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Building and Filling Patient-Centered Trials

By Clinical Informatics News Staff 
September 4, 2013 | As drug discovery moves toward more personalized treatments, patient recruitment and patient-centered trial design is paramount. Well-enrolled, successful, cost-effective trials turn on the patients. An upcoming two-part event will delve into solutions for these issues. 
Clinical Trial Optimization: Strategy, Planning and Recruitment will be held October 21-23 in Bethesda, Maryland*. The first part of the event will focus on patient centricity for developing strategies for trial execution. Understanding patient segmentation helps shape and inform patient recruitment and retention strategies. Developing patient-centered trials allowing companies to better leverage online communities, telemedicine, mobile technologies, EMRs and virtual trials to increase clinical trial efficiency. 
The second part of the event will consider data-driven recruitment and retention. The average cost of clinical trials has risen to nearly 60% of total drug development costs. Patient recruitment delays and a low retention rate are key factors in this increase of costs, leading to delays in product launch and a subsequent reduction in product exclusivity. Patient recruitment, if not adequately planned and managed, can extend the development timeline by a number of years.
The event is sure to be packed with insights for building patient-centered trials and recruiting patients, but here are some of the sessions we’re most looking forward to.
The Editors 
The Tufts Center for the Study of Drug Development (CSDD) initiated a working group of 12 biopharmaceutical companies and CROs to gather critical patient recruitment and retention benchmark metrics across 151 studies and five therapeutic areas between 2008 and 2010. Mary Jo Lamberti, Senior Project Manager, Tufts CSDD, will report on the findings including analyses of enrollment achievement rates revealed differences by region and by therapeutic area and the relationship between recruit tactics and enrollment. Wednesday, October 23, 8:30 
As genomics reveals more about the differences among populations and adds to our knowledge about disease prevalence in certain groups, targeted recruitment will become more important to developing and delivering drugs to the groups most at risk. A session featuring speakers Bristol-Myers Squibb, MD Anderson Cancer Center, and the Navita Clinical Strategy Group will address recruitment and retention of minority patients including the challenges to recruiting minorities and women, and how socioeconomic status, residential segregation, and immigration patterns impact study enrollment. Wednesday, October 23, 11-12:30 
“Patient Centricity” is a “motherhood and apple pie” concept, but means different things to different people, says Jane Perlmutter, President and Founder of the Gemini Group and Steering Committee Member of the Clinical Trials Transformation Initiative. She’ll look at what patients and patient advocates mean by “patient centricity,” and how this may differ from what clinical trialists mean. The session will also consider implications for planning and implementing clinical trials that will rapidly accrue patients. Monday, October 21, 11:45 
Several interesting case studies and tools will be presented by pharma users. 
Sameer Tandon, Group Head of outsourcing and sourcing at Novartis will discuss the proper use of the Feasibility Questionnaire, and present some tactics/tips on the components of feasibility and some tools and metrics to consider. Monday, October 21, 2:00 
Chris Conklin, associate director of Clinical Research and Global Trial Optimization at Merck will present a pilot project using a social media platform for sponsors and investigator site personnel. Wednesday, October 23, 1:45 
Amy Loescher, Director, Clinical Trials Innovation, Janssen R&D, will discuss Janssen’s successful deployment of a commercially-available enrollment forecasting software. The pilot project that she’ll discuss—complete with hypothesis, objectives, test plan, result, analysis, conclusion—created a clear business case for next steps and blueprint for scale-up. Wednesday, October 23, 9:30 
Social media is proving itself to contain a host of opportunities and challenges for clinical trials with respect to program planning, patient recruitment and pharmacovigilance. Stella Stergiopoulos, project manager at the Tufts Center for the Study of Drug Development, will present primary and secondary data gathered by Tufts CSDD and a working group of pharmaceutical executives, proposing principles and standard practices involving social media. Tuesday, October 22, 11:15 
*Clinical Trial Optimization: Strategy, Planning and Recruitment; Cambridge Healthtech Institute; October 21-23, Bethesda, Maryland. Cambridge Healthtech Institute is the parent organization for Clinical Informatics News. 
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