PCORI funded the development of PCORnet^®, the National Patient-Centered Clinical Research Network, to make it easier and more efficient to conduct research. PCORnet is made up of Partner Networks that harness the power of large amounts of health data and patient partnerships.

Clinical Data Research Networks (CDRNs) are one type of network supported by PCORI. CDRNs consist of two or more healthcare systems, including hospitals, integrated delivery systems, and federally qualified health centers. Each CDRN transforms data gathered from routine patient care across its participating health systems to a consistent format, the Common Data Model (CDM), to enable rapid response to research-related questions.

PCORI funded Accessible Research Commons for Health’s (ARCH) participation in PCORnet from 2015 to 2019. This report outlines ARCH’s achievements in building its research infrastructure capacity to

1. Create ways to involve patients, healthcare providers, health plans, and health systems in the research process and decision making about the network
2. Continue building the PCORnet CDM to add new types of data, ensure data quality, answer questions and requests, link to data outside the network, and keep data secure and private
3. Create an efficient infrastructure to carry out clinical trials
4. Create rules and guidance to protect people who take part in research studies, keep participants’ information confidential, and examine the risks of proposed studies
5. Work with PCORnet partners and partners outside the network to do research studies, build information systems, and share knowledge and practices
6. Create a plan to fund the network after PCORI funding ends

Network at a glance

Led by Harvard Medical School, ARCH brought together 13 medical centers from across the country. These centers contributed data to help researchers study a wide variety of health conditions.

How does the network operate?

ARCH created a governance committee with the goal of making it clear how all decisions were made and ensuring that many people had input into the decision-making process. The committee’s main responsibilities included overseeing the ARCH research agenda, developing and approving the ARCH strategic plan, and voting on proposed policies and processes.

This committee was made up of leaders from each medical center partner, another member who represented patients’ viewpoints, and the heads of other network committees. ARCH made agreements with each medical center partner on how to use and share data. A single Institutional Review Board, or IRB, made sure studies were ethical and protected participants.

ARCH made sure network partners stored patient data securely and followed strict security rules. It also ensured that data used to answer research questions could not be used to identify patients.

How did the network involve patients and other partners?

In every part of its work, ARCH involved patients, families, and caregivers; healthcare providers; researchers; healthcare system administrators; health advocacy groups; and Patient-Powered Research Networks (PPRNs), which are networks that are operated and governed by patient groups and their partners and that are focused on particular conditions or populations.

Together a patient and a medical care provider led the network’s engagement committee. This committee created policies and activities to increase involvement from people such as patients, families, and caregivers. The network made sure that all studies that use ARCH data include a plan that outlines how patients will be involved in the study. The network also used citizen scientists and patient liaisons who gave ideas on how to involve patients in research studies. ARCH held a meeting each year that brought together the leads from each partner site, network committee members, patient liaisons, and other people interested in ARCH to develop plans to improve the network.

Who is in the network?

As of June 30, 2019, the network had data for 2,108,824 people who received care through a partner network hospital or clinic. Data sources included electronic health records, patient-reported outcomes, and Medicare and Medicaid data. ARCH developed processes to check data and improve data quality. All partner sites supplied data using the Common Data Model. Data are available from January 1, 2010.

How is the network supporting research?

While a Partner Network in PCORnet, ARCH participated in 25 research projects. The network also collaborated with two PPRNs.

How does the network support future research?

CDRNs follow PCORI standards to make sure their networks continue after PCORI’s funding ends. CDRNs format their data to the CDM and involve patients and healthcare providers in planning and carrying out research studies. CDRNs also take part in research with other networks in PCORnet and build relationships outside of PCORnet.

Glossary

Clinical Data Research Networks (CDRN): CDRNs are networks that originate in healthcare systems, such as hospitals, health plans, or practice-based networks, and securely collect health information during the routine course of patient care.

Common Data Model (CDM): A CDM establishes a standard way of defining and formatting data.

Institutional Review Board (IRB): A group that follows federal regulations, state laws, and institutional policy to review, monitor, and approve research in order to protect the ethical rights and privacy of the subjects involved.

Patient-Powered Research Networks (PPRN): PPRNs are operated and governed by patient groups and their partners and are focused on particular conditions or populations.

PCORnet: PCORnet is a network of networks that brings together patients, clinicians, researchers, and healthcare systems to share information and participate in research.