Title: Partnerships to Advance Patient Recruitment and Retention in Clinical Research
Date(s) And Time(s): Oct 14 2010 8:00AM - Oct 15 2010 4:30PM
Location: Hilton Rockville Hotel
1750 Rockville Pike
Rockville, MD 20852
Interest Area(s): Clinical Research,Outsourcing,Project Management,Regulatory Affairs,Research & Development,Public Policy/Law/Corp. Compliance
Overview:
DIA and FDA Office of Women’s Health (OWH) Host First Patient Recruitment and Retention Conference.
DIA and FDA Office of Women’s Health OWH) are pleased to announce the first FDA-cosponsored patient recruitment and retention conference to broaden the understanding and solution-driven discussion for: • FDA, industry and academia collaborate and dialogue on challenges and solutions for adequate patient demographics in clinical research through enhanced recruitment and retention strategies • Reach consensus on issues, potential solutions and accountable resources • Increase awareness and educate stakeholders on the critical need to include diversity and sub group populations in clinical trials • Summarize major obstacles that can be overcome, solutions that can be adopted and demonstrate tools of success • Identify who is doing what in the area of recruitment and retention and explore partnerships and collaborations between organizations • Discuss future plans to revisit recruitment and retention issues in clinical research • Generate a white paper
KEYNOTE PRESENTERS Joshua M. Sharfstein, MD Vivian W. Pinn, MD (Click "Highlights" for more information on the Keynote Presenters)
CONFERENCE OVERVIEW Recruiting adequate numbers of clinical trial participants has always been difficult across diverse populations particularly in women, children, ethnic minorities and the aging sub-group populations. It is well-known and scientifically documented that different medicines affect these populations differently. Therefore, more inclusive protocols, plans and strategies are imperative in order to address known barriers and uncover others in order to facilitate and expedite enrollment of underrepresented populations.
This conference will allow key stakeholders including pharmaceutical companies, CROs, principal investigators, physicians, government, research institutions, and IRBs to engage in shared discussions and establish action plans eliminating disparities and advancing representation of sub-populations in clinical drug trials. The conference will focus on multi-factorial issues including: 1. Recruitment and retention barriers and motivations for different subgroup populations in clinical trials; 2. Regulatory and public health impact of under-representation of women, elderly and minority groups in clinical trials; 3. Current industry, CROs, principal investigators and research institutions practices to ensure adequate recruitment and retention of patients in clinical trials; 4. Innovative and successful solutions/strategies for recruiting and retaining diverse populations in clinical trials.
Learning Objectives:
Upon completion of this conference participants will be able to: 1. Describe the dilemmas of FDA, industry, academia, physicians and patients related to recruitment and retention of all subgroup populations in clinical drug trials 2. Discuss the impact of under-representation of certain patient populations in clinical drug trials on regulatory decision making and public health 3. Recognize that various demographic subpopulations of women may need different strategies for successful recruitment and retention 4. Apply the solutions/strategies that have been shown to be successful for recruitment and retention of all subgroup populations in clinical trials.
Target Audience: The conference audience will consist of regulators, academia, medical centers, research scientists, patient advocacy groups, reimbursement agencies, principal investigators, clinical research managers and decision makers who have influence in patient recruitment planning and implementation. The program will cover some of the trends and new approaches conceptually and how they are unfolding and their implications for managers and decision makers.
Event Code: 10018
Contact Information:
Constance Burnett, Program Developer Phone 215.293.5800 Fax 215.442.6199 email Constance.Burnett@diahome.org
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IACET: The Drug Information Association has been approved as an Authorized Provider by the International Association for Continuing Education and Training (IACET), 8405 Greensboro Drive, Suite 800, McLean, VA 22102; (703) 506-3275.
