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Patient Recruitment and Retention [clear filter]
Monday, June 27
 

8:30am EDT

#103: Decision Tools to Drive Efficient Recruitment and Retention: Making Recruitment a Science
Limited Capacity seats available

Component Type: Session
Level: Intermediate
CE: CME 1.25; IACET 1.25; RN 1.25

In this session, we will display a tool that helps integrate recruitment planning into the fabric of a trial’s operational design. We will also debate the most appropriate usage of the tool and how to integrate it into the planning process.

Learning Objectives

Describe a new tools developed by sponsors to determine the best recruitment strategy for any given protocol; Show the impact these tools have had on developing budgets and tactics for recruitment planning; Discuss the positives and potential pitfalls of using these tools.

Chair

James Kremidas

Speaker

Matchmaking: Systematizing Best Fit Tactics for Study Needs
Lewis Millen

The Art and Science of Site Level Recruitment Planning: Tools, Tactics, and Tips?
Beth D. Harper, MBA



Chair
avatar for James Kremidas

James Kremidas

Executive Director, Association of Clinical Research Professionals (ACRP)
Jim Kremidas is Executive Director for ACRP, a not-for-profit association that represents the clinical research enterprise. He was Senior Vice President, Patient Recruitment, at two different large CROs for over six years where he and his team were responsible for developing and implementing... Read More →

Speakers
avatar for Beth Harper

Beth Harper

President, Clinical Performance Partners, Inc.
Beth is the President of Clinical Performance Partners, Inc. a clinical research consulting firm specializing in enrollment and site performance management. She has passionately pursued solutions for optimizing protocols, enhancing patient recruitment and retention and improving sponsor... Read More →
avatar for Lewis Millen

Lewis Millen

Operational Intelligence Leader, Roche Products Limited


Monday June 27, 2016 8:30am - 9:45am EDT
113B Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA

10:45am EDT

#125: Patient Recruitment in Rare Diseases: Ideas and Framework for Out-of-the-Box Exploration
Limited Capacity seats available

Component Type: Session
Level: Basic
CE: ACPE 1.25 Knowledge UAN: 0286-0000-16-520-L01-P; CME 1.25; IACET 1.25; RN 1.25

Patient recruitment is a challenging activity, which becomes even more so in rare diseases where populations are small, patients are geographically dispersed, and eligible subjects may not be physically (or economically) capable of traveling to a trial site. Unfortunately, current recruiting methods (e.g., listing on trial and patient organization websites, relying on key opinion leaders and trial investigators, billboards) may be limited in reach, overly reliant on busy physicians, and too costly or cost-ineffective. It behooves clinical trialists in rare diseases to consider mechanisms beyond these standard approaches. The aim of this session is to catalyze unconventional thinking and to provide a framework to organize innovative recruitment ideas.

Learning Objectives

Discuss the challenges of patient recruitment in rare diseases; Compare conventional and out-of-the-box ideas for patient recruitment; Illustrate a framework for organizing innovative recruitment ideas.

Chair

Badri Rengarajan, MD

Speaker

Leveraging Claims Data for Targeted Recruitment
Donny Chen, MBA

Direct-to-Patient Digital Recruitment: A Targeted Approach to Recruitment Enrollment and Retention Problems
Bethany Bray

Bringing Clinical Trials to Patients: Leveraging Convergent Data Sources to Accelerate Recruitment
Scott Douglas Schliebner, MPH



Chair
avatar for Badri Rengarajan

Badri Rengarajan

Medical Affairs Lead, ASPIRE Unit, Actelion
15 years’ experience across medical affairs, product development strategy and new product planning, regulatory affairs, business development, strategy: Former Board President, International Pemphigus and Pemphigoid Foundation (rare disease foundation); Senior Medical Director, Archimedes... Read More →

Speakers
avatar for Bethany Bray

Bethany Bray

Chief Executive Officer, Co-Founder, AutoCruitment
Bethany Bray, Oncology and Neuroscience Researcher, Entrepreneur and Technologist, founded AutoCruitment (a technology-enabled digital patient recruitment platform) with a vision to utilize the power of the internet to address recruitment, enrollment and retention problems in clinical... Read More →
avatar for Donny Chen

Donny Chen

Senior Director, Medical Affairs Research Operations, PPD
Donny Chen, senior director of medical affairs research operations at PPD, has spent the last 18 years designing and spearheading observational research studies in a variety of therapeutic areas, with particular expertise in strategy, analysis and project management. Mr. Chen graduated... Read More →
avatar for Scott Schliebner

Scott Schliebner

Senior Vice President, Center for Rare Diseases, PRA Health Sciences
Scott Schliebner is a clinical strategist with a 20+ year background in clinical development specializing in rare diseases and orphan drug development. His experience encompasses all trial phases; a broad variety of study designs; interventional and observational studies; across a... Read More →


Monday June 27, 2016 10:45am - 12:00pm EDT
113A Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA
  Trk 01: Clinical Operations, Session
 
Wednesday, June 29
 

10:30am EDT

#308: Patient Recruitment Workshop: Survey Results and Practical Application
Component Type: Workshop
Level: Intermediate
CE: ACPE 1.25 Application UAN: 0286-0000-16-519-L01-P; CME 1.25; IACET 1.25; RN 1.25

This interactive workshop will incorporate the patient engagement survey results from the Tufts Center for the Study of Drug Development, a large group discussion, and small group breakouts to develop practical solutions for pediatric, rare disease, oncology, and other clinical studies.

