Limit Posts to: News | Blog

PCORnet Colleagues Share Insights to Enhance Drug Review at FDA’s PDUFA Public Meeting

Dr. Adrian Hernandez and Sharon Terry, co-principal investigators, PCORnet Coordinating Center, attended the U.S. Food and Drug Administration (FDA) Prescription Drug User Fee Act (PDUFA) Reauthorization Public Meeting on August 15, 2016. In alignment with the meeting’s goal to solicit public feedback on the agreement forged between FDA and stakeholders to evolve the PDUFA program to make the drug review process more efficient, Hernandez and Terry voiced their support of the agreement’s efforts toward patient inclusion, real-world evidence use, and rare disease drug development.
Continue Reading

PCORnet Features New Video and News from Partner Network, ImproveCareNow

PCORnet invites you to learn more about our partner network, ImproveCareNow, by watching our latest video featuring Dr. Peter Margolis, Principle Investigator for ImproveCareNow. The Network is transforming care, health and costs for all children and youth with Crohn’s disease and ulcerative colitis (collectively known as Inflammatory Bowel Disease or IBD).
Continue Reading

Use of Electronic Health Records, Patient Reported Outcomes, and the Common Data Model to Transform Clinical Trials

“PCORI is investing over $300 million into a clinical research network that will unite patients, clinicians, health systems, and EHRs,” says Dr. Adrian Hernandez, associate director of the Duke Clinical Research Institute. “The network itself has medical information and data on over 100 million subjects, and the patient EHRs are mapped to the PCORnet Common Data Model (CDM), which essentially organizes data into a standard structure.” ADAPTABLE will be the first pragmatic clinical trial to use the network. The trial will select patients via their EHRs, reach out to them electronically, consent them electronically, and then follow up with them electronically.
Continue Reading

PCORnet’s MoodNetwork to Lead $4 Million Research Study Comparing Stress Management Approaches

Patient-Centered Outcomes Research Institute Funds Project as a Demonstration of PCORnet. A team of patient and stakeholder partners and investigators from 20 Patient-Powered Research Networks (PPRNs) that comprise PCORnet will take part in a $4 million research project, Healthy Mind Healthy You, to determine the optimal type and frequency of mindfulness-based treatment for managing stress.
Continue Reading

PCORnet leader shares real-world evidence insights at Bipartisan Policy Center panel

The Duke Clinical Research Institute Director of Health Services and Outcomes Research and Co-Principal Investigator for the PCORnet Coordinating Center Adrian Hernandez, MD, MHS, was recently invited to participate in a Bipartisan Policy Center (BPC) roundtable focused on advancing the generation and use of real-world evidence.

The BPC, a nonprofit organization devoted to bipartisan solutions to questions of public policy, hosted the meeting at its headquarters in Washington, D.C. on June 23.
Continue Reading

PCORnet, PCORI’s Health Data Initiative, Commits to Advance White House Cancer Moonshot

WASHINGTON, DC (June 29, 2016) – The Patient-Centered Outcomes Research Institute (PCORI) today announced its support of Vice President Joe Biden’s Cancer Moonshot program to accelerate progress in cancer research and care through a series of commitments by PCORnet, PCORI’s ambitious effort to harness health data and patient partnerships to accelerate the pace and power … Continue reading PCORnet, PCORI’s Health Data Initiative, Commits to Advance White House Cancer Moonshot

Researchers Discuss How One Aspirin Study Can Transform the World of Clinical Trials

Researchers discussed how one of the largest pragmatic clinical trials in history has the potential to transform clinical research at this year’s annual meeting of the Drug Information Association (DIA) in Philadelphia. Adrian F. Hernandez, MD, MHS, Director of Health Services and Outcomes Research, and Lesley Curtis, PhD, Director of the Center for Pragmatic Health Systems Research, spoke during separate sessions about their progress with the ADAPTABLE (Aspirin Dosing: A Patient-centric Trial Assessing Benefits and Long-Term Effectiveness) study.
Continue Reading