Clinical Research Network: JHCRN Infrastructure and Lessons Learned

ABSTRACT

Clinical research studies are becoming increasingly complex resulting in compounded work burden and longer study cycle times, each fueling runaway costs. The impact of protocol complexity often results in inadequate recruitment and insufficient sample sizes, which challenges validity and generalizability. Understanding the need to provide an alternative model to engage researchers and sponsors and bringing clinical research opportunities to the broader community, clinical research networks (CRN) have been proposed and initiated in the United States and other parts of the world. We report on the Johns Hopkins Clinical Research Network (JHCRN), established in 2009 as a multi‐disease research collaboration between the academic medical centers and community hospitals/health systems. We have discussed vision, governance, infrastructure, participating hospitals' characteristics, and lessons learned in creating this partnership. Designed to leverage organized patient communities, community‐based investigators, and academic researchers, the JHCRN provides expedited research across nine health systems in the mid‐Atlantic region. With one IRB of record, a centralized contracting office, and a pool of dedicated network coordinators, it facilitates research partnerships to expand research collaborations among the differing sizes and types of hospitals/health systems in a region. As of August 2024, total 81 studies‐clinical trials, cohort studies, and comparative effectiveness research have been conducted, with funding from the NIH, private foundations, and industry. The JHCRN experience has enhanced understanding of the complexity of participating sites and associated ambulatory practices. In conclusion, the CRN, as an academic–community partnership, provides an infrastructure for multiple disease studies, shared risk, and increased investigator and volunteer engagement.

1. Background

Clinical research is a broad term that includes patient‐oriented studies [1] all the way through large‐database health care delivery research. Research subject recruitment is the cornerstone to successful study conduct [2], and a broad range of patient demographics is often desirable to ensure that the results from such a study are more generalizable to the population at large [3]. As indications for drug approvals become more narrowly defined (e.g., gene mutations in cancer), a very large pool of potential patients is required. However, recruitment into clinical research studies is one of the greatest impediments to successful completion of studies. Enrolling subjects into research studies is becoming increasingly difficult in part because of patient distrust, more complicated study designs resulting in greater patient burden, low public appreciation for the need for study participation, restrictive eligibility requirements, and increased physician workload.

Clinical research networks can play a pivotal role in overcoming these challenges, advancing medical knowledge, and improving clinical care [4]. Although individual studies provide valuable insights, collaborative networks offer several advantages. Existing research has shown that multicenter collaborations enhance the generalizability of findings [5] through the enrollment of a more diverse patient population. Unfortunately engaging multiple institutions may be an obstacle for efficient, and timely completion and approval of ethical, legal, and financially sound studies. Research networks have attempted to develop processes to expedite these procedures [4], but the extensive regulatory environment has been challenging.

There are several clinical research networks that have existed in the past several years [6, 7, 8, 9, 10]. For example, the National Clinical Trials Network (NCTN) [11] is a collaborative network of cancer centers and research institutions working together to conduct clinical trials for several types of cancer. These networks allow for the testing of new cancer treatments and therapies on a larger and more diverse patient population, ultimately accelerating the development of effective cancer treatments. The Clinical and Translational Science Awards (CTSA) Program is a consortium of medical research institutions across the United States funded by the National Institutes of Health (NIH) [12]. It aims to improve the translational research process, bridging the gap between basic scientific discoveries and their application in patient care. CTSA hubs collaborate on multicenter clinical trials, share data, and promote the translation of research findings into clinical practice.

The need for a comprehensive clinical research network (CRN) persists for several reasons. Firstly, health care is evolving rapidly, with emerging diseases [13], complex treatment modalities, and personalized medicine requiring novel research approaches and diverse populations. Secondly, global health challenges demand interdisciplinary and multinational cooperation [14], necessitating networks that can efficiently pool resources and expertise. Additionally, the efficient dissemination [15] of research findings is vital to bridge the gap between scientific discovery and patient benefit. It is not only necessary to address contemporary health care demands but also to ensure that research outcomes translate effectively into improved clinical practices and patient outcomes. We aim to highlight the vision, governance, infrastructure, participating health system characteristics, lessons learned of one such CRN—the Johns Hopkins Clinical Research Network (JHCRN) [16]—and provide guiding principles for establishing new CRN.

2. Rationale for a Multi‐Disease, Multi‐Type Hospital Network

Academic medical centers (AMC) are often the source of investigator‐initiated studies, but these institutions may struggle to attract the volume and diverse pool of patients required for such studies. Although 80% of patients receive their care in community hospitals [17], they are often reluctant to travel to an AMC for research purposes because of travel costs, distrust of large institutions, and the challenges inherent in navigating a new health care system. Thus, AMCs have the expertise and administrative infrastructure to conduct high impact clinical research but need to partner with community hospitals for its diverse patient population and real‐world setting.

Conversely, community health systems and their lead inpatient facilities often lack the administrative infrastructure, scientific expertise, and research infrastructure for the rapid grant submission process or even the active participation in the conduct of clinical trials. They have a larger pool of patients but the ability to provide innovative therapeutics and research opportunities are often limited. Community hospitals/healthcare systems could take advantage of research affiliation with an AMC. This relationship can be used as a marketing tool to better attract and maintain patient loyalty, as well as the recruitment and retention of talented physicians and other healthcare workers.

To overcome this research gap between academic and community hospitals, there is the need to develop a partnership. We take you through the example of one such network developed between community hospitals and Johns Hopkins School of Medicine (JH), an established academic medical center, with an infrastructure to efficiently expand research from an AMC to community hospitals (Table 1). JHU was able to significantly expand the number of study eligible patients as the result of forming the JHCRN. The net result is more research opportunities for all involved including patients. In the era of artificial intelligence and precision medicine, it could be of tremendous help in preparing large datasets [18] for personalized care and development of predication models.

TABLE 1.

Differences in the research capabilities at academic medical centers and community hospitals.

	Academic medical centers	Community hospitals
Access to common medical problems for generalizability	+/−	++
Access to nonurban/ rural areas	−	++
Extensive research administration infrastructure	++	−
Diverse population of research participants	+/−	++
Extensive research faculty expertise	++	−
Pressure to maintain clinical care	++	+++
Procedures in place for protected research time for investigators	++	−
Ability to market themselves as providing most up‐to‐date services	++	−

Note: ++ ➝ present; +/− ➝ sometimes; − ➝ not present; +++ ➝ present all the time.

3. Overview of the JHCRN

The JHCRN is a regional translational research organization linking Johns Hopkins, a pre‐eminent academic medical center, with a diverse network of community‐based health care delivery systems. The mission is to collaborate with the private and public sector to expedite scientific discovery cost‐effectively through clinical trials and comparative effectiveness research to improve patient care and health. This multi‐specialty regional network has been established to circumvent the inherent challenges in conducting clinical research, that is, time delay due to multiple Institutional Review Board (IRB) reviews, identification of collaborating institutions and investigators, fragmentation of data, community investigators without sufficient expertise in clinical research, the infrastructure to conduct clinical trials as well as the ability to access early phase translational research. The overall goal is to provide the appropriate services and infrastructure to address market needs. Key segments of the JHCRN include the following centralized services: single IRB, centralized contracting and budgeting office, standard operating procedures, statistical and secure data management support, and a database of trained investigators over a wide range of institutions. These areas are relevant to most CRNs with similar goals within the United States and abroad.

3.1. Governance of the JHCRN

3.1.1. Governance/Leadership

Johns Hopkins School of Medicine is the central administrative core of the JHCRN (Figure 1). It is housed in the Johns Hopkins Institute for Clinical and Translational Research (ICTR) [19]. The ICTR was originally developed as part of the NIH‐funded Clinical and Translational Science Awards (CTSA's) commitment to community networks and outreach. JHCRN is one out of several avenues ICTR conducts and collaborates on clinical studies internally and externally. The formal head of the JHCRN is the Vice‐Dean for Clinical Research, with operational leadership provided by a JHU‐based Director and a co‐Director from one of the network community affiliate hospitals.

FIGURE 1.

Johns Hopkins Clinical Research Network's (JHCRN) organizational chart.

3.1.2. Committee Structure

There are four standing JHCRN committees that meet regularly: (1) Executive Committee (EC) meets monthly and is responsible for overall network leadership. Members consist of a Director of Research and a Site Network Coordinator (SNC) from each member institution, plus JH administrative research leaders, for example, Director of the JH IRB; (2) Steering Committee (SC), meets quarterly, consists of the Director of Research and SNC from each site, and is responsible for overall strategic development, (3) Investigator Committee (IC) is comprised of the affiliate site research leaders and SNCs, who are responsible for vetting possible network studies and a community member as study project leader. The IC also has lay community representative; and (4) Network Coordinators Committee (NCC) meets weekly with the JHCRN Director. The SNC are experienced nurses, hired and embedded within the affiliated sites with knowledge of the JH research infrastructure. The NCC meets monthly to discuss potential studies, regulatory and contracting updates, and other issues that may arise. This group is responsible for the development of all JHCRN Standard Operating Procedures (SOP).