The Drug Information Association is authorized by IACET to offer 1.3 CEUs for this program.
| Partnerships to Advance Patient Recruitment and Re | IACET
| 1.30
| 0.100
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Disclosure Policy: It is Drug Information Association policy that all faculty participating in continuing education activities must disclose to the program audience (1) any real or apparent conflict(s) of interest related to the content of their presentation and (2) discussions of unlabeled or unapproved uses of drugs or medical devices. Faculty disclosures will be included in the course materials.
Statement of Credit: If you would like to receive a statement of credit, you must attend the program, scan your name badge at the DIA registration desk each day of the program, and complete the on-line credit request process through
My Transcript at www.diahome.org. Participants will be able to download a statement of credit upon successful submission of the credit request.
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The most convenient airport is Ronald Reagan National Airport and attendees should make airline reservations as early as possible to ensure availability. The Hilton Rockville Hotel is holding a block of rooms at the reduced rate below until September 22, 2010 for the DIA event attendees. Room availability at this rate is guaranteed only until this date or until the block is filled.
Single $189 Double $189
Attendees must make their own hotel reservations. Contact the Hilton Rockville Hotel by telephone at +1.301.468.1100 and mention the DIA event. The hotel is located at 1750 Rockville Pike, Rockville, MD 20852, USA.
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Meeting
| Charitable Nonprofit/Acad | $650.00 | | Industry | $1295.00 | | Government (Full Time) | $390.00 |
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KEYNOTE PRESENTERS
Dr. Joshua M. Sharfstein was appointed by President Obama to be the FDA Principal Deputy Commissioner, Food and Drugs, in March, 2009.
From December 2005 through March 2009, Dr. Sharfstein was the Commissioner of Health for the City of Baltimore, Maryland. In this position, he led efforts to expand literacy eff orts in pediatric primary care, facilitate the transition to Medicare Part D for disabled adults, engage college students in public health activities, increase influenza vaccination of healthcare workers, and expand access to effective treatment for opioid addiction. Under his leadership, the Baltimore Health Department and its affiliated agencies have won multiple national awards for innovative programs, and in 2008, Dr. Sharfstein was named Public Official of the Year by Governing Magazine.
From July 2001 to December 2005, Dr. Sharfstein served as minority professional staff of the Government Reform Committee of the U.S. House of Representatives for Congressman Henry A. Waxman. Dr. Sharfstein is a 1991 graduate of Harvard College, a 1996 graduate of Harvard Medical School, a 1999 graduate of the combined residency program in pediatrics at Boston Children’s Hospital and Boston Medical Center, and a 2001 graduate of the fellowship in general pediatrics at the Boston University School of Medicine.
Dr. Vivian Pinn is Associate Director for Research on Women’s Health; Director, Office of Research on Women’s Health, Office of the Director, National Institutes of Health, DHHS.
Dr. Pinn came to NIH from Howard University College of Medicine in Washington, DC, where she had been Professor and Chair of the Department of Pathology since 1982. Previously, she held appointments at Tufts University and Harvard Medical School. Dr. Pinn has been active in efforts to improve the health status and career opportunities for women and minorities, and currently co-chairs the NIH Working Group on Women in Biomedical Careers along with the Director of NIH. Her current major initiative is spearheading a national strategic planning effort to determine research and career development priorities for the NIH women’s health agenda for the next decade.
Dr. Pinn has received numerous honors, awards, and recognitions, and has been granted 11 honorary degrees of laws and science since 1992. She is a fellow of the American Academy of Arts and Sciences, was elected to the Institute of Medicine in 1995, and is an elected member of AOA and Sigma Xi. She also served as the 88th President of the National Medical Association (and second woman president) in 1989, in addition to leadership and membership in many other professional organizations and societies.
Dr. Pinn earned her B.A. from Wellesley College in Massachusetts and received her MD from the University of Virginia School of Medicine in 1967, where she was the only woman and minority in her class. She received her post-graduate training in pathology at the Massachusetts General Hospital, Harvard Medical School, before assuming faculty positions at the medical schools of Tufts and Howard Universities.
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