METHODS AND PROCESSES DOMAIN TASK FORCE. February 4, 2015

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1 METHODS AND PROCESSES DOMAIN TASK FORCE February 4, 2015

2 Overview DTF Lead Team Goals Examples of potential projects Seeking broader input Next steps

3 DTF Lead Team William Trochim, Weill Cornell Medical College (co-chair) Sundeep Khosla, Mayo Clinic (Steering committee appointee co-chair) Brad Pollock, University of California, Davis Harry Selker, Tufts University Anantha Shekhar, Indiana University School of Medicine Todd Wilson, NCATS/DCI representative Jodell Jackson, C4 Project Manager

4 Goals Advance the scientific study of the process of conducting translational science itself and thereby enable significant advances in translation Contribute to novel methods across the spectrum of translational science From conceptual and analytical to logistical methods To accelerate research from bench to bedside to public benefit, and To improve quality, efficiency, and impact of research

5 Examples: Conceptual and Analytic Methods Novel trial designs that maximize statistical power and maximize applicability to broad impact on health New adaptive trial design approaches Developing clinical trial paradigms for personalized medicine Addressing heterogeneity of treatment effect Novel data collection e.g., Web apps, embedded in EHR Methods of effectiveness and pragmatic trials

6 Examples: Logistic Methods Develop a standard operating procedure for facilitating the conduct of high priority NIH-funded clinical trials through the CTSA network: Engagement of sites at the point of conception Issues related to identification of site PIs, contracting, IRB reciprocity, budgeting, cohort identification Identifying the key barriers and delays to translation (from early to late phases) and developing solutions Prior cross-ctsa project examples IRB I and IRB II Pilot Projects Contracts Pilot Project

7 Examples: Improving impact of research Late stage translation: Facilitate the development of approaches to enhance dissemination and implementation research to ultimately improve health by better access and compliance with therapies Define and measure the impact of a body of translational work

8 Seeking broader input from the DTF Task Force brainstorming of potential ideas Each TF member generated brief statements 127 ideas were brainstormed over a period of approximately 10 days Lead Team compiled and synthesized these The warning label : brainstorming is only one source of good ideas. These statements provide us with a picture of what people initially have on their minds Still need to keep in mind IOM report and Working Group report Input from the PIs

9 Examples of some of the 127 brainstormed ideas 30. Identify methods for improving study activation time/recruitment 43. Explore how data standards can be used to facilitate interoperability and exchange. 61. Support research in adaptive clinical trials -- adaptive in technology and treatment optimization as well as response adaptive. Test pragmatic and implementable solutions beyond just drugs. 70. Establish a work group to define "impact" of a significant body of translational research work. 86. Develop, demonstrate, and disseminate (the NCATS motto) new and more efficient clinical trial designs Facilitate the development of approaches to enhance dissemination and implementation research to ultimately improve health by better access and compliance with therapies

10 Initial Classification of Brainstormed Ideas

11 Obtain input from PIs after meeting NEXT STEPS Revise ideas to final set Prioritize ideas Discussion and development of initial Working Groups around specific projects with defined timelines and outcomes Nominate 3 community representatives

The CTSA Program: Collaborative Innovation for Translational Research

The CTSA Program: Collaborative Innovation for Translational Research Petra Kaufmann, MD, MSc Director, Division of Clinical Innovation NCATS ADVISORY COUNCIL MEETING JUNE 18, 2015 Transforming the CTSA