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PCORI Board Approves $142.5 Million to Fund Expansion Phase of PCORnet, the National Patient-Centered Clinical Research Network

Awards to Support 34 Partner Networks, 7 of Them New to the Initiative

WASHINGTON, DC (July 21, 2015) – The Patient-Centered Outcomes Research Institute (PCORI) Board of Governors today approved nearly $142.5 million to support the ongoing development and expansion of an ambitious new resource for health research known as PCORnet, the National Patient-Centered Clinical Research Network.

The funds include support to add seven health data networks to this large, collaborative initiative, which is designed to link researchers, patient communities, clinicians, and health systems in productive research partnerships that leverage the power of large volumes of health data maintained by the partner networks.

PCORI is developing PCORnet to enhance the nation’s capacity to conduct patient-centered health outcomes research more quickly, less expensively, and with greater potential impact than is now possible. Through the active participation of patients and other healthcare stakeholders, PCORnet will ensure that research focuses on the questions and outcomes that matter most to patients and those who care for them.

The funding awards approved today will support a three-year second phase of development during which several research studies will begin. Specifically, the funding will support 34 individual health data networks that together make up PCORnet, including continued support for 27 networks selected to participate in PCORnet’s first phase of development, which began in April 2014. These will be joined by seven new networks that will expand PCORnet’s capacity to conduct studies on a wide range of health topics and questions affecting multiple patient populations.

The new partner networks bring additional expertise, resources, and patient participation focused on Alzheimer’s disease and dementia, autism spectrum disorders, heart disease, obesity, Parkinson’s disease, behavioral health disparities among low-income populations, and health disparities among sexual and gender minorities, among other areas.

Together, the 34 PCORnet partner networks cover more than 150 conditions and a wide variety of population groups. Many of the networks involve multiple organizations, giving PCORnet sites in every state nationwide. A list of all partner networks can be found at pcori.org/pcornet.

“Having key stakeholders — researchers, patients, clinicians, and health systems — working together to co-create PCORnet has been a tremendous step forward in how we approach health research,” said PCORI Executive Director Joe Selby, MD, MPH. “We’re proud of the achievements of the participating individuals and organizations that have worked so diligently to prepare PCORnet to begin conducting robust and efficient patient-centered research.”

“Our main goal for the next three years is to sharply ramp up PCORnet’s capacity to serve as the platform for rapidly and efficiently conducting high-quality, patient-centered studies,” said Rachael Fleurence, PhD, Director of PCORI’s Comparative Effectiveness Research Methods and Infrastructure Program. “We’ll continue to facilitate a national conversation about what it means to share health data and the roles we all have in addressing the health questions and outcomes that matter most to patients.”

PCORnet integrates health data for studies and catalyzes research partnerships among two types of networks: Clinical Data Research Networks (CDRNs), which are based in healthcare systems such as hospitals and health centers, and Patient-Powered Research Networks (PPRNs), which are run by groups of patients and their partners who are focused on one or more specific conditions or populations and are interested in sharing health information and participating in research. With the addition of the new networks, PCORnet’s collaborative “network of networks” now consists of 13 CDRNs and 21 PPRNs.

During the next three years, the participating networks are expected to demonstrate their capacity to support large multi-network studies, both randomized and observational, as well as rapid-cycle studies and other types of research using standardized data sets with strong patient privacy and security protections. In addition, the partner networks are expected to significantly increase their collaborations and to develop plans for sustaining their operations beyond the end of this phase.

The funding awards to the 34 partner networks have been approved by PCORI’s Board pending completion of a business and programmatic review by PCORI staff and negotiation of a formal award contract. With these awards, PCORI has now approved or awarded over $250 million for PCORnet to support the partner networks and their coordination as well as the first of several demonstration research studies.

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Contact: Christine Stencel, Associate Director of Media Relations (202-570-9275 or [email protected])

About PCORI
The Patient-Centered Outcomes Research Institute (PCORI) is an independent, nonprofit organization authorized by Congress in 2010. Its mission is to fund research that will provide patients, their caregivers, and clinicians with the evidence-based information needed to make better-informed healthcare decisions. PCORI is committed to continually seeking input from a broad range of stakeholders to guide its work. More information is available at www.pcori.org.

