Who Should Attend
This two-day training course is designed for personnel responsible for patient recruitment in the Pharmaceutical, Biotechnology, Device and Biologics industries as well as Clinical Trial Site personnel. Attendees who need to understand the development processes for drugs, devices and biologics along with methods to improve the identification of eligible patients for clinical trials and maximize their participation in studies will greatly benefit from this training.
The course will especially useful for Clinical Trial Project Managers, Clinical Research Associates, Principal Investigators, Study Coordinators, and other personnel responsible for patient recruitment and retention.
Learning Objectives
Numerous factors can complicate the tasks of identifying eligible subjects for clinical trials and retaining those subjects until completion of the trial. The course will explore these variables in depth and discuss methods for overcoming these obstacles.
Participants will gain an understanding of the barriers to patient recruitment, and learn novel concepts in reaching patient populations, including diverse populations, as well as strategies within ICH guidelines to maximize retention of eligible subjects. Pharmaceutical or CRO Project Managers and Clinical Research Associates will discover how to use models to predict recruitment rates, validate site enrollment potential more realistically, and how to place studies with Investigators in areas that are most likely to yield the best recruitment. Investigative site personnel will learn unique strategies to reach out to potential subjects and partner with sponsors to maximize patient completion in studies.
Course Description
This interactive course will contain a balance of theory and practical strategies that will prove extremely effective in maximizing patient recruitment and retention in clinical trials. Attendees will gain a definite competitive advantage in the industry.
The course will examine barriers to patient recruitment and retention and present proven strategies to address those issues. Special emphasis will be placed on looking at barriers from a patient’s perspective. Techniques for identifying high-enrolling, high-quality sites prior to the study start-up will be discussed. The course will demonstrate the effective use of epidemiologic data and protocol details to establish a realistic risk plan and a good data-driven site selection strategy in order to assist with meeting timelines and other business deliverables. Upon completion of this course, participants will be able to document a protocol and site specific recruitment and retention plan and understand the benefits of doing so.
This course is recommended in particular for individuals who foresee potential challenges with recruitment on a particular protocol or with a particular patient population. Pharmaceutical, Contract Research Organization (CRO) and Biotechnology representatives will learn how to best partner with site staff to recruit and retain patients for clinical trials. Site staff will be better informed of the barriers patients face when deciding whether to participate in clinical trials. Consequently, site staff will be able to provide sponsors with written plans and sound data to request the support necessary to maximize their sites enrollment.
The following issues will be discussed as they relate to patient recruitment and retention:
- Sponsor / CRO responsibilities
- Choosing participating sites
- Site responsibilities
- Barriers to recruitment and retention
- Diversity
- Maximizing partnership between sponsor/CRO and sites
- Written recruitment plans
- External resources
- FDA and EMA (Europe) based interactions with CROs
Participants will understand:
- The pitfalls of the current site selection process and rationale for using data driven site selection
- How to better predict enrollment and retention rates
- How to mitigate enrollment and retention challenges
- How to maximize the sponsor / CRO and site partnership
- Why documented recruitment plans are necessary
- What resources are available