**Due to workshop format, seating is limited and will be available on a first come, first served basis.

The Pennsylvania Convention Center has stringent regulations on maximum room capacities, and they are strictly enforced. Once all seats are occupied, DIA will be required to close the workshop, and no more participants will be admitted. Interested attendees are encouraged to arrive early in order to ensure seating.

Learning Objectives

Discuss the findings of the latest Tufts CSDD patient engagement surveys; Identify obstacles and opportunities to improve patient engagement in clinical trials; Propose at least three solutions which address patient engagement needs.

Chair

Robin F Marcus

Speaker

Facilitator
Stella Stergiopoulos



Chair
avatar for Robin Marcus

Robin Marcus

SVP Business Development & Strategic Initiatives, GlobalCare Clinical Trials
Robin is Sr. Vice President with GlobalCare Clinical Trials. In the past 25 years she has become known as an innovative healthcare executive focused on launching new products and services. Her talents have been leveraged with companies of all sizes including Caremark, Mediware & Home... Read More →

Speakers
avatar for Stella Stergiopoulos

Stella Stergiopoulos

Research Fellow, Tufts Center for the Study of Drug Development
Ms. Stella Stergiopoulos leads multi-sponsored research projects at Tufts CSDD. She has experience conducting research on pharmaceutical industry practices and trends affecting pharmacovigilance, non-clinical drug development, pharmaceutical outsourcing practices, cycle time metrics... Read More →


Wednesday June 29, 2016 10:30am - 11:45am EDT
102AB Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA
  Trk 01: Clinical Operations, Workshop

2:00pm EDT

#335: Multi-Ethnic, Special Populations, and Patient Diversity in Clinical Trials
Limited Capacity seats available

Component Type: Symposium
Level: Intermediate
CE: ACPE 1.25 Knowledge UAN: 0286-0000-16-521-L04-P; CME 1.25; IACET 1.25; RN 1.25

This symposium will cover multi-ethnic, special populations, and patient diversity in clinical trials. It will illustrate an assessment of over 10,000 trials, recently conducted by sponsor companies, to quantify the differences of pediatric trials from adult studies. It will illuminate the learning’s in site identification, site qualification, and enrollment from the DOVE study, a 14-country study representing a mix of traditional and developing regions. It will then evaluate and analyze the available data regarding the characteristics of medicines approved for older patients in European Union and the US, contributing to the information in the geriatric population in order to discuss their access to innovative drugs.

Learning Objectives

Discuss country-specific differentiation in site activation, subject recruitment, and data quality, especially around developing regions, as demonstrated by the DOVE study; Classify the difference in performance between pediatric and adult studies; Describe the challenge of addressing geriatrics adequately in the assessment of medicines including the necessity to increase global regulatory dialogue and communication.

Chair

Lisa Palladino Kim, MS

Speaker

Pediatric Studies: Experiences, Best Practices, and Trends
Conrad Hawkins

Conduct of Clinical Trials in Special Populations and Developing Regions: Challenges and Opportunities
Stephen G. Reams, MA

Medicines Development for Geriatric Patients: Unmet Needs?
Dinah Duarte, PharmD, MSc



Chair
avatar for Lisa Kim

Lisa Kim

Director of Capstone / Lecturer, Rutgers School of Health Professions, United States
Lisa Palladino Kim, is the Director of Capstone (Field Mentorship) and a Lecturer at Rutgers School of Health Professions MS in Clinical Trial Sciences Program. Lisa has 15 yrs of pharma expertise, concentrated in Clinical Ops (Pt Recruitment, Data Mgt, and Project Mgt), which allowed... Read More →

Speakers
avatar for Dinah Duarte

Dinah Duarte

Scientific Evaluation Unit, Directorate of Medicinal Products, INFARMED
Dr. Dinah Duarte is a senior assessor at the Scientific Evaluation Unit at the Directorate of Medicinal Products, in the Portuguese regulatory authority for medicines and health products (INFARMED). She is an expert member at the European Medicines Agency (EMA); the current Committee... Read More →
avatar for Conrad Hawkins

Conrad Hawkins

Associate Consultant, KMR Group Inc.
Conrad Hawkins is an associate consultant of KMR Group, a firm specializing in measuring and improving biopharmaceutical R&D performance, evaluating clinical productivity, clinical trial cycle times and enrollment processes as well as study start-up. His areas of expertise include... Read More →
avatar for Stephen Reams

Stephen Reams

Advisor, Clinical Project Management, Eli Lilly and Company
Steve has more than 27 years experience in the pharmaceutical industry, including assignments in both discovery research and clinical product development at Eli Lilly and Company. His roles have spanned multiple disciplines including clinical operations, data management, and clinical... Read More →


Wednesday June 29, 2016 2:00pm - 3:15pm EDT
113C Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA