Fostering the Next Generation of HLBS Clinical Trialists

The National Heart, Lung, and Blood Institute (NHLBI), of the National Institutes of Health (NIH), hosted a two-day, virtual workshop on October 17-18, 2023, entitled Fostering the Next Generation of HLBS Clinical Trialists. The purpose was to identify  key competencies for successful clinical trialists, and how current career development training programs may be enhanced to support acquisition of the skills and experience needed to lead future clinical trials in heart, lung, blood, and sleep (HLBS) conditions. Additionally, opportunities to enhance the diversity of HLBS clinical trialists along each stage of career development were discussed. This workshop aligned with Objective 8 of NHLBI’s Strategic vision: Further develop, diversify, and sustain a scientific workforce capable of accomplishing the NHLBI’s mission.

Background

Clinical trials (CTs) are a critical part of the translational science pathway. There’s an urgent need to enhance diversity and inclusion of the clinical trialist workforce, particularly as a strategy for enhancing the diversity of CT participants. Furthermore, the explosion of mobile health/remote technology, electronic health records, and interest in novel trial designs has increased the complexity of conducting CTs. There is increasing emphasis on the need for trials to be cost-effective with significant clinical and/or public health impact. All of these issues have significant implications for the training and career development requirements of the scientific workforce needed to conduct 21st century CTs.

The overall goal of the workshop was to identify opportunities to optimize support for the career development of the future leaders of NHLBI clinical trials. Invited workshop participants discussed several key issues:

• “Core competencies” needed for HLBS clinical trialists to conduct high-impact clinical trials
• Current challenges to learning how to design and implement HLBS focused clinical trials
• Opportunities to enhance skills and experience in the design and implementation of HLBS focused clinical trials
• Aspects of the training environment that support career development of HLBS clinical trialists
• Challenges to and opportunities for enhancing the diversity of HLBS clinical trialists throughout the pipeline

SESSION 1

Testimonials of Successful Transition of Clinical Trialists

Panelists:

• Rebecca Campo, PhD, Division of Cardiovascular Sciences, NHLBI (Moderator)
• Christopher Celano, MD, Associate Director, Massachusetts General Hospital; Associate Professor, Harvard Medical School
• Jada L. Brooks, PhD, MSPH, RN, FAAN, Associate Professor, University of North Carolina-Chapel Hill
• Surya P. Bhatt, MD, MSPH, Professor of Medicine, University of Alabama at Birmingham
• Vilma Irazola, MD, MSc, PhD, Director, Institute for Clinical Effectiveness and Health Policy (IECS)

Early stage investigators (ESI) achieve CT experience typically by conducting a pilot study within a mentored training experience such as a career development award (CDA; i.e., K awards). These early CT experiences can generate data to serve as preliminary data for future research applications and ultimately larger independent investigator research awards. These are immersive opportunities to learn about CT study design, methodology, and operations. In this session, investigators shared lessons learned in their transition from mentored CDAs to larger independent investigator single-site and multi-site CTs. Below are strategies identified by panelists to consider for overcoming challenges and to facilitate smoother transitions to conducting independent CTs:

Strategies during the career development award:

• Early diversification of research interests
• Be open and aware of opportunities to engage in as many studies as possible, including cohort studies and industry-sponsored trials
• Be involved in writing protocols and budgets as early as possible gives an important perspective on the operational details of clinical trials
• Seek training in best practices for staffing and retaining study team members, such as research coordinators and program managers
• Learn from challenges in hiring, recruitment, and engagement of community partners in research
• Optimize the study procedures during the career development award, ensuring fidelity to maintain rigor and consistency in the study
• Build a portfolio by publishing either small pilot studies or secondary analysis of randomized controlled trial (RCT) data; these provide early success and early results can contribute to preliminary data for larger trials
• Proactively seek research mentorship and collaborations
• Leverage existing institutional resources for grant writing, budgeting, and recruitment and retention of study staff
• Participate in short-term research training programs focused on cultivating diversity among clinical trialists. Examples of cultivation programs mentioned included NHLBI’s Programs to Increase Diversity among Individuals Engaged in Health-related research (PRIDE), NIMHD’s Health Disparities Research Institute Scholar program, and various institutionally sponsored programs