About PCORnet
PCORnet, the National Patient-Centered Clinical Research Network, is an innovative initiative of the Patient-Centered Outcomes Research Institute (PCORI). The goal of PCORnet is to improve the nation’s capacity to conduct comparative clinical effectiveness research efficiently by creating a large, highly representative network for conducting clinical outcomes research that directly involves patients in the development and execution of the research.

PCORnet focuses on improving capacity to conduct CER through research network

Biosample Buzz; June 2015

As part of PCORnet, task forces were established to support and disseminate best practices. The goal of the Biorepository Task Force is to develop and foster systematic approaches that support a regulatory-compliant, comprehensive, and sustainable Network-wide approach to biorepositories to serve PCORnet research endeavors. The task force includes over 40 members, representing all CDRNs and PPRNs and a patient representative. The Biobank Sustainability work stream recently produced a guidance document addressing biobanking sustainability, and an Informed Consent guidance is currently under review by PCORI. Other work streams include Informed Consent, Biorepository Operations & Logistics, Biospecimen Annotation & Data Transfer, and Governance & Collaborations.

Read more …

Precision Medicine Initiative Public Workshop – May 28-29

Precision Medicine Initiative (PMI) Working Group of the Advisory Committee to the NIH Director (ACD)

Digital Health Data in a Million-Person Precision Medicine Initiative Cohort

Thursday, May 28 – 8:30 a.m.-5:30 p.m. CT
Friday, May 29 – 8:30 a.m.-12:30 p.m. CT
Videocast: Precision Medicine Public Workshop

The workshop will focus on solutions to challenges in the design, composition, and organizational characteristics of a national research cohort of one million or more volunteers.

Find out more …

Best Practice Session Sharing: Chunhua Weng, PhD – May 27

Architecture-Specific Considerations and Methods for Data Quality Assessment in Collaborative Clinical Data Research Networks

Presenter: Chunhua Weng, PhD
Associate Professor, Department of Biomedical Informatics
Columbia University, New York, NY

Wednesday, May 27, 2015
2:00-3:00 p.m. ET
Hosted by the PCORnet DSSNI Task Force

Agenda:
Introduction by Lesley Curtis, PhD, DSSNI Co-chair
Topic: Architecture-Specific Considerations and Methods for Data Quality Assessment in Collaborative Clinical Data Research Networks
Facilitated Discussion (moderated by Lesley Curtis)

Webinar information:
Phone: 1-855-244-8681 (toll-free) or 1-650-479-3207 (toll)
Access code: 738 828 471
Online: https://dukemed.webex.com/dukemed/j.php?MTID=m2d150d2cee39f9982656fe54c900250f

Best Practice Session Sharing: Matthew Roe, MD – May 20

Clinician engagement in pragmatic research: From evolving roles and responsibilities to emerging opportunities for physicians and others!

Presenter: Matthew Roe, MD
Duke University Medical Center, Duke Clinical Research Institute
Wednesday, May 20, 2015
1:00-2:00 p.m. ET

Note: This topic is presented twice (May 20 and May 21) to accommodate the availability of audience members. Attendance at both is not necessary, though audience questions and speaker experience will vary.

Agenda:
Introduction by Rebecca Wilgus, MSN
Topic: Clinician engagement in pragmatic research: From evolving roles and responsibilities to emerging opportunities for physicians and others!
Facilitated Discussion (moderated by Rebecca Wilgus, MSN)

Webinar information:
Phone: 1-855-244-8681 (toll-free) or 1-650-479-3207 (toll)
Access code: 735 488 707
Online: https://dukemed.webex.com/dukemed/j.php?MTID=maa81474f7febc5188cc60064b161ac85

PCORI Awards $14 Million to Determine Best Aspirin Dose to Protect Patients with Heart Disease

First PCORnet Demonstration Study Could Help Guide Treatment Options for Millions

WASHINGTON, DC [May 4, 2015] – The Patient-Centered Outcomes Research Institute (PCORI) Board of Governors today approved a three-year, $14 million clinical trial designed to determine the best dose of aspirin to use to prevent heart attacks and strokes in people with heart disease.

