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Thursday, May 8, 2008
MAXIMIZATION OF PATIENT RECRUITMENT AND ENROLLMENT
8:00 Morning Coffee
8:30 Chairperson’s Remarks
8:30 Chairperson’s Remarks
8:40 Key Issues with Patient Recruitment Today
Diana L. Anderson, Ph.D., President and CEO, D. L. Anderson International, Inc.
9:10 Holistic Solution to Patient Recruitment
Jane Eisner, Senior Vice President, Global Access to Patients, Quintiles Limited
Quintiles has invested considerable resources developing solutions to patient recruitment with proven results. Patient recruitment is being solved through 2 approaches; 1) building a network of high performing investigator sites, 2) deploying data mining and patient outreach tactics holistically through sites and Clinical Research Associates. The industry has deployed a number of recruitment tactics and many vendors have been set up, but success has been limited due to the lack of a holistic approach. Investigator sites hold the key to timely patient recruitment in the short term and their buy in is essential for these tactics to work. Moreover building a high performing investigator network negates some of these site challenges.
9:40 The Benefits of Centralized Recruitment: Metrics and Case Studies
Donna Beasley, Vice President, Operations, Praxis Inc.
The objective of this presentation is to demonstrate how both sponsors and sites can benefit from using the latest technology for centralized recruitment campaigns to increase ROI, enroll the study on time, reduce the drug development cycle times and overall operational costs. This presentation will also demonstrate how a proactive strategy utilizing a combination of media tactics yields exponentially higher results. In addition, through the use of a centralized recruitment campaign, results can be tracked and monitored 24/7 to deliver more qualified patients, increase randomization rates and reduce overall costs and time needed to enroll the study.
10:10 Networking Refreshment Break and Exhibit Viewing
10:40 Technology Spotlight 
Solving Patient Recruitment Problems: Applying Focused Contingency Planning to Achieve Higher Assurance Toward Last Patient In and Make Effective Accrual Investments
Joshua Schultz, Vice President, Clinical Research Services, PAREXEL International
This session will help trial managers solve problems associated with patient recruitment through focused contingency planning. By applying sophisticated, layered and effective patient recruitment approaches, trial managers will be able to eliminate the volatility of missing last patient in targets, while achieving higher assurance toward last patient in deadlines and making more effective investments in patient recruitment programs.
11:10 Utilizing Field-Based Medical Personnel (MSLs) to Enhance Enrollment
Scott L. Traub, Pharm.D., Director, Urologics, Regional Scientific Services, Medical Affairs, Allergan, Inc.
There are many factors which impact patient recruitment into clinical trials. In part, these include how closely study procedures mirror clinical practice vs scientific rigor and agency requirements, how strict entry criteria are, burden/risks vs rewards/benefits to patients and study personnel, familiarity and comfort level of study staff with science behind the test article, and of course, availability/access to patients likely to be eligible and dedication of the principal investigator and study coordinator. Many of these factors are interdependent. Dedication to, enthusiasm about, and ability to convey the rationale, risks and benefits of the study in a proper perspective is associated with their knowledge of the drug candidate. Investigators brochures can provide this knowledge, but it is difficult to glean out the information therein important to the decision-making of the clinicians. Allergan has established a process whereby medical liaisons specially trained in the clinical development process and on study protocols and associated informed consents assist sites by furnishing pertinent medical science information and perspectives, and provide site-specific enrollment tactics. A positive impact has been determined based on enrollment-activity mapping and site surveys.
11:40 Panel Discussion
Case Studies - Leveraging Opted-In Patient Databases for Centralized Patient Recruitment
The objective of this panel is to introduce the concepts, benefits, challenges, and best practices of opted-in patient databases as a centralized patient recruitment strategy. This session will use a variety of recent case studies to illustrate the efficacy and challenges of patient databases for centralized recruitment, and will include first hand experiences from both the sponsor and site side of the fence. Attendees will walk away from this session with a clear understanding of the following key topics:
- How patient databases are constructed
- How patient privacy / HIPPA guidelines are accounted for
- Strengths and weakness of data-based recruitment vs. traditional recruitment strategies
- Key metrics derived from a data-based approach
- Key benefits to sites
- Key considerations / questions to ask when evaluating a data approach
- Beyond the data: Importance of site and patient support services (regardless of recruitment approach)
Facilitator:
Bruce Gould, MBA, Director, Business Development, Acurian, Inc.