3.1.3. Requirements for Affiliate Site Membership

The sites need to be from within the United States mid‐Atlantic region, and already have some research activities, yet wish to expand these by collaborating with an academic medical center. Requirements for membership in the network include the following: (1) Clear evidence from the institutional leadership that joining the JHCRN is a priority, (2) personnel employed at the site with adequate expertise and training to do clinical research, and (3) an administrative infrastructure able to legally sign research contracts. Membership requires a yearly fee to support the costs of the JHU centralized infrastructure and dedicated leadership are required to participate in the committee structure of the network. Also, all sites must have a SNC, with availability of approximately half to a full‐time equivalent.

3.1.4. Functional Roles of the Leaders

The Director of Research at each affiliate site, is commonly a physician and sits on the SC, EC, and IC. They are responsible for identifying appropriate researchers at their institutions for specific research studies and ensuring all regulatory, ethical, and contractual procedures are met. The SNC, typically a nurse, also sits on the same committees but has a more daily role communicating with research personnel at the local site and JH. The SNC needs to be familiar with the administrative procedures of both institutions to ensure efficiency and expeditious flow of work.

3.2. Operational Functions

The operational functions of CRN and its benefits are detailed in Table 2. These include affiliate agreement, nondisclosure agreement, clinical trial agreement, study specific agreement, and a prospective reimbursement analysis.

TABLE 2.

Types and function of contracts required in a clinical research network.

Type of agreement	Scope	Frequency	Stakeholders	Description
Research Affiliate Agreement	Binds network sites to terms of NDAs/CDAs executed by AMC Office of Research Administration (ORA)	One‐time	AMC and CRN affiliate site legal office	Allows sharing of protocols across sites without executing multiple CDAs for each site for each protocol
Clinical Trial Agreement	Contract between funding agency and AMC	Per study	AMC ORA and funding agency	Study specific contract with terms from research sponsor to AMC
Study Specific Agreement (SSA)	Subcontract between AMC and CRN affiliate site	Per study	AMC and CRN affiliate site budget office	Unique subcontract detailing scope of work between AMC and CRN affiliate Site
Prospective Reimbursement Analysis (PRA)	Medicare coverage analysis	Per study	AMC ORA and funding agency	Reviews all study costs to determine eligibility for payments

3.2.1. Contracting

Table 2 lists the contracts most frequently executed on behalf of the JHCRN. JH School of Medicine is the legal body of record, based on the affiliate site signing a Research Affiliate Agreement. This agreement states pre‐negotiated terms in which the affiliated sites accept JHU as the IRB of record, JHU can negotiate on their behalf with an outside research sponsor, and that the affiliate will comply with the various policies and procedures of JHU. Additionally, the affiliate sites sign a Master Research Affiliate Nondisclosure Agreement. For each individual study, the primary contract is the Clinical Trial Agreement between a sponsor/funding agency and JHU. The secondary subcontract or Study Specific Agreement (SSA) is executed between JHU and the affiliate site, detailing the scope of work and payment terms for each study.

3.2.2. Budgets

In all studies, the goal is that most, if not all study procedures be conducted at the CRN affiliate site. This is consistent with the understanding that most procedures can be done in the community setting, thus lessening the burden on patients who do not want to travel to the AMC. Money flows from the sponsor via a contract to the AMC (primary contract), followed by a secondary subcontract (Study Specific Agreement) to the CRN affiliated site. The primary budget is created by the central services of the AMC, with final approval by the AMC Principal Investigator (PI). For industry‐funded studies, there is per patient reimbursement plus the start‐up costs for each of the sites. Prior to budget negotiation with a sponsor, all studies undergo a Prospective Reimbursement Analysis (PRA) determining whether items and services provided during the performance of the study should be covered by a study account or billed as routine clinical care costs. Federal funded studies are converted into either per patient costs (reimbursed to each participating site) or direct fee‐for‐service reimbursement for study procedures. The decision regarding per‐patient reimbursement versus salary support for personnel is made on a case‐by‐case basis. For both industry and federally funded studies, the start‐up for training and administration time is budgeted for each CRN affiliate site.

