Tuesday, May 12, 2009
Sponsored by
7:45AM Breakfast Presentation
Overcoming the Six Risk Areas of Study Enrollment
Matt Kibby, Leader, Global Operations, BBK Worldwide
Whether conducted on a domestic, multinational, or global level, every clinical trial faces its own unique challenges from one or more of six enrollment risk areas. As a study sponsor, knowing how to assess and overcome your study’s risks is the key to designing a campaign that is not only effective, but also cost-efficient. It’s also the key to knowing which aspects of your campaign you need to outsource, and which you can manage in house.
8:45 Opening Remarks
Brian York, Director, Feasbility and Patient Recruitment, Amgen
9:00 Current Challenges in Phase I Pediatric Research
Barry Mangum, PharmD, FCP, Associate Professor Clinical Pharmacology, Duke University Medical Center, Duke Clinical Research Institute
The initiation of regulator demands from both the FDA and the EMEA have increased the needs for more better centers of excellence to aid in the recruitment of pediatric subjects. Ethical issues still remain for the clinical professional, parents, and the IRBs associate with pediatric clinical research. These challenges will be explored with some hint of possible solutions for recruitment, retention, and proper study designs. Also, lessons learned will be shared in this presentation.
At the completion of this presentation the attendees will be able to:
List three challenges of pediatric clinical research in Phase I
Define the regulatory framework of the EMEA and FDA for performing pediatric clinical research in early phases
Provide two solutions to recruitment
Give one example of a lesson learns in study design
9:30 Subject Recruitment Strategies from the Perspective of an Institutional Review Board
James Saunders, Vice President, New England Institutional Review Board
Recruiting and retaining study subjects is an increasingly difficult task for U.S.-based clinical trials. This talk intends to review recruitment and retention techniques from the IRB’s standpoint. In addition to the more conventional techniques, this talk will also review techniques newer, electronic techniques, including clinical trial websites controlled by the trial’s sponsor, the use of search engines to recruit subjects, etc. In this presentation, attendees will gain:
An understanding of the ethical principles and U.S. regulations underlying IRB review of subject recruitment and retention plans
An understanding of the way an IRB interprets these regulations in light of developments in the clinical trials industry not contemplated by the regulations
Sponsored by
10:00 Informed Consent, Informed Decision, and the Good Recruitment Practice Initiative
Linda Wolf, Director of Alliance Development and Recruitment Training, BBK Worldwide
Good Recruitment PracticeSM (GRP) is a set of principles for improving the recruitment of patients for clinical studies. An industry-wide initiative, GRP provides ideas and methodologies for increasing public awareness and trust in clinical research – including the essential tenet that, over and above signing an informed consent form, patients make and maintain an informed decision to participate in a clinical trial.
10:15 Networking Coffee Break with Exhibit Viewing
10:45 Patient Recruitment in Central and Eastern Europe – a CRO Perspective Sponsored by
Kerry Dyson, Head of UK Operations, CROM
Including investigational sites located in countries within Central and Eastern Europe is a strategy available to sponsors wishing to ensure recruitment of subjects to their studies is maximized. This presentation provides an insight into key factors associated with successful implementation of this strategy, and focuses on the importance of individual site selection. The quality and performance of centres located in Central and Eastern Europe in comparison to those in Western Europe and the USA will also be discussed.
11:00 Regulatory Challenges and Expectations in Latin America and Asia Pacific to Effective Clinical Trial Development
Jerry Stewart, JD, MS, RPh, Associate Director, Global Regulatory Affairs, Asia-Pacific & Latin America, Wyeth Pharmaceuticals
Today, more than ever, clinical research is experiencing a geographical shift in country selection, and clinical trials are truly becoming more and more “global.” One of industry’s goals is to execute simultaneous global development. That is, to use global data to develop a single dossier (e.g., Clinical Trial Application) that supports the next critical phase of development, enabling simultaneous submissions to and approvals from health authorities and ethics committees globally. There are a number of barriers that significantly restrict simultaneous development, ultimately delaying the availability of innovative drug therapy to emerging markets and limiting patient access to new and preventative treatment. Presentation topics:
Regulatory barriers in the AP and LA regions to simultaneous clinical development
Industry’s expectations of a health authority’s regulatory framework
Clinical elements to the ideal clinical trial infrastructure
11:30 Global Regulatory Strategies for the Optimization of Modern Study Designs: Challenges of Using Placebo and Active Reference Products
Alex Kudrin, M.D., Ph.D., former Senior Manager, Global Clinical Development, GlaxoSmithKline Biologicals (Belgium)
The presentation is intended to outline challenges of conducting placebo-controlled clinical trials in different countries (including South Asian region). The role of an adequate study preparation, training of investigators and strategies for in-depth characterisation of drop-outs (non-completers) are described. The presentation will give a regulatory outlook on challenges in planning, design and execution of studies. Audience will gain an understanding of regulatory and ethical principles of study conduct and the use of placebo.
Hosted by
12:00 PM Luncheon Presentation
Clinical Trial Patient and Site Recruitment Optimization: Reduce Risk and Accurately Forecast Results
Kurt Shampine, Senior Vice President , Life Science Solutions, ProModel Corporation
According to separate studies conducted by McKinsey Quarterly and IBM Global Industries, more than 80% of all clinical trials experience significant delays costing pharmaceutical companies upwards of $35,000 a day per trial. In many cases, these delays can be attributed to the difficulty in predicting patient recruitment. In working with our pharmaceutical Customers, we have developed a reliable, scalable and data-driven methodology & technology solution that accurately forecasts LSFV, LSLV or any trial milestones prior to and during recruitment. This presentation will explore how we are helping our customers to:
- Experiment with and optimize the number of sites any trial will require.