The study, called ADAPTABLE (Aspirin Dosing: A Patient-centric Trial Assessing Benefits and Long-term Effectiveness), will compare the benefits and harms of a low- and regular-strength daily dose of aspirin in patients diagnosed with heart disease. It is the first demonstration project to be conducted through PCORnet, the National Patient-Centered Clinical Research Network, which PCORI is developing to enhance the nation’s capacity to conduct much-needed health outcomes studies more quickly and efficiently, less expensively, and with greater potential impact than is now possible.

“Aspirin has been used for more than 40 years to prevent heart attacks and strokes in people diagnosed with heart disease, but the best dose has yet to be determined,” said PCORI Executive Director Joe Selby, MD, MPH. “We know aspirin can help, but we also know it can cause serious side effects, such as increased bleeding. So we’re very pleased to fund a study designed to answer this question. We’re especially pleased to do so as a way to demonstrate the power of PCORnet to recruit trial participants more efficiently and potentially generate results faster than would be possible otherwise.”

“We’re excited to be part of the first trial conducted through PCORnet,” said Adrian F. Hernandez, MD, MHS, Director of Outcomes and Health Services Research at the Duke Clinical Research Institute and the study’s co-principal investigator. “Heart disease is the leading cause of death for men and women in the United States. The results of this study, to be conducted in a variety of clinical settings, will help patients and those who care for them make better decisions about how aspirin therapy might be most helpful.”

An estimated 15.4 million Americans have coronary heart disease, most of whom take either a regular-strength (325 mg) or a low-dose (81 mg, or “baby aspirin”) dose daily as recommended by their clinicians. However, there is conflicting evidence about the potential benefits and risks of different doses. Regular-strength aspirin has been associated with a greater risk of bleeding in the gastrointestinal tract, but it’s unclear whether low-dose aspirin is both safer and as effective for patients with heart disease.

ADAPTABLE will be led by researchers at Duke and involve researchers, clinicians, and patients from six of PCORnet’s clinical data research networks (CDRNs), each made up of multiple large healthcare systems. The six are: Chicago Area Patient-Centered Outcomes Research Network (CAPriCORN), based at the Chicago Community Trust; Greater Plains Collaborative CDRN based at the University of Kansas Medical Center, Kansas City, Kansas; Louisiana CDRN, based at the Louisiana Public Health Institute, New Orleans; Mid-South CDRN, based at Vanderbilt University, Nashville; New York City CDRN, based at Weill Medical College of Cornell University; and PaTH: Towards a Learning Health System in the Mid-Atlantic Region, based at the University of Pittsburgh. In addition, the Health eHeart Patient- Powered Research Network, based at the University of California, San Francisco, will support the trial by providing a secure patient portal for data collection.

The trial will randomly assign 20,000 patients who have had a heart attack or have significant blockage of their coronary arteries to use a daily aspirin dose of 81 mg or 325 mg. Patients will be enrolled over 24 months, with a maximum follow-up of 30 months. The trial will be conducted in two stages, starting with a six-month protocol development and refinement phase. On the basis of a review of phase one activities, PCORI will decide whether the study will proceed to the implementation phase.

The study is designed to provide patients and providers detailed information about aspirin therapy given patients’ personal characteristics, conditions, and preferences. Researchers also will compare the effects of aspirin in certain patient populations based on gender, age, and racial- and ethnic-minority affiliation and in patients with and without diabetes or chronic kidney disease.

ADAPTABLE is a pragmatic trial, designed to ensure that its results reflect “real‐world” medical practice. Instead of being conducted in specialized research centers under optimized conditions, it will be conducted in a variety of clinical settings among a broad population and range of patients, healthcare systems, and practices. This is possible because the trial will use PCORnet’s vast “network of networks,” each of which engages a variety of patients, providers, and health systems working together to harness the power of health data for clinical research.

To facilitate more efficient recruitment, the trial aims to enroll patients via a unique patient-friendly web portal (Health eHeart) and use a patient-friendly electronic informed consent and information process. Paper-based consent material will also be available as needed.

