TORONTO, ON--(Marketwired - November 01, 2016) - The presentation featuring a panel from INC Research including Bill Row, MBA, MS, Vice President of Late Phase, Dr. Jessica Albano, PhD, MPH, Senior Director of Epidemiology and Dr. Susan Sinclair, PhD, MPH, Senior Advisor (and Associate Professor at UNCW College of Health and Human Services), will discuss considerations for multi-sponsor registries from a variety of stakeholder perspectives: manufacturer/sponsor, CRO, patients/healthcare providers. The live event will take place on Thursday, November 17, 2016 at 10:30am EST (3:30pm GMT/UK).
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
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
To learn more about this event visit: Navigating Multi-Sponsor Registries: The Journey to Success
Xtalks, powered by Honeycomb Worldwide Inc., is a leading provider of educational webinars to the global Life Sciences community. Every year thousands of industry practitioners (from pharmaceutical & biotech companies, to private & academic research institutions, healthcare centers, etc.) turn to Xtalks for access to quality content. Xtalks helps Life Science professionals stay current with industry developments, trends and regulations. Xtalks webinars also provide perspectives on key issues from top industry thought leaders and service providers.
To learn more about Xtalks visit: http://xtalks.com
For information about hosting a webinar visit: http://xtalks.com/sponsorship.ashx
Image Available: http://www.marketwire.com/library/MwGo/2016/10/31/11G120234/Images/logo-1421394168669.jpg