Enrollment Is Open, But We Have No Drug! Making Lemons into Lemonade

Clinical Trials, Life Sciences, Pharma Manufacturing and Supply Chain, Pharmaceutical Regulation ,
  • May 14, 2015

When a sponsor company announced during the investigator’s meeting that manufacturing had been suspended and there was no drug available to begin enrollment the next day as planned, a Phase 2 respiratory study could have been completely lost. Sites had been preparing for weeks to gain IRB approvals and line up their COPD patients. But with quick thinking and careful use of the extra time, previously unplanned efforts toward motivating site staff and preparing them for enrollment allowed the study team to build significant momentum and excitement with astounding results.

Through active efforts by CRAs, provision of new tools to aid in patient recruitment, pre-screening and pre-scheduling visits and frequent transparent communication, enrollment was completed in a tenth of the expected time despite a 12 week delay to start. This compelling case study demonstrates how active techniques toward planning recruitment, even in the worst of circumstances, can save a study from near-certain catastrophe.

Patient recruitment is a frequently discussed topic in clinical trial circles. Despite countless industry efforts to improve efficiency in the planning and execution of clinical trials, as much as 80 percent of studies are delayed in their completion by a third or more of their intended durations. And enrollment, or lack thereof, is often the cause. These delays have major financial and clinical implications with the loss of potential revenue for drug developers, and delays to treatment for patients seeking new therapies. Those engaged in conducting clinical trials are always seeking new ways to improve patient recruitment outcomes.

This webinar will discuss the specific techniques used in order to accelerate subject recruitment. A case will be presented for working closely in partnership among the sponsor, CRO and sites; which all want the same outcome. Proactive recruitment planning needs to be a part of the strategy for every clinical program. Lessons from emergency situations like this – to build momentum and motivation – and the techniques employed are universally applicable.

Speakers

Barry Simms, Senior Executive Director, Clinical Monitoring, Chiltern

Barry Simms, Chiltern’s Senior Executive Director of Clinical Monitoring Operations, has 15 years of medical industry experience including over 13 years in clinical research across operations, business development, and executive roles. At Chiltern, Barry has held roles as a Clinical Trial Administrator, In-house CRA, Clinical Research Associate, Corporate Training Manager, CRA Trainer, several Business Development roles and North American Country Manager. Barry currently leads and mentors the entire CRA group for North America. He is closely engaged in client relationships and operational delivery with particular expertise in respiratory studies. Barry has a BS Degree from UVA at Wise, an MBA at King University, held a Clinical Research Associate Certification from ACRP for 10 years and has served on the Executive Steering Committee for PharmaTimes for the past three years.

Amanda Wright, Senior Director of Client Services, PMG Research

Amanda Wright joined PMG Research in 1998 as a Clinical Research Coordinator and has since served in various clinical operations capacities within the Winston-Salem research site and the PMG Research network support team. In 2008, she transitioned to lead business development efforts for the network, focusing on the cultivation of relationships with Sponsor and CRO partners to further PMG Research in achieving its mission to bring clinical research to as many lives as possible. She is currently Senior Director of Client Services, leading the teams within PMG Research responsible for business development, client services, feasibility, communications, and patient engagement and recruitment. Amanda was responsible for the first formal patient recruitment team at PMG Research in the early 2000s, and is currently leading teams charged with developing new strategies and processes for the centralization of feasibility, patient recruitment, and patient engagement across the PMG network in order to provide Sponsor and CRO partners with high-value services beyond the traditional research site model while delivering an exceptional experience to participants. Amanda holds a life sciences degree from the University of North Carolina – Chapel Hill and is currently participating in the President’s Club at the Sandler Institute.

Who Should Attend?

  • Directors of Outsourcing / Procurement / Project Management / Study Management / Clinical Operations
  • Investigators and study coordinators
  • Respiratory (COPD) clinical researchers

Xtalks Partners

Chiltern

Chiltern is a leading global CRO that listens to client needs in order to customize solutions for the Biopharma industry. With 33 years in service, Chiltern delivers from three specialized business units: Chiltern Biopharma, with deep therapeutic expertise for respiratory, anti-infectives / vaccines, ophthalmology, dermatology and other specialty areas; Chiltern Oncology, led by physicians, scientists and clinicians to uniquely manage all phases of hematologic and oncologic clinical drug development; and Chiltern Source, a world leader in tailored relationships for FSP, resourcing and staffing solutions. Chiltern’s 2,200 engaged professionals work across 45 countries to deliver flexible, responsive solutions that are “Designed Around You”.

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