Strategies for transitioning from single-site to multi-site awards

• Use a team-based approach for designing and conducting trials
  • Important characteristics of successful team members include shared trust and mutual respect, communication skills, and equitable partnerships
  • Have a multidisciplinary team with technical knowledge, operational knowledge, and budgeting skills
• Seek meaningful stakeholder engagement that has different interests, motivations, and influence
• Acquire a deep knowledge of the context in which the clinical trial will be conducted
• Conduct context analysis and identify barriers and facilitators beyond methodological training
• Understand that migrating from a single center study to multi-center study is a big challenge; early participation in a clinical trial network as a fellow or co-investigator can provide valuable experience

SESSION 2

Investigator Diversity: Challenges and Opportunities

Panelists

• Nicole Redmond, MD, PhD, MPH, Division of Cardiovascular Sciences, NHLBI (Moderator)
• Peter Kaufmann, PhD, University of Nevada
• Helen Heslop, MD, DSc, Baylor College of Medicine
• Roxana Mehran, MD, FACC, FAHA, MSCAI, FESC, The Women’s Heart and Vascular Center at Mount Sinai
• Jackson Wright, MD, PhD, Case Western Reserve University
• Girardin Jean-Louis, PhD, University of Miami
• Kate Roskom, MSN, RN, Division of Intramural Research, NHLBI
• Julie Miller, MPH, Carelon Research

The goal of this session was to explore the challenges and opportunities among diverse clinical trialists along several dimensions of diversity: scientific discipline, role on study team, race/ethnicity, and gender.

Disciplinary Diversity in Clinical Trials

This part of the session provided perspectives on the barriers and facilitators in clinical trial training due to variations in scientific disciplines or intervention types. It was noted that the developmental process for drugs and for non-pharmacological behavioral CTs have more similarities than differences. In both, findings from the relevant basic sciences are translated into CTs by development and investigation of treatments and moderators, followed by refinement for adaptation to specific diagnosis or specific population subgroups. During the first phase of CTs, investigators evaluate dosage, safety, adherence, delivery, and fidelity of intervention. The second and third phases assess efficacy and effectiveness, respectively. The NIH Summer Institute on Randomized Behavioral Clinical Trials is a long standing intensive two-week residential program geared towards behavioral randomized clinical trial methodology and intervention research. It aims to increase the number of researchers well versed in clinical trial methodology in order to foster rigorous non-pharmacological clinical trials, particularly with respect to reducing bias in the absence of blinding and maintaining equipoise.

Unique aspects of training in translational and clinical research, particularly for physician-scientists, was also discussed. It is a general assumption that physician investigators obtaining an academic appointment at a medical school will also engage in clinical research. However, the majority of first-time faculty members have not been trained in CTs during medical school and/or residency, even though they may be eager to conduct them. Furthermore, many faculty members do not have protected time for research, particularly early in their academic careers. Therefore, investigators may not be completely aware of the responsibilities the Principal Investigator (PI) role entails when developing their first trial.

Demographic Diversity in Clinical Trials

In this portion of the session, panelists provided perspectives on the barriers and facilitators to training in clinical trials focused on enhancing representation of women and underrepresented racial and ethnic groups as CT leaders.

There are significant differences in gender equality in clinical trials and clinical research as women tend to participate less due to infrequent mentorship and less sponsorship as compared to men. One of the primary reasons is that being listed as first author on publications of trials during training do not necessarily lead to senior authorship and trial leadership for women investigators. The Women As One organization focuses on uniting  women “as one” to broaden and promote the global talent pool in medicine by providing unique professional opportunities to women physicians. The organization has sought to increasewomen participation as clinical trialists by creating a global database of women working in cardiology (“talent directory”).  This directory includes research focused profile fields such as interest in clinical trial leadership experience, clinical trial interest areas, site level research experience, publication & grant writing, and review experience. Data from the talent directory contributes to the identification, development, and dissemination of research training programs and training opportunities.

Research teams should also reflect the populations they are recruiting and should be trained to provide a receptive environment for populations underrepresented in CTs. Health systems serving populations underrepresented in clinical research may have been subject to long-standing disinvestment, and therefore trainees in these environments may lack resources and infrastructure to effectively conduct clinical trials, including staffing, sufficient incentives or resources (e.g., compensation, transportation) to support participant enrollment. Investigators need to develop the necessary skills in cultural competency to ensure potential participants feel comfortable participating in the research. Enhancing diverse participation in clinical trials is important, as many Americans do not benefit from advances in clinical research; people from historically marginalized racial and ethnic groups make up to 40% of the US population but account for less than 20% of research participants. Increasing diversity in clinical trialists may increase participation of women and underrepresented racial/ethnic participants clinical trials.

