CDRN/PPRN Awardee Welcome Webinar

CDRN/PPRN Awardee Welcome Webinar

Webinar Agenda 1. Welcome from PCORI s PCORnet Program Director Rachael Fleurence Description of PCORI team and next steps 2. Welcome from the PCORnet Coordinating Center Co-directors Rich Platt & Rob Califf, Description of PCORnet Coordinating Center roles and resources 3. Overview of welcome packet by PCORnet PMO Director Kim Lane 2

Welcome to PCORnet! 3

PCORnet: the National Patient-Centered Clinical Research Network The goal of PCORI s National Patient-Centered Clinical Research Network Program is to improve the nation s capacity to conduct CER efficiently, by creating a large, highly representative, national patient-centered clinical research network for conducting clinical outcomes research. The vision is to support a learning US healthcare system, which will allow for large-scale research to be conducted with enhanced accuracy and efficiency. PCORnet will function through a single, interoperable data research network, the PCORnet DRN.

Overall objectives of PCORnet: achieving a single functional research network Engagement of patients, providers and health system leaders Support of multi-center observational and interventional CER studies Openness to external data and research partners participating with PCORI-funded networks Availability to researchers not directly affiliated with PCORnet partners through collaborative arrangements. PCORnet partners will be encouraged to use the resources created with PCORI s support for a range of activities supported by other organizations. 5

PCORnet Program Team at PCORI Joe Selby, MD, MPH Executive Director Rachael Fleurence, PhD Program Director CDRN CDRN PPRN PPRN Sarah Greene, MPH Senior Program Officer Maryan Zirkle, MD, MS Program Officer Sarah Daugherty, PhD, MPH Senior Program Officer Sarita Wahba, MPH Senior Program Associate 6

PCORnet Program Team at PCORI Martin Brown, PhD Sr. Scientific Advisor Tara Sanker Senior Administrative Assistant Natalie Wegener Program Coordinator Rachel Rath, MPH Program Coordinator 7

What to expect from your PCORI Program Officer Contract, milestone and budget negotiations as well as finalization of your proposal (December-January) Brief phone Meet&Greet in early January to answer questions concerning milestones and revisions PCORI Contracts team will address the contract itself The PCORI Program Officer will be engaged with you throughout the 18 months to support your progress Thank you to the CDRNs for responding to PCORI s questions in November!

Information On Contracting and Milestones You will receive the contract with a set of milestones, as well as the PCORI program team s feedback These are common, generic, milestones that reflect goals expected from all awardees based on the Program Funding Announcements The final version of your proposal should describe how your CDRN or PPRN will meet these milestones Your Program Officer will work with you on finalizing these by January 15 th 2014 PCORnet s success as single research network depends on the common goals being met

Coordinating Center Co-Directors Richard Platt, MD, MSc Robert M. Califf, MD

Organizations and Roles Harvard Pilgrim Health Care Institute: Overall lead Duke Clinical Research Institute: AcademyHealth: Brookings Institution: Group Health Research Institute: Technical assistance Self-evaluation activities Convening Health systems interactions Center for Medical Technology Policy: Patient and consumer engagement Center for Democracy & Technology: Privacy Johns Hopkins Berman Inst of Bioethics: Ethics / regulatory America s Health Insurance Plans: RAND Corporation: Health plan engagement External evaluator 12

CC Executive Leadership Committee Richard Platt, MD, MSc, Professor and Chair, Harvard Medical School Dept of Population Medicine, Harvard Pilgrim Health Care Institute Robert Califf, MD, Director, Duke Translational Medicine Institute, Vice Chancellor for Clinical and Translational Research Eric Larson, MD, MPH, MACP, VP for Research, Group Health; Executive Director & Senior Investigator, Group Health Research Institute Mark McClellan, MD, PhD, Senior Fellow, Brookings Institution Erin Holve, PhD, Senior Director, AcademyHealth Bray Patrick-Lake, Director of Stakeholder Management, Duke Translational Medicine Institute

CC Project Management Office (PMO) Director: Kim Lane (HPHCI) Program Management & Task Force Liaison: Beth Syat (HPHCI) Technical Assistance: Cheri Janning (DCRI) Convening: Greg Daniel (Brookings) Internal Program Evaluation: Erin Holve (AcademyHealth)

Task Forces

Governance & Collaboration Task Force Leads: Rich Platt, Erin Holve Program Manager: Raj Sabharwal Goal/Purpose: Assist with establishing policies that support trust and collaboration

Data Standards, Security & Network Infrastructure Task Force Leads: Jeff Brown (HPHCI), Lesley Curtis (DCRI) Project Manager: Shelley Rusincovitch (DCRI) Goal/Purpose: Create the PCORnet Distributed Research Network that facilitates multi-site research across the CDRNs, PPRNs, and others.

Data Privacy Task Force Lead: Deven McGraw (Center for Democracy & Technology [CDT]) Program Manager: Alice Leiter (CDT) Goal/Purpose: Develop privacy policies to govern data sharing. Identify privacy issues raising particular challenges and highlight promising or best practices for addressing them.

