PCORnet

PCORnet: “Not your father’s clinical trial network”

Posted on by Gina Uhlenbrauck

“PCORnet: Turning a Dream Into Reality,” an editorial published online this week in the Journal of the American Medical Informatics Association, details the promises of the National Patient-Centered Clinical Research Network (PCORnet):

“Providing accurate answers based on the highest levels of scientific evidence for the majority of unresolved clinical questions is a revolutionary dream shared by patients, providers, payers, health plans, researchers, and policy makers alike. PCORnet, the National Patient-Centered Clinical Research Network, promises a transformative platform that will turn this revolutionary dream into reality.”

The authors describe PCORnet’s patient-centered vision and how its transformative clinical research will be carried out through a national research network. This “network of networks” is designed to include a large, highly representative population. PCORnet will first work to establish data architecture and standards and address key policy questions, followed by the conduct of its first pragmatic clinical trial slated to begin in September 2015.

Editorial authors include NIH Director Dr. Francis Collins, Kathy L. Hudson, PhD, and Josephine P. Briggs, MD.

Institute of Medicine Convenes PCORI-Sponsored Workshop on Integration of Care and Research

Posted on by Gina Uhlenbrauck

Update:

Slides and a workshop summary are now available from the Institute of Medicine website.

On April 23-24, 2014, the Institute of Medicine held a Roundtable on Value & Science-Driven Health Care workshop titled “Health System Leaders Working Towards High Value Care Through Integration of Care and Research” in Washington, DC. The workshop, sponsored by the Patient-Centered Outcomes Research Institute (PCORI), brought together stakeholders from across research networks, health systems, industry, and the patient community to engage on barriers and opportunities in building a continuously learning health system, where routinely collected health data informs improvements in evidence-based care. Eric Larson, MD, MPH, of the Group Health Research Institute chaired the workshop Planning Committee.

Workshop goals included:

  • Fostering the development of a shared commitment, vision, and strategy among health system leaders building a national clinical research network
  • Broadening and deepening health systems’ leadership awareness of the prospects for and from a continuously learning health system
  • Learning from models and examples of productive integration of research with care delivery programs
  • Identifying common issues compelling to health systems leaders related to science, technology, ethics, regulatory oversight, business, and governance
  • Exploring strategic opportunities for executive, clinical, and research leaders to forge working partnerships for progress
  • Considering the approach and desirable outcomes of a meeting of CEO leaders vital to building and sustaining a functional, real-time national clinical research network

One particular focus of the meeting was the recently launched National Patient-Centered Clinical Research Network (PCORnet). Workshop participants included representatives from PCORnet’s Clinical Data Research Networks and Patient-Powered Research Networks. Speakers provided real-world examples of learning health systems and urged leaders to make a business case for the learning health system model. Speed and dissemination of research were discussed as important considerations for patients.

The meeting was open to the public via webcast. Archived meeting presentations will be made available; a link will be provided in an update to this post. Workshop-related tweets can be found with the hashtag #IOMPCORI.

View the workshop agenda and briefing materials.

The Diane Rehm Show Features PCORnet

Posted on by Karen Staman

On Thursday, April 17, The Diane Rehm Show, a nationally syndicated news and call-in program carried on National Public Radio, aired a program titled The Promise and Perils of a New Project to Share Individual Patient Records. Susan Page of USA Today led the discussion on PCORnet: the National Patient-Centered Clinical Research Network, which is supported by the Patient-Centered Outcomes Research Institute (PCORI). Dr. Joe Selby, the executive director of PCORI, describes how PCORnet will take advantage of the incredible quantity of clinical information in electronic health records to conduct much-needed research on the relative effectiveness of different medical devices, drugs, and other medical therapies. Click here for a transcript of this program, or listen to the full episode below:

Listen now: The Promise and Perils of a New Project to Share Patient Records

Grand Rounds (4-18-2014): Data Quality and Transparency Standards

Posted on by Gina Uhlenbrauck

Update:

Archived video and slides from the April 18 Grand Rounds are now available on the NIH Collaboratory Grand Rounds webpage.

This Friday’s NIH Collaboratory and PCORnet Grand Rounds (“Building PCOR Value and Integrity With Data Quality and Transparency Standards: An Introduction and Request for Input”) will be presented by Michael G. Kahn, MD, PhD, professor of epidemiology in the Department of Pediatrics at the University of Colorado Denver. Dr. Kahn is co-director of the Colorado Clinical and Translational Sciences Institute (CCTSI), Translational Informatics Core director for the CCTSI, and director of clinical informatics in the Department of Quality & Patient Safety at The Children’s Hospital.