ADAPTABLE will be the first of several demonstration projects designed to test PCORnet’s capacity to conduct comparative effectiveness and other types of research. PCORI invested $93.5 million in December 2013 to support the development and expansion of 29 individual health data networks that make up PCORnet. These include 11 CDRNs, based in large health systems, and 18 Patient-Powered Research Networks (PPRNs), based in a range of patient groups. PCORI plans to offer up to an additional $150.7 million to support further development of PCORnet.

The award to support the aspirin trial was approved by PCORI’s Board pending completion of a business programmatic review by PCORI staff and issuance of a formal award contract.

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About PCORI

The Patient-Centered Outcomes Research Institute (PCORI) is an independent, nonprofit organization authorized by Congress in 2010. Its mission is to fund research that will provide patients, their caregivers, and clinicians with the evidence-based information needed to make better-informed healthcare decisions. PCORI is committed to continually seeking input from a broad range of stakeholders to guide its work. More information is available at www.pcori.org.

About PCORnet

PCORnet, the National Patient-Centered Clinical Research Network, is an innovative initiative of the Patient-Centered Outcomes Research Institute (PCORI). The goal of PCORnet is to improve the nation’s capacity to conduct comparative clinical effectiveness research efficiently by creating a large, highly representative network for conducting clinical outcomes research that directly involves patients in the development and execution of the research.

Everyone Benefits From Research, But What Are Your Responsibilities?

US News & World Report; April 30, 2015

In his first blog post for US News and World Report, Seth Ginsberg, PI for the AR-PoWER PPRN, describes PCORnet as an emergent opportunity for patients to work more closely than ever before with researchers, leading to a much better understand of health conditions and outcomes.   Ginsberg observes that placing patients and their families at the center of research is an important paradigm shift because traditional methods of conducting health research haven’t focused on the questions and outcomes that matter most to patients, their families, or their doctors.

Read the full article.

Best Practice Session Sharing: Brandon Welch, MS, PhD and Jihad Obeid, MD – May 12

A telemedicine platform for remote electronic informed consent

Presenters: Brandon M. Welch, MS, PhD and Jihad Obeid, MD
Tuesday, May 12, 2015
1:00-2:00 p.m. ET

Agenda:
Introduction by Rebecca Wilgus, MSN
Topic: A telemedicine platform for remote electronic informed consent
Facilitated Discussion (moderated by Rebecca Wilgus, MSN)

Webinar information:
Phone: 1-855-244-8681 (toll-free) or 1-650-479-3207 (toll)
Access code: 730 602 617
Online: https://dukemed.webex.com/dukemed/j.php?MTID=mb1158234a554298cef20ba0be7bdc01c

Best Practice Session Sharing: Thomas W. Carton, PhD, MS – May 6

PCORnet Best Practice Session Sharing

Presenter: Thomas W. Carton, PhD, MS
Wednesday, May 6, 2015
11:00 a.m.-12:00 p.m. ET
Hosted by the PCORnet DSSNI Task Force

Agenda:
Introduction by by Keith Marsolo, PhD, DSSNI Co-Chair
Topic: “Pragmatic Trial App Suite: Supporting patient engagement, trial recruitment and more”
Facilitated Discussion (moderated by Keith Marsolo, PhD)

Webinar information:
Phone: 1-855-244-8681 (toll-free) or 1-650-479-3207 (toll)
Access code: 730 631 138
Online: https://dukemed.webex.com/dukemed/j.php?MTID=m51e18f2f738822c0fef71e8d92c14816

Best Practice Sharing Session: Abel Kho, MD – April 29

PCORnet Best Practice Session Sharing

Presenter: Abel Kho, MD
Wednesday, April 29, 2015
11:00 a.m.-12:00 p.m. ET
Hosted by the PCORnet DSSNI Task Force

Agenda:
Introduction by by Keith Marsolo, PhD, DSSNI Co-Chair
Topic: “Design and development of an operational privacy protecting record linkage tool”
Facilitated Discussion (moderated by Keith Marsolo, PhD)

Webinar information:
Phone: 1-855-244-8681 (toll-free) or 1-650-479-3207 (toll)
Access code: 732 152 931
Online: https://dukemed.webex.com/dukemed/j.php?MTID=m2b8eae261e528b1b17fdff0796d677d1