All posts by [email protected]

Drawing on Mental Health “Experts-by-Experience”

Two leaders, Drs. Andrew Nierenberg and Roberta Tovey, of PCORnet’s Patient-Powered Research Network (PPRN), MoodNetwork, share their thoughts and excitement in a PCORI Guest Blog about the purpose, history, and impact of MoodNetwork, which is committed to changing how mood disorders are understood and treated in our society.

When it comes to depression and bipolar disorder, doctors and therapists have little evidence to predict which treatments will work for which people. And patients’ wealth of experience about their own disorders has often been overlooked. MoodNetwork, formed by researchers, patients, and other stakeholders, is a group of thousands of people with the disorders who can learn from each other and help clinicians figure out the best treatments for individuals.

PCORnet Leaders Participate in Policy Roundtable to Advance the Use of Real-World Evidence

Update 24 June 2016:  The Bipartisan Policy Center has issued the findings from the below Roundtable in a new report entitled Using Real World Evidence to Accelerate Safe and Effective Cures.

On May 25th 2016, PCORnet leaders Adrian Hernandez and Russell Rothman were invited to participate in a Bipartisan Policy Center roundtable focused on advancing the generation and use of real-world evidence.  The event was moderated by Andrew von Eschenbach, MD, former Commissioner of the Food and Drug Administration (FDA), and current President of the Samaritan Health Initiatives, Inc. The roundtable welcomed thought leaders from across industry and academia, including Amgen, Pfizer, Robert Wood Johnson Medical Group, and Duke, Columbia, and Yale Universities. Information generated from the roundtable and other activities, including interviews will multiple other members of PCORnet, will inform a final set of policy recommendations to be released by the Bipartisan Policy Center in late June. The roundtable is part of an effort led by the BPC on “FDA: Advancing Medical Innovation”, co-chaired by Former Senate Majority Leader Bill Frist (R-TN) and Former Congressman Bart Gordon (D-TN).

Goals of the effort include:

  • Improve the medical product development process
  • Increase regulatory clarity
  • Strengthen FDA’s ability to carry out its mission
  • Increase investment in medical products to address unmet and public health needs

To date, the policy center has issued a report and letter to guide the generation and use of real-world evidence, with additional recommendations planned.  PCORnet is excited to be involved in shaping these recommendations as we establish our ‘network of networks’ and leverage real-world data from the more than 110 million lives captured in PCORnet to support a learning U.S. healthcare system and enhance the quality and efficiency of large-scale clinical research.

Stay tuned for a public meeting on June 23 when the Bipartisan Policy Center will release findings from this roundtable.

Update 09 June 2016:  Register to attend the public follow-up meeting, entitled Using Real World Evidence to Accelerate Safe and Effective Cures, on June 23rd,  where Dr. Adrian Hernandez will be speaking.

ADAPTABLE Study protocol posted for stakeholder review

Review and provide comments on the ADAPTABLE study research protocol.  ADAPTABLE is  the first demonstration project to be conducted through PCORnet.  ADAPTABLE is based on a model of sharing knowledge and provides a unique opportunity to engage and collaborate with physicians, patients, patient representatives, investigators, research study team members, and support staff.