3.2.3. IRB

The AMC IRB is the IRB of record with the capability of adding sites and investigators electronically. Each affiliate site amends their Federal Wide Assurance (FWA) to rely on the AMC IRB. In addition, each affiliate site has a local IRB or research review committee, responsible for conducting an expedited review to ensure alignment with organizational priorities and operations. Adverse events, serious adverse events, protocol deviation reporting, and annual reviews are submitted centrally by the AMC PI to the AMC IRB. Then the CRN affiliate site PI and coordinator submit them to their local IRB.

3.2.4. Communication

The CRN affiliate sites are often located hundreds of miles away, hampering communication. Regular (virtual and in‐person) meetings and informal discussions are held to maintain openness and communications, as well as to ensure PI oversight. In addition to the AMC PI, affiliate site investigators and research coordinators, each study has a SNC, a key role as a site‐specific point of contact for clear and close‐looped communication.

3.2.5. Study Conduct

Subjects are enrolled and receive study interventions at either the AMC or affiliate site. A key ingredient of the Network is to enroll research participants and to perform all research procedures locally. The AMC site often serves as a coordinating center and can provide centralized pharmacy services to all sites. Principal investigators at the AMC oversee all research sites conducting the research.

3.3. Specialty Working Group Committees

3.3.1. Content Specialists

It would be unrealistic for one leader to have all the required expertise. So, it is recommended to have several Associate Program Directors (APD) who would report to the director of the CRN. They should have expertise in their respective areas of excellence. Their role is to advocate for the CRN within their specialties and to review relevant protocols for their feasibility and appropriateness for the CRN. For the JHCRN, there are three APDs—in oncology, population health, and information technology (IT). Their expertise was determined by JCHRN's needs based on the submitted protocols. It could vary for each CRN based on their needs vision and scope.

3.3.2. Information Technology

One of the key aspects of the network is clinical research data collection, management, sharing, analysis, and dissemination for research purposes. The JHCRN has a standing IT committee that tasks itself with developing methods for facilitating data access across multiple sources, including such tools as Research Electronic Data Capture (REDCap) [20], TriNetX, electronic health record systems as well as ensuring timeliness, quality, and efficiency in the use of these data sources for research initiatives across the network sites. The committee also assesses any gaps in data availability and quality with the goal of specific within‐network solutions.

The REDCap or any other suitable data collection form can be developed to ensure standardized data requests from investigators to CRN sites to inform their grant applications. This form ensures that the same data, including International Classification of Disease (ICD) and Current Procedural Terminology (CPT) codes, are pulled to define the study population across the sites to articulate the study research question fully and transparently. If the investigator needs help with making the general research question more specific, they are requested to consult the IT director or the SNC. Some changes to the research question can occur after the investigator assesses the data provided by the sites and wants to narrow down or expand the focus of their study. For this reason, data requests can also be iterative as several potential research questions and study populations can be explored in the planning stage.

The APD for IT in conjunction with the IT committee oversees information technology‐ and data‐related support to the CRN initiatives as well as provides guidance on any developments in this area, including recommended policies, procedures, and resources. The committee develops priorities for more effective collaboration and data integration within the network in support of clinical research. In addition, as the committee lead, the APD for IT advocates for best practices to support faculty's research needs and highlight resources available and new directors in this area.

3.3.3. Data Security

Data Security receives priority oversight at Johns Hopkins. The Data Trust council provides Data Governance of all clinical and research data. The Data Trust provides a peer review of all data management. The guidelines for data management protocols are provided by the data managers' interest group within the Data Trust and include education and information on data management, data security, and best practices. When any study seeks IRB approval, the Data Management plans of these studies must receive Data Trust approval for security and protection of PHI. Any new IT applications used for clinical research must also undergo Data Trust review. The Data Trust also provides the SAFE (secure analytical framework environment), a secure environment to analyze and share sensitive data. The SAFE provides productivity software and services ex: word and excel, REDCap, Open Specimen, clinical research management system (CRMS) [21], Qualtrics and statistical software, for example: SAS, R, R studio and Python. Other software is available as needed. SAFE provides scalable storage with the first 100 GB of storage provided for free.

3.3.4. Quality Assurance (QA)

Regulatory compliance and high‐quality data production are crucial to a successful human subjects' research program. The CRN facilitates human subjects research through a hub and spoke administrative model. Multiple CRN affiliate sites are the spokes and AMC is the hub of distribution of research.

The CRN administrators may find it difficult to develop a traditional QA program that involves a procedure of verifying adherence to research protocols, in‐person site visits by a study monitor for source document review and verification of accurate data entry into an electronic data capture system, and review of adverse event (AE) documentation. This was attempted by the JHCRN and because of financial and educational requirement constraints, in 2020 the JHCRN decided the traditional model of QA was impractical to implement.