The Grand Rounds presentation will take place from 1:00-2:00 PM Eastern time on Friday, April 18. Archived video and slides from the presentation will be available early the following week; links to archived material will be provided in an update to this post.

Grand Rounds (4-11-2014): A PCORnet Update

Posted on by Gina Uhlenbrauck

Update:

Archived video and slides from the April 11 Grand Rounds are now available on the NIH Collaboratory Grand Rounds webpage.

Today’s NIH Collaboratory and PCORnet Grand Rounds (“A PCORnet Update”) will be presented by Richard Platt, MD, MSc, professor and chair of the Department of Population Medicine at Harvard Pilgrim Health Care Institute. Dr. Platt is co-principal investigator of the Coordinating Center for the NIH Collaboratory, principal investigator of the Coordinating Center for PCORnet, and principal investigator of the FDA’s Mini-Sentinel program.

The Grand Rounds presentation will take place from 1:00-2:00 PM Eastern time on Friday, April 11. Archived video and slides from the presentation will be available early the following week; links to archived material will be provided in an update to this post.

PCORI Featured in Health Affairs Blog

Posted on by Gina Uhlenbrauck

Joe Selby, MD, MPH, executive director of the Patient-Centered Outcomes Research Institute (PCORI), discusses the promise of PCORI’s research efforts in a recent guest blog post for healthcare policy journal Health Affairs. In his post, Selby explains that PCORI’s mandate is not just to fund comparative effectiveness research (CER) studies that compare multiple therapeutic options, but also to share the results in ways that are meaningful to patients, physicians, and other stakeholders.

Although many of PCORI’s resources are dedicated to supporting CER in reaPatient-Centered Outcomes Research Institute (PCORI) logol-world settings, patient engagement in research is also a cornerstone of PCORI’s efforts. Of the $464 million invested, 62% has been focused on CER, with the rest spread across infrastructure (18%), methods (11%) and communication and dissemination research (8%). PCORI expects to commit $1 billion over the next 2 years to expand their work. As part of their mission, they also hope to improve research methods and build the national capacity for CER.

Grand Rounds (3-26-2014): Why Is the FDA Interested in the Collaboratory and PCORnet?

Posted on by Gina Uhlenbrauck

Update:

Archived video and slides  from the March 26 Grand Rounds are now available on the NIH Collaboratory Grand Rounds webpage.

Photograph of FDA CDER Director Janet Woodcock, MD
CDER Director Janet Woodcock, MD. Photo credit: FDA

The guest speaker for this Friday’s Collaboratory/PCORnet Grand Rounds presentation will be the FDA’s Janet Woodcock, MD. Dr. Woodcock is the current director of the Center for Drug Evaluation and Research (CDER), the division of the FDA primarily responsible for evaluating the safety and effectiveness of both prescription and over-the-counter drugs and biologic therapies marketed in the United States.

The Grand Rounds presentation will take place from 1:00-2:00 PM Eastern time on Friday, March 26. Archived video and slide sets from the presentation will be available early the following week; links to archived material will be provided in an update to this post.

Grand Rounds (3-21-2014): The Use of Social Media in Clinical Research

Posted on by Gina Uhlenbrauck

Update:

Archived video and slides  from the March 21 Grand Rounds are now available on the NIH Collaboratory Grand Rounds webpage.

On Friday, March 21, the NIH Collaboratory and PCORnet Grand Rounds featured a presentation on “The Use of Social Media in Clinical Research” by Stephanie Startz, Associate Director of Digital Strategy for the Michael J. Fox Foundation. The Fox Foundation is a patient-focused nonprofit organization dedicated to finding a cure for Parkinson disease.

In December 2013, the Fox Foundation hosted a Twitter chat (#FoxChat) about challenges in clinical trial recruitment. The foundation’s blog notes that the discussion involved more than 90 participants and more than 600 tweets, making it one of Twitter’s hottest topics during that time. The Twitter chat, a full transcript of which is available online, engaged a diverse audience that included researchers, nonprofit organizations, patients, and patient advocacy groups, demonstrating that the Twitter chat format has the potential to elicit dialogue among these groups.

Ms Startz described the Fox Foundation’s other social media efforts on Facebook, Instagram, YouTube, etc, which have been successful in engaging the patient community and encouraging participation in clinical research. For example, a 3-day campaign on Facebook led to more than 1800 visitors to the Fox Trial Finder website. Advice for engaging patients via social media included being social by sharing stories and videos (not just requests for action), avoiding jargon, and responding to users. The Fox Foundation shares firsthand patient experiences, gives updates on trials, and thanks participants using social media. The Grand Rounds discussion covered issues of privacy and the extent to which social media could potentially play a role in involving patients in research design, not just research participation.