Patient & Consumer Engagement in Research Task Force Lead: Sean Tunis (Center for Medical Technology Policy [CMTP]) Project Manager: Ellen Tambor (CMTP) Goal/Purpose: Ensure engagement of patients and consumers in all components of PCORnet. Serve as technical resource, with PCORI staff.

Health Systems Interactions Task Force Leads: Eric Larson, Katherine Newton Project Manager: Ella Thompson Goal/Purpose: Help the CDRN research groups create a supportive environment for clinical research with the clinicians and leadership of participating health care systems.

Ethics and Regulatory Task Force Leads: Rob Califf, Jeremy Sugarman (Hopkins), Joseph Ali (Hopkins) Project Manager: Tammy Reece (DCRI) Goal/Purpose: Address the ethical and regulatory issues related to research that arise in PCORnet s work.

Patient-Reported Outcomes Task Force Lead: Amy Abernethy (DCRI) Project Manager: Tracie Locklear (DCRI) Goal/Purpose: Focus on measurement, collection, and analysis of patient-generated information.

Clinical Trials Task Force Lead: Rob Califf Project Manager: Lisa Berdan Goal/Purpose: 1. Adopt methods, standards and quality by design principles for clinical trials using PCORnet. 2. Develop pathways for PCORnet interventional clinical trials, oversee trial conduct, feed back learnings to the generalized knowledge base.

Generate Topics for an Interventional Trial within PCORnet PCORI will release a limited competition funding announcement for CDRNs in Summer 2014 to support an interventional trial. As a first step to developing this announcement, we are inviting PPRN and CDRN awardees to participate in 1) Generating suitable topics for this first clinical trial and 2) Prioritizing potential topics Step 1 Step 2 Step 3 Step 4 Topic Generation CDRNs/PPRNs Rank Topics Using PCORI's Research Prioritization Criteria PCORI Program Development Committee (PDC) & PCORI Board of Governors Approve Final Topic for the Clinical Trial PCORI issues Funding Announcement May 2014 24

Obesity Task Force Lead: Matthew Gillman (HPHCI) Project Manager: Chelsea Jenter (HPHCI) Goal/Purpose: Facilitate construction of the obesity cohort at each CDRN, and identify potential research uses

Rare Diseases Task Force Leads: Priya Kishnani (DCRI) & Rachel Richesson (DCRI) Project Manager: Becky Wilgus (DCRI) Goal/Purpose: Support identification of populations and research priorities for studies of rare diseases Act as source of information for rare diseases research Act as discussion and advocacy forum to identify and advocate for needs specific to rare diseases research

Biorepositories Task Force Lead: Kristin Newby (DCRI) Project Manager: Diane Uzarski (DCRI) Goal/Purpose: Support a regulatory-compliant, comprehensive, and sustainable Network-wide biorepository to serve PCORnet research

Resources

Web Tools PCORnet.org the public website for the Coordinating Center and Partners: http://pcornet.org Private webspace for file sharing and project management tools invitations will be sent to each Partner

Resource Center The PCORnet Resource Center assists the public and awardees it can be accessed via all pages of http://pcornet.org Submit inquiries through these channels: Office Hours will be posted on the website PCORnet Support Request Web Form PCORnet Resource Center Support Line Toll Free: (844) 275-6276 / 844-ASK-NCRN Local: (919) 668-2286 (Verizon Wireless) Hours: Monday-Friday 8AM-8PM Eastern Standard Time

Welcome Packet Overview Task Due date Complete Partner Key Personnel Survey 12/23/2013 Schedule PCORnet CC Welcome call 1/3/2014 Complete Technical Survey 1/8/2014 Complete PPRN Patient Engagement Survey 1/8/2014 Complete Clinical Trial Topic Generation Survey 1/8/2014 January 21-22 PCORnet Kickoff Meeting registration 1/8/2014 Submit Steering Committee member nomination and Task Force member and co-chair nominations 1/8/2014 Schedule onboarding call 1/17/2014

Technical Survey The survey addresses the technical infrastructure of each CDRN/PPRN network 32

Additional Surveys Clinical Trial Topic Generation Survey Submit topics for future RFA Patient Engagement Survey To assess PPRN s perceived needs and collaborative interests. Nomination Form Steering Committee member and Task Force member and co-chair nominations Partner Key Personnel Key for communication next steps 33

January 21-22 PCORnet Kickoff Meeting PCORnet: Building Evidence through Innovation and Collaboration Launch the development of the nation s most ambitious and promising clinical research network Attendance for up to two representatives per PCORnet Partner Registration and travel information found in welcome packet 34

Communication Communication throughout the PCORI National Clinical Research Network will be streamlined through the PCORnet Coordinating Center Resource Center. You may hear from us via the following email addresses: info@pcornet.org pmo@pcornet.org meetings@pcornet.org resourcecenter@pcornet.org 35

Thank you Questions? 36