Panelists:
Audrey Rossow, Clinical Research Consultant
Al Peters, Site Manager, Beacon Clinical Research
12:15 Luncheon
RECRUITMENT OF SPECIAL POPULATIONS
1:30 Recruiting Participants with Advanced Life-Limiting Illness
Amy Abernethy, M.D., Assistant Professor, Medicine/Oncology, Duke University Medical Center
This presentation will address the challenges to recruitment and retention that are introduced when clinical trials seek to enroll patients who are terminally ill or facing advanced life limiting illness. This is a fragile and vulnerable population, who are commonly cognitively or severely functionally impaired, and often have substantial family and/or caregiver input. The speaker will present results of: 1) a systematic review of strategies used to accrue terminally-ill clinical trials participants, and of barriers to accrual in these populations; and 2) a multi-faceted recruitment/retention strategy informed by the results of this systematic review that successfully enrolled 461 participants from a single site in 26 months. Both practical and philosophical barriers to enrollment will be described, together with pragmatic strategies for overcoming these barriers. Strategies introduced will include: a triage algorithm, dedicated recruitment nurse, reduction of participant burden, simplified consent documents, role-play training for recruitment and enrollment visits, standardized wording for key patient-centered messages, proxy consenting, focused outreach and education, methods for addressing gate-keeping, continuous study performance monitoring, and quality assurance.
2:00 Addressing the Challenges of Recruiting for Alzheimer’s Disease Studies
Paula Moore, Director, Clinical Trials, Medical Science, Alzheimer’s Association
Through our close contacts with colleagues in the government, the academic community and the pharmaceutical industry, the Alzheimer’s Association has concluded that the challenge of recruiting and retaining study participants will soon become a major impediment in developing the next-generation of Alzheimer’s drugs. Seeking to recruit from an inadequate pool of volunteers, investigators conducting AD trials face a number of unique challenges. Decisions about research participation are typically made “by committee” with caregivers, family members and primary care physicians all providing input. Alzheimer’s is a disease of the elderly whose concomitant health problems and related medication regimens frequently preclude study participation. In addition, most protocols require patients to be living in the community with full-time caregivers willing to observe and chart activities of daily living and capable of transporting study participants to and from site visits. Furthermore, market research reveals almost no awareness of clinical study opportunities among patients, caregivers and physicians.
This session will describe the Alzheimer’s Association’s unique Clinical Studies Initiative and its efforts to address these critical issues in a recently completed nine-month pilot program. Attendees will:
- Hear the results of comprehensive market research into why primary care physicians fail to refer patients to AD studies
- Explore a unique grassroots campaign aimed at reaching minority and ethnic populations
- Learn key findings from the pilot program including practical suggestions on how to improve recruitment despite insufficient promotional budgets, public distrust and discouraging statistics about overall public awareness
2:30 It’s a Family Affair: Maximize Patient Recruitment for Pediatric Trials
Tammy Ice, Associate Director, Patient Recruitment, INC Research
This session will present key factors to consider when developing a recruitment and retention plan for pediatric trials. Understanding the protocol and patient populations can help determine the most effective strategies. INC Research will present its planning process and how it translated to successful ideas for pediatric recruitment and retention.
3:00 Networking Refreshment Break and Exhibit Viewing
ENHANCING PATIENT COMPLIANCE AND RETENTION
3:30 Ensuring Patient Retention in Long-Term Studies and Registries
Abbe Steel, Executive Director, Trial Enhancement Solutions, United BioSource Corporation
Next to recruitment, retention of enrolled patients is the greatest challenge to ensure the timely completion of clinical trials. Furthermore, when the study is to continue for a number of years the dropout rate can be considerable, causing timeline delays and increasing trial budgets. Patients that consent to participate in a long-term study do not always realize the commitment they have made, and when they see little to no value, their motivation to remain in the study dramatically decreases. This session will offer practical tools to enhance patient retention in long-terms studies and provide specific examples of activities pharmaceutical companies and CROs can implement to ensure successful study completion that is on schedule and on budget.
4:00 The Impact of Third-Party Payment Policy on Clinical Trials Enrollment and Retention
Amy Abernethy, M.D., Assistant Professor, Medicine/Oncology, Duke University Medical Center
This presentation will include the results of a newly-completed study commissioned by the Center for Medicare and Medicaid Services of The Evidence-based Practice Center, Center for Clinical Health Policy Research, Duke University Medical Center, on the impact of third-party payment policies on enrollment and retention in clinical trials, and the resulting evidence base. Topics include the results of an extensive literature review, the proceedings of the public forum held on this topic, and the results of interviews with 40 key informants including policy makers, clinical research investigators, clinical trial coordinators, and patient advocates.
4:30 Adjourn