senior Director, Epidemiology, INC Research

Dr. Albano has more than eight years experience in a clinical research organization (CRO) as an epidemiologist with Phase IV and observational/non-interventional studies. Jessica Albano also has 5 years experience as an epidemiologist with the American Cancer Society and conducting research in an academic setting. Her areas of expertise include design and implementation of observational epidemiologic studies, statistical analysis and results interpretation, conducting literature reviews, and authoring publications. Additional skills include the application of surveillance data from public use data bases including census and vital statistics data and medical claims data to study design, feasibility, and aggregate safety reports.

She has served as Principle Investigator providing scientific oversight for a number of longitudinal observational studies and has been an invited speaker at the NIH on global patient registries and the FDA on pregnancy exposure registries. She actively participates with the International Society of Pharmacoepidemiology (ISPE) and the International Society of Pharmacoeconomics and Outcomes Research (ISPOR).

Message Presenter

Dr. Susan Sinclair, PhD, MPH, Associate Professor, UNCW College of Health and Human Services, and Sr. Advisor, INC Research

Dr. Sinclair is an epidemiologist with 25 years of experience in public health epidemiology and pharmacoepidemiology with a primary focus on medication safety during pregnancy and birth defects. Dr. Sinclair has participated in numerous observational studies and clinical trials over the past 17 years and is currently an associate professor at the University of North Carolina Wilmington. She worked in several roles in the clinical research industry at another CRO (1998-2004) and INC Research (2004-2006); and has served as a Senior Advisor to INC Research for 10 years (2006-present). Dr. Sinclair is a consultant to the Food and Drug Administration’s (FDA) Drug Safety and Risk Management Advisory Committee and has authored over 60 peer-reviewed published articles and abstracts. Dr. Sinclair was an Epidemic Intelligence Officer for the Centers for Disease Control and Prevention (CDC) from 1996 through 1998 and earned the rank of Lieutenant Commander in the US Public Health Service. Prior to completing her master’s and doctoral degrees in public health, she worked as a critical care nurse at Duke University Medical Center (Durham, NC) and Memorial Sloan Kettering Cancer Center (New York, NY).

Message Presenter

Who Should Attend?

Senior level professionals involved in clinical research or clinical trial data. Relevant job areas include:

Clinical operations
Operations management
Project management
Safety

Xtalks Partner

INC Research

INC Research (Nasdaq:INCR) is a leading global contract research organization (“CRO”) providing the full range of Phase I to Phase IV clinical development services for the bioPharmaceutical and medical device industries. Leveraging the breadth of our service offerings and the depth of our therapeutic expertise across multiple patient populations, INC Research connects customers, clinical research sites and patients to accelerate the delivery of new medicines to market. The Company was named “Best Contract Research Organization” in December 2015 by an independent panel for Scrip Intelligence, and ranked “Top CRO to Work With” among large global CROs in the 2015 CenterWatch Global Investigative Site Relationship Survey. INC Research is headquartered in Raleigh, NC, with operations across six continents and experience spanning more than 110 countries.