CONFERENCE SERIES: Clinical Trials & Translational Medicine
Recorded at: Summit for Clinical Ops Executives (SCOPE)
Digital Course: Designing and Implementing a Clinical Enrollment Plan
Digital Course: Designing and Implementing a Clinical Enrollment Plan
March 8, 2010
CHI’s Summit for Clinical Ops Executives (SCOPE) is made up of four annual conferences and short courses. By bringing these four events and three short courses together under the SCOPE umbrella, an opportunity for idea sharing and cross pollination amongst clinical operations professionals from different groups was created. Each conference remains autonomous and goes deeply into its own set of issues with its expert faculty. Each conference will feature best practice case studies and interactive discussions relevant to clinical operations experts as well as those new to the field.
About the Conference:
CHI’s Third Annual “Patient Recruitment in Clinical Trials: Strategically Planning a Successful Recruitment and Retention Program” was held March 8-9, 2010 at the Crowne Plaza Philadelphia City Center in Philadelphia, PA. Patient recruitment and retention are critical to drug development programs. Patient recruitment if not adequately planned for can extend your development timeline by a number of years. Retention of patients throughout the life of a clinical trial is essential in order have complete data sets for your analysis and subsequent filings. In order to optimize both you have to have a plan. This conference is intended to cover the topics one should consider when drafting and strategically implementing a patient recruitment and retention plan for a clinical development program
Clinical Recruitment Planning Strategies: When is the Right Time to Plan, Implement, and Spend?
Manley Finch, MS, MPH, Vice President, Clinical Research, SleepMed, Inc.
Biography: Manley completed an undergraduate degree in Pre-Medical Sciences, and subsequently completed masters of science degrees in both Neuroscience and Clinical Research. He has recently completed a Masters in Public Health as Drexel University. Manley has an in-depth knowledge of the pharmaceutical industry and has been involved in all stages of pharmaceutical product development, project concept design and protocol development. Manley has authored over 32 clinical protocols and was the primary or sole author of 21 of them. Manley is an established expert in the patient recruitment strategies and is often an invited speaker in recruitment seminars. In addition, he brings a wealth of expertise in directing and managing all aspects of clinical trial implementation from concept development to database lock in multiple therapeutic areas. Manley has also recruited, organized, and monitored sites for Phase I through Phase IV studies for various CROs and Sponsors. Manley’s other strengths are a strong background in Medical Affairs, Marketing, Pharmacoeconomics, and Community Based Health Outcome Initiatives. He has established KOL contacts and collaborative research efforts in the fields of lipidemiology, cardiovascular disease, diabetes, metabolism, mental health, and psychiatry and has expertise in developing and establishing strong MSL and KOL outreach programs. He has robust contacts amongst the Native American societies within the USA and has conducted many health outcome and clinical research programs within their reservations and maintains an emic relationship with many tribal councils. His primary areas of expertise are Metabolic/Cardiovascular and Neurology/Mental Health. Expertise in metabolic/cardiovascular include diabetes (Type 1 and 2), diabetes complications, metabolic syndrome, insulin resistance, dyslipidemia, hyperlipidemia, and cardiovascular disease. Manley’s other area of expertise is in neurology/mental health; MS, Parkinson’s Disease, Neuro-Imaging, neuro-endocrinology, mood affect disorders, refractory depression, mood disorders/depression associated with diabetes, and CNS medication induced metabolic dysfunction. Manley’s areas of private research expertise and publications are cognitive impairment and mood affect disorders mediated by metabolic dysfunction, insulin resistance, and CNS medication side effects. Manley is currently the Executive Director of the HIV Nutrition Network, a not for profit HIV Advocacy Group working with people living with HIV/AIDS.
Patient Retention and Compliance Strategies
Helen West, Vice President, Strategic Development, MMG
Biography: Helen has 17 years of experience in clinical research, on both the study sponsor and service provider side. Her sponsor side responsibilities have spanned site, trial, program and clinical operations management in all phases of global trials across therapeutic areas. Achieving clinical trial efficiencies, particularly in patient recruitment, has been a consistent focus throughout her work. Helen has been recognized for her creative vision, which has resulted in the design and implementation of innovative solutions to complex clinical trial issues. At MMG, she contributes to the design of strategic global patient recruitment and retention programs and drives the development of enhanced and new capabilities to accelerate clinical trial completion.
Developing a Patient Recruitment Plan: Study Profiling, Strategy Development, Plan Implementation and Contingency Planning
Abbe Steel, Executive Director, United BioSource Corporation
Biography: Abbe has over 16 years of experience working in the pharmaceutical industry in the fields of patient education and compliance, clinical trial patient recruitment and retention, clinical and drug safety, and clinical trial management. Her responsibilities at UBC include designing study-related patient communication efforts related to patient recruitment and retention for clinical trials and registries, disease management, patient education and site-based enhancement strategies. She leads a team of clinical trial communication professionals all focused on designing and executing aggressive, multi-media initiatives to identify and enroll patients in trials and ensuring patient retention. Abbe utilizes her skills in marketing, advertising, public relations, medical education and call center activities to ensure our clients receive comprehensive patient recruitment and enrollment programs.
Prior to joining UBC, Abbe was Vice President of Worldwide Marketing and Operations for Galt Associates, an organization that offers drug safety and risk management services to the pharmaceutical industry. Prior to Galt, Ms Steel was Senior Director, Patient Programs at PAREXEL International. Abbe worked in PAREXEL’s Medical Marketing Services Division, a division of the company that executed Phase IV studies and registries. She was responsible for leading patient initiatives for trial recruitment and retention, disease management, patient education, and call center support programs. Abbe started her career at Sanofi Pharmaceuticals in the Corporate Relations Division supporting patient compliance and product marketing initiatives. Abbe received her B.A. from George Washington University.
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