As a result of the significant challenges, a model of self‐affirming compliance was designed and modeled after commonly used standard of practice accreditation requirements for professional programs. The new model identified as the JHCRN Clinical Quality Management Plan (CQMP) for investigator initiated clinical research. The JHCRN's CQMP process assures that IRB‐approved human subject protocols comply with applicable regulations and carried out with best practices and that the rights and safety of study participants are protected. The CQMP establishes oversight to ensure that important risks to quality are identified and that mitigation plans are put in place.

3.3.5. Metrics Committee

A metrics committee within a CRN plays a crucial role in ensuring the effectiveness and quality of research endeavors. Comprising experts in data analysis, statistics, and research methodology, the committee focuses on defining, implementing, and monitoring key performance indicators (KPIs) to evaluate the network's research activities. This involves assessing protocol adherence, patient recruitment rates, data completeness, and overall study progress. The metrics committee plays a pivotal role in optimizing research processes, identifying areas for improvement, and providing valuable insights to enhance the efficiency and success of clinical trials within the CRN.

3.3.6. Nursing Research Collaborative Committee

As nursing research grows nationwide [22], the CRN are uniquely situated to conduct multisite research studies led by nurses. Through nursing research collaborative committee monthly meetings, the members of each of the sites act as a think‐tank for the development of research questions, grant writing and study implementation across sites. Topics should be relevant to nursing and focus on community engagement, in‐patient acute care, out‐patient interventions, and nursing administrative issues. Other goals should include education, mentoring and methods to disseminate research findings to advance nursing science.

3.4. CRN Affiliate Institutions

3.4.1. Luminis Health—Anne Arundel Medical Center

Luminis Health is a nonprofit regional health system headquartered in Annapolis, Maryland. Comprised of Anne Arundel Medical Center, Doctors Community Medical Center (DCMC), J. Kent McNew Family Medical Center, Pathways Alcohol & Drug Treatment Center, DCMC Rehabilitation and Patient Care Center, and Luminis Health Clinical Enterprise, the system serves a population of 1.8 million people. Luminis Health has 840 beds, more than 100 sites of care, and 9600 team members. The population served is primarily suburban, with some urban sites in the District of Columbia. Anne Arundel Medical Center was the first affiliate site to join JHCRN in 2009 and have taken part in several studies and enrolled substantial number of patients in these years.

3.4.2. Tower Health—Reading Hospital

Reading Hospital is the flagship academic medical institution of Tower Health, a healthcare system configured around three acute care hospitals and one pediatric hospital in southeastern Pennsylvania. Reading Hospital (RH) is a 697‐bed nonprofit teaching hospital, located in West Reading, Pennsylvania, that has been serving the Berks County region for over 150 years. It primarily serves a rural suburban population, and offers acute care in the hospital, and additional services at the McGlinn Cancer Institute, the Miller Regional Heart Center, the Reading HealthPlex for advanced surgical and patient care, the Emergency Department (designated as a Level I Trauma Center), and Beginnings Maternity Center (Level III Neonatal Intensive Care Unit). Through the Tower Health Medical Group, the organization has a large network of over 700 integrated offices of dedicated specialists and general medical care. Beyond acute care, RH transitions patient care to the Reading Hospital Rehabilitation at Wyomissing and the Tower Behavioral Health. RH has been an affiliate member of the JHCRN since 2012. During that time, investigators for both locations have successfully collaborated on research in several areas, including infectious disease, cardiology, nursing, cancer, diabetes, and women's health and pregnancy. Reading has contributed over 1000 enrolled participants to research studies.

3.4.3. TidalHealth

TidalHealth established over 120 years ago, is the largest organization on the Delmarva Peninsula on the eastern coast of Maryland with nearly 5000 healthcare providers (800+ physicians, physician assistants and nurse practitioners) and employees across the health system. TidalHealth primarily serves a rural population and is comprised of 30+ locations with 24 specialties and is designated as a Level III Trauma Center. The TidalHealth healthcare system provides services to approximately 500,000 people living in seven, mostly rural and agricultural counties in Maryland and Delaware. TidalHealth joined the Johns Hopkins Clinical Research Network in 2012. Since joining the JHCRN, the clinical research capabilities of TidalHealth have expanded rapidly with the addition of a satellite Cancer Center and merging with a cardiology practice actively involved in clinical research for more than two decades. Collaborations with the JHCRN have included trials involving care coordination for cancer survivors, treatment of back pain in rural areas, palliative care in African Americans and participation in a circulating tumor DNA registry.

