Patient-
Centric

Patients, and those who love and care for them, are integral to all phases of research. Patients and caregivers are members of PCORnet’s governance, participate on its committees, and provide valued input and leadership in all facets of the development and execution of PCORnet’s research efforts.

The Mission

Conduct patient-centered and data-enabled clinical research to deliver results that matter, faster.

 

The Vision

Create a sustainable network that conducts patient-centered research and answers questions important to patients, caregivers, clinicians, and the broader healthcare community.

What does PCORnet mean by patient-centered research?

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PCORnet’s patient-centered approach means that it:

Uses a research model that engages patients, caregivers, clinicians, and health systems as partners — alongside researchers — in the conceptualization, design, and conduct of studies and in the dissemination of results.

Prioritizes research that answers key questions that improve the ability to deliver appropriate care which leads to improved outcomes for individuals, communities, and their clinicians and healthcare systems.

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Benefits for Patient Partners

Setting the Research Agenda

Patient advocates are active in prioritizing research questions and setting the research agenda.

Collaborating in All Phases of Research

Patients contribute to study designs, making clinical research less burdensome and identify outcomes that matter to them.

Participating in Clinical Research

Study participants report positive experiences in contributing to research that leads to improved clinical answers.

Acting on Research Findings

Patients drive adoption of actionable findings and changes in clinical care.

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Patient-Centered Model

This Patient Partnership Framework brings PCORnet’s mission to life and keeps patients at the center of everything this Network of Network does.

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Patient Partnership Framework Goals:

Establish broad communication and connection with patient communities

Include patients at all levels of governance

Ensure patient partnership at all stages of research

Develop an evidence base around patient engagement

Provide technical assistance for patient partnership

Share best practices via patient partnership affinity group

Communicate study results to participants

Facilitate patient awareness of data uses

Deep Patient Involvement

The Evolution of Patient-Centricity

PRE-2000

The AIDS epidemic of the 1980s and 1990s spurred the birth of an advocacy movement that catalyzed the creation of patient-driven clinical trial designs, regulatory reform to speed access to new drugs, and increased funding for research. Other patient groups soon picked up this playbook and themselves became major forces in shaping research.

DEC 2009

FDA publishes guidance for industry for the use of patient-reported outcome measures in medical product development to support labeling claims.

MAR 2010

The Patient-Centered Outcomes Research Institute (PCORI) is established to improve the quality and relevance of evidence available to help patients, caregivers, clinicians, employers, insurers, and policy makers make better-informed health decisions.

 

MAY 2012

The Agency for Healthcare Research and Quality (AHRQ) releases the Registry of Patient Registries (RoPR), providing a searchable central listing of patient registries to improve transparency and access to information about registries.

JUL 2013

The Prescription Drug User Fee Act (PDUFA V) is reauthorized, enabling FDA’s Center for Drug Evaluation and Research (CDER) and Center for Biologics and Research (CBER) to initiate a series of Patient-Focused Drug Development (PFDD) meetings to more systematically gather patients’ perspectives on their condition and available therapies.

SEP 2013

FDA’s Center for Devices and Radiological Health (CDRH) launches the Patient Preference Initiative to “develop a systematic way of eliciting, measuring, and incorporating patient preference information, where appropriate, into the medical device Total Product Life Cycle.” FDA guidance for industry, FDA staff, and other stakeholders is released in August 2016.

DEC 2013

PCORI invests more than $250 million in the development of PCORnet designed to empower people to make informed healthcare decisions by enabling clinical research that is faster, easier, less costly and, most importantly, more relevant to their needs.

DEC 2016

The 21st Century Cures Act is enacted, including several key provisions such as the inclusion of patient experience data with drug approvals, new review mechanisms for the use of biomarkers in clinical trial design for new drugs, and the use of real world evidence for support of new drug indications.

AUG 2017

PDUFA V is reauthorized, reinforcing FDA’s CDER commitment to advancing the development of drugs for rare diseases and capturing the patient voice in drug development.

DEC 2017

FDA establishes the Patient Engagement Collaborative (PEC), consisting of an outside group of patients and caregivers offering their input into FDA’s patient-centricity efforts.

MAY 2018

National Institutes of Health (NIH) launches the All of Us Research Program, seeking to enlist 1M+ people and committing to engaging participants as partners.

JUN 2018

FDA releases guidance for industry, FDA staff, and other stakeholders on PFDD.

DEC 2018

FDA releases the Framework for FDA’s Real-World Evidence Program, citing PCORnet’s ADAPTABLE study.