- Mitigate risk around recruitment by accurately projecting “True” patient enrollment and retention.
- Accurately project trial milestone dates such as LSFV, LSLV or close out.
- Accurately forecast the cost of the optimal trial solution.
- Enhancing Patient Retention and Adherence thru Technology and Training
1:30 Delivering Predictable Performance in Patient Recruitment (DRAFT)
Alex Lancksweert, Director, Performance Metrics & Benchmarking, Global Clinical Operations, GlaxoSmithKline R&D
More than 90% of clinical trial sites delay enrollment (CenterWatch) and Out-of-Pocket costs are $1.2M on average per study for each month delayed. Through the application of rich visual and predictive technologies, learn how to deliver more predictable performance.
2:00 The Importance of Standardizing Study Coordinator Training: Essential Elements
April Bower, R.N., M.S., Health Program Specialist, National Center of Complementary and Alternative Medicine, Office of Clinical and Regulatory Affairs, National Institutes of Health
This presentation will offer an overview of basic topics essential to study coordinator training, including academic and industry standards, IRB expectations, accepted documentation standards, recordkeeping, patient safety, and interaction with government agencies. As a regulatory professional and former study coordinator, I have witnessed firsthand the gaps in study coordinator training nationwide and the need for a standardized, low-to-no-cost training program that should be entry-into-practice for all study coordinators. This proposal presents an overview of those elements and why they are important. The audience will learn why on-the-job training is inadequate, the essential elements of comprehensive study coordinator training, and the concepts needed to apply to any coordinator position, either academic or industry-related.
2:30 Networking Refreshment Break
3:00 Increasing the Communication between the Sponsor and Investigational Sites to Facilitate Patient Recruitment and the Timely Collection of Quality Data
Matthew R. Dauphin, Associate Director, Global Clinical Programs, Clinical Research & Development, Shire Development Inc.
As the pressure to introduce new drugs in a cost effective manner increases, biopharmaceutical companies continue to strive for increased efficiency in clinical study execution. Outsourcing clinical study management and monitoring to contract research organizations is the primary method of facilitating timely study execution. Despite the expertise that contract research organizations demonstrate with clinical study management, direct investigational site interaction, and overall study execution, it remains critical for the clinical trial’s sponsor to communicate with investigators throughout all phases of a clinical study. Defining the level and method of sponsor/investigator interaction during study start-up, while maintaining such interaction throughout study conduct, may increase investigator understanding of a study’s importance to a clinical development program and consequently facilitate patient recruitment and the timely collection of quality data.
Define and execute an effective communication plan between sponsor, service provider(s), and investigators.
Effectively partner with CRO project management and/or clinical research associates in the oversight of investigational sites.
Effectively partner with a recruitment and retention service provider to manage a global recruitment and retention campaign spanning multiple cultures with a mixed awareness of an accepted diagnosis.
Effectively partner with investigational sites to increase investigator awareness of study importance, confidence with study conduct, and overall investigational staff morale.
3:30 Case Study: Recruitment and Retention Planning at the Site Level
Kim Hirsch, R.N., Certified Clinical Research Associate, United States Clinical Research Unit/Regional Monitoring Team, Sanofi-Aventis
Too often there is not enough partnering with sites by the sponsor to achieve enrollment and retention goals. Our goal is to work with our sites to identify their individual process for reaching their enrollment goals, define that process and document it, and then work with them to achieve those goals. We utilize individual R & R plans as tools to have that conversation, document the process, and to refer back to as the study progresses.
Attendees will learn how to discuss and implement a R & R plan at their sites
Attendees will learn how to use that R & R plan to continue the enrollment and retention dialogue through the life of the study (assess site progress with the initial plan, have difficult discussions with underperforming sites, revise and redo the initial plan depending on what progress has or has not been made)
Use information gleaned from R & R plans to examine trends for study as a whole (lead to potential amendments and adjustments).
4:00 The Recruitment Enhancement Core: Innovative Recruitment Strategies for Washington University School of Medicine
Charles Rathmann, Director, Recruitment Enhancement Core, Center for Applied Research Sciences, Washington University School of Medicine
The Recruitment Enhancement Core (REC) takes responsibility for enhancing recruitment university wide by passing a steady stream of qualified participants to the PI’s and study coordinators. The REC also provides assistance with creating targeted, comprehensive approaches to participant recruitment, which will maximize recruitment efforts for clinical trials (to include creative solutions to existing and potential recruitment challenges). Access to the Research Participant Registry, or RPR, database, in which potential participants can be queried by study inclusion and exclusion criterion, is a huge resource in this endeavor. Any advertising assistance, whether by print or electronic media, can be developed and placed strategically as well. The REC will also work with sponsors, both industry and government, to secure funding to enhance the advertising and recruitment efforts on all trials. The goal of the REC, is to free up the time of study coordinators and PI’s, so they can focus on consenting and enrolling participants, while the REC spends time trying to get interested, qualified patients to the studies that they desire to be included in. The proof of concept pilot for this new department and related strategies has yielded a 2 fold increase in enrollment accrual (60% to 125%), as of December, 2007.
4:30 Closing Remarks
4:45 End of Conference
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