3.4.4. WellSpan Health

WellSpan Health serves the communities of south‐central Pennsylvania and northern Maryland. The organization comprises of more than 22,000 employees and 220 patient‐care locations. There is total of eight respected acute care hospitals (total inpatient beds > 2000) serving York, Adams, Lebanon, Lancaster, and Franklin counties Pennsylvania. There are approximately 2.2 million patients within the health system, with a catchment area of over three million. They primarily serve a rural/suburban population. At WellSpan Health, there is a multispecialty medical group that employs over 2600 physicians and advanced practice providers. It has a Joint Commission‐accredited Comprehensive Stroke Center, a Level 1 Regional Resource Trauma Center, a Level 3 NICU (WellSpan York Hospital and WellSpan Ephrata Community Hospital), a comprehensive Metabolic and Bariatric Surgery Center (MBSAQIP‐accredited), central Pennsylvania's most comprehensive behavioral health organization and a home care organization. It has five regional cancer centers and participates in oncology trials through the National Clinical Trial Network (NCTN) of the NCI. WellSpan Health joined the JHCRN in 2021 and participated in seven studies and trials and enrolled a total of over 100 patients.

3.5. The Johns Hopkins Medical Institutions

The Johns Hopkins Medical Institutions (JHMI) in Baltimore, MD, has a 125‐year history rooted in excellence and discovery. Modern medical education was born and revolutionized at Johns Hopkins University, and it has been the home of physicians and scientists who have contributed countless advances in medicine. The Johns Hopkins Medicine vision is to push the boundaries of discovery, transform health care, advance medical education, and create hope for humanity.

Johns Hopkins Medicine (JHM) is a $9.7 billion integrated global health enterprise and one of the leading health systems in the U.S., with more than 3500 active research protocols and over 2400 medical faculty and 50,000 employees. The JHM health system includes 2 major academic teaching hospitals and 3 community hospitals that account for 2365 inpatient beds, nearly 115,000 annual discharges, and 337,100+ emergency department visits. JHM is also comprised of Johns Hopkins HealthCare, a managed care plan covering more than 467,100 people; Johns Hopkins Community Physicians, a network of over 40 primary and specialty care outpatient sites, handling more than 930,000 annual patient visits; and Johns Hopkins Home Care, a full‐service home care provider with nearly 150,000 patients served.

Table 3 highlights the size, catchment area, resource, and system level patient volume data of JHCRN affiliate sites.

TABLE 3.

JHCRN affiliate site resource and system level patient volume data.

Health systems	Johns Hopkins	Luminis Health	TidalHealth	Tower Health	WellSpan Health
Representative hospitals	Johns Hopkins Medicine Johns Hopkins Baltimore Bayview Medical Center Sibley Hospital Howard County Suburban Hospital	Anne Arundel Medical Center Doctors Community Medical Center	Peninsula Regional Nanticoke	Reading Hospital	York Hospital
Locations—City and state	Baltimore suburbs and the capitol region	Annapolis, MD	Salisbury, MD	Reading, PA	South Central PA
Service area population
Service area population	1,472,185	2,298,705	637,871	2,185,304	1,412,459
System‐level resource data
No. of Providers—MD, DO, PA, & NP	5800+	1800+	735	710	2600+
Total FTE's—FY a 2022–2023	50,000+	6700+	2622	10,000+	22,000+
Licensed beds	2372	555	405	697	1499
System‐level patient volume, FY 2022 a
Adult admissions	95,500	32,146	19,149	39,450	68,424
Infant deliveries	10,000+	5660	2826	4105	6577
Emergency room admissions	337,100	141,306	104,314	156,300	265,637
Outpatient visits	931,200	416,967	769,800	612,100	1,996,386

^a FY counted from July to June.

4. Funding Sources of Studies Conducted Through the JHCRN

4.1. Investigator‐Initiated Grant Funded Research

Investigator‐initiated grant‐funded research should be the primary focus of the CRN. All investigators must present to the Investigator Committee (IC) for early vetting to refine and strengthen their protocols and determine study feasibility at the CRN affiliate sites.

For JHCRN, a total of over 140 studies have been presented to the (IC) for early vetting to refine and strengthen their protocols and determine study feasibility. Since 2009 the JHCRN has been a part of more than 81 grant‐funded studies, including the federal sources of the Patient Centered Outcomes Research Institute (PCORI), the National Institutes of Health, the Multiple Sclerosis Society, and Susan G. Koman Foundation. By design, the JHCRN is a multi‐disease network, with studies in the areas of oncology, endocrinology, critical care, and multiple sclerosis.

4.2. Industry Funded Research

The CRN should participate in pharmaceutical studies utilizing the network model. Not all studies assessed by the network may be a match for all sites; early phase or rare diseases are typically managed within the academic setting, while post‐market studies are often a better fit for affiliate hospitals. The community sites may not be enthusiastic about participating in pharma‐sponsored studies as they may perceive that they could better negotiate per patient and start‐up reimbursement than being part of CRN. One of the industry site alliances' benefits is the ability to identify studies for the CRN and grow the individual research efforts at the affiliate site level. This allows the affiliate sites to obtain research otherwise not realized. The JHCRN has successfully participated in 14 pharmaceutical studies utilizing the network model.

4.3. Research Accelerator and Mentorship Program (RAMP) Grant

One of the major advantages of the CRN is to enhance quality research via affiliate site mentoring along with networking, receiving feedback on protocols, budgeting, and grant writing assistance. This could be done via focused mentoring programs and grant mechanisms. In 2015, the JHCRN established the RAMP grant to promote collaborative research across its institutions. The JHU School of Medicine provided funding for peer reviewed proposals to stimulate research collaborations across the JHCRN that were focused on clinical and community‐based, practice‐based, and health services research. Both JHU and JHCRN affiliate site researchers were eligible to apply for funding. Figure 2 includes a small survey data from JHCRN investigators. In this survey, investigators reported 80%–90% value with access to network sites, opportunities to collaborate, networking, and budget assistance. The perceived value of presentation of ideas and feedback, single IRB, and grant writing assistance were between 60% and 80% range.

FIGURE 2.

JHCRN resources: Services available to investigators from the JHCRN and its perceived value (these results are based on limited pilot survey respondent sample with 34% [N = 12] response rate).

5. Types of Studies Through the CRN

A wide variety of studies could be conducted through a CRN. They can range from population health, community intervention to clinical trials. In JHCRN at the time of writing of this manuscript type of research selected examples are listed in Table 4. By definition, a JHCRN study is any study involving JHU and at least one affiliate site.

TABLE 4.

Examples of key studies being done through the JHCRN from 2017 to 2022.

Abbreviated title	Type of research	Funding source
Maryland's Statewide Suicide Data Warehouse	Population Health	NIMH
Effectiveness of fully automated digital health for diabetes	Clinical trial	NIDDK
Community health intervention for disparities in palliative care	Community intervention	NCI
COVID‐19 survivors and families	Population Health	PCORI
Cancer disparities	Community trials	Merck Foundation
Wearable devices to detect COPD	Clinical trial	SBIR
Shared decision making and medications	Database	K‐award
Circulating tumor DNA	Specimen collection	NIH
Biofilm epidemiology and colon cancer	Specimen collection	NIH

6. KPIs

Every CRN should measure their relevant KPI, which may include studies presented to the Investigator Committee for possible collaboration, letters of support provided to grant submissions, unique and repeat investigators engaging with the CRN, grants funded, sites participating in each study, total grant funds received, total grant funds received by, affiliated site, and protocol deviations/FDA audits etc. Affiliate sites are measured for these KPIs. Also, there are annual presentations from the affiliate site, showcasing their participation, opportunities, and areas for growth. The discontinuation of sites is based on affiliates and academic sites higher leadership's mutual decision after first 2 years of contract and thereafter, upon annual renewals.

7. Potential Challenges and Lessons Learned From CRN Development

There are multiple challenges in building a CRN, these could be unique to each CRN affiliate site, while other challenges could be similar throughout CRN affiliate sites (Table 5). The greatest challenge could be building trust among AMC and CRN affiliate site investigators and SRC. This could be overcome with monthly teleconferences across sites, standardized staff training programs, compliance with CRN wide standard operating procedures, and targeted introductions to collaborators at sites. This could also help with negating hesitancy among AMC investigators to participate in industry‐funded studies because of excessive time [23] required for full approvals.

TABLE 5.

Challenges and mitigation strategies in CRN at AMC and affiliate sites.

AMC challenges	CRN affiliate site challenges	Mitigation strategies
Sharing a clear CRN vision, budget requirements, and gaining trust	Time taken to build trust and sharing the AMC vision	Clear communication of roles, finances, and buy‐in at CRN affiliate site leadership
Unfamiliarity with competency of community investigators	Inexperience with research	Regular conference calls, identification of a mentor/mentee, and research education
Insufficient and bureaucratic research infrastructure	Limited research infrastructure	Emphasize the need for investment
Unaware of CRN resources	Unaware of relationship with AMC	Website advertising and faculty interaction
Limited research coordinator personnel	Limited research coordinator personnel	Research coordinator pool for shared resources
Inability to identify interested investigators for industry‐funded studies	Unable to identify interested collaborators for Investigator‐initiated studies	Identify incentives including protective time, sharing of indirect/direct funding

Another challenge facing CRN affiliate site investigators is the absence of dedicated time to participate in research [24]. Potential investigators at affiliate sites are primarily clinicians who receive their salary based on clinical revenues. Although research is theoretically appealing, there is little incentive to participate in multi‐institutional research. Academic promotions or manuscripts may not be the best motivator in the absence of dedicated research time and no/little access to the research funds [25]. The AMC could emphasize to the CRN affiliate site leadership, that research participation by investigators builds job satisfaction, is a marketing technique to expand clinical referrals and is a necessary component of residency/fellowship training programs.

Additional challenges faced by affiliate sites are the continued investment in personnel to support a relatively small research infrastructure [26]. As research grows there will be some economies of scale, but the initial investment in space, expertise, and personnel can be daunting. Similarly, both the AMC and the affiliate site may be large institutions, with high turnover rates of faculty and staff. There should be attempts to build awareness of the JCRN resource through the internal and external websites and presentations to divisional and department meetings.

Finally, excess time required for the internal regulatory [27] steps could be an ongoing issue and likely increase as the CRN grows. Although it is expected that the CRN would significantly shorten the time interval for the full approval process, this may not be the case for most studies.

8. Future Directions

JHCRNs' vision is to be a premier network of affiliated academic and health care institutions, which engage in innovative, collaborative clinical research to improve the health of individuals and populations. To gain a deeper understanding of how affiliate sites are influenced by JHCRN research, a structured plan will focus on collecting and analyzing objective data. This effort will include developing a comprehensive dashboard to track the total number of studies entering the network and their progression through each stage of the implementation process. Key metrics will highlight studies that encounter barriers, with an aim to identify common challenges that impede site activation. Additionally, the analysis will extend to the procedural aspects of study management at affiliate sites, including the selection, onboarding, and operational phases. Efforts will also examine the broader impact of JHCRN research at these sites, such as the recruitment and training of clinicians, obstacles faced by community‐based practitioners (e.g., limited research time, diminished relative value units [RVUs]), financial models of research, and the capacity of local administrative infrastructures.

This initiative will not only illuminate the operational dynamics of research within the network but also inform strategies to overcome systemic barriers and optimize site participation. The findings will be synthesized in a forthcoming manuscript, offering actionable insights and contributing to the broader discourse on the integration of research within community health care networks. An incoming CRN should be inspirational in their vision and mission to challenge status quo. They should initiate new collaborations with like‐minded institutions and advance the field.

9. Conclusions

In conclusion, clinical research networks have an important role in building partnerships between research leadership from the academic medical center and community hospital systems. The CRN brings much needed resources to community hospital physicians who have chosen to practice in a nonacademic setting that is focused on clinical care but believe their medical practice is enhanced through the conduct of clinical research. The community‐based hospital systems provide the opportunity to bring research to the communities they serve as well as the health care provider trainees who are now able to stay where they live and still have access to the latest innovations in medical care. This article has described the key components of an academic/community hospital research partnership in the mid‐Atlantic region of the USA. Any successful innovative program requires commitment to a set of guiding principles and takes years to build. The CRN culture emphasizes the importance of and respect for personnel and patients from differing health care delivery systems. This vision acknowledges that academic medical centers have ideas, clinician scientists with highly specialized training, and a robust infrastructure to support research; whereas community hospitals often have the broadly diverse patient population and are ideal for asking the most important clinical questions. The mission of a CRN should be to build relationships between researchers and to provide opportunities for individuals at community and rural hospitals to participate and have a voice in studies, rather than being disenfranchised from research.

New initiatives require a buy‐in by leadership at all institutions. Academic medical centers must understand that they need to develop relationships with community hospitals, not only for clinical referrals, but to grow their research portfolios. Community hospitals must understand that research is crucial for the development of training programs, physician satisfaction, and providing opportunities to their local community. This approach requires monetary investment in a research infrastructure and a dedicated vision of cooperation.

Conflicts of Interest

The authors declare no conflicts of interest.