Building diverse research teams

The final part of this session explored the training and development of diverse research study teams beyond the principal investigator, such as community partners, study coordinators, and program managers. Community engaged research and the engagement of stakeholders can inform all stages of study design and implementation. Investigators should build foundations for community engagement by gaining knowledge of the community, understanding community resources, and seeking to develop strong partnerships and a culture of community engagement. Investigators need to be aware of the breadth of goals for engagement activities, such as: awareness, enrollment, education, motivating change, and empowerment. Equitable partnership with community stakeholders can engage diverse populations by incorporating patient/participant experiences and leveraging community assets and technology. Investigators should learn how to develop recruitment strategies and enrollment plans that leverage data analytics to improve recruitment and retention of populations underrepresented in clinical research. Ultimately, research should be patient/participant-centered and the outcomes should be shared and acted upon immediately upon completion of the study protocols.

The importance of enhancing the pipeline of clinical trialists from populations underrepresented in biomedical research was reiterated as an important strategy for enhancing participant diversity in clinical trials. An analysis of NIH R01 funding trends showed that Black investigators tend to propose research on topics such as community and population level research, which had lower award rates as compared to more mechanistic investigations that have higher award rates (Lauer, et al., 2021). The Programs to Increase Diversity Among Individuals Engaged in Health-Related Research (PRIDE) program (now known as the Programs for Inclusion and Diversity Among Individuals Engaged in Health Related Research) aims to enhance the diversity of the biomedical workforce by developing research skills to mitigate current disparities in research funding. The program has been shown to increase investigators’ number of scientific publications, academic promotions, professional presentations, and grant applications (Boutjdir et al., 2019).

The diversity of skills required to support a clinical research protocol is broad and potentially includes recruiters, protocol navigators, clinical facility staff, clinicians and research nurses, data managers, administrative support staff, laboratory staff, regulatory monitors, and academic and community collaborators. Considerations for selecting research staff include their clinical backgrounds, the type of participant and intervention and how that influences the skills needed to address safety and monitoring during the trial, prior research experience, organizational skills, and soft skills (e.g., organization, flexibility, communication, and adapting to change). A structured onboarding plan is beneficial and should include establishing mentors and/or preceptors; providing professional development through ongoing training and certification; and supporting networking, knowledge sharing, and innovation. Ultimately, this will facilitate integration and retention on the team.

Research-naïve investigators and/or study sites are challenged by the lack of research experience and/or familiarity with regulatory requirements, competing demands of other clinical or academic obligations, and general lack of resources or infrastructure. Training coordinating center staff to provide training and support to these investigators and/or sites (i.e., “train the trainer”) can provide assistance through the processes of getting a study launched. Coordination center staff may have further training needs such as awareness of single-site and multi-site operations and processes, project management skills, and federal or even global regulatory requirements. Finally, staff must understand the research goals and funding source in order to strategize the best way to support sites while conserving overall study funds. In addition, there needs to be staff who specialize in contracting to liaise with legal teams who are establishing the agreements for all of the study sites.

SESSION 3

Clinical Trialist Career Development--Curricula and Training Environment

Panelists

• Lawrence Baizer, PhD, National Center on Sleep Disorders Research, NHLBI (Moderator)
• Hannah Valantine, MD, MRCP, FACC, Stanford University
• Kenneth E. Freedland, PhD, Washington University School of Medicine
• Tracy Y. Wang, MD, MHS, MSc, Patient-Centered Outcomes Research Institute
• William J. Meurer, MD, MS, University of Michigan
• Margaret MacMillan, MD, MSc, FRCPC, University of Minnesota
• Sherry Pagoto, PhD, University of Connecticut
• Mathew W. Semler, MD, MSc, Vanderbilt University Medical Center
• Marie Steiner, MD, MS, University of Minnesota
• Rachel Stanley, MD, MHSA, Professor, The Ohio State University Nationwide Children’s Hospital

Several existing training programs that target early career clinical trialists were reviewed to compare their program goals, target participants, unique and common curricular elements in order to glean best practices, outcomes, and future opportunities. Presentations indicated that modern-day CTs are utilizing new approaches that should incorporated into the training of clinical trialists. This session also explored the role of clinical research networks as unique training environment.

Existing short-term training programs for Clinical Trials Training

Faculty representing five training programs across the spectrum of disciplines and investigator demographics provided brief overviews of their programs:

• American Heart Association’s Strategically Focused Research Network (SFRN) on the Science of Diversity in Clinical Trials-Train Researchers to Advance Inclusion Networks (TRAIN)
• NIH OBSSR Summer Institute on Randomized Behavioral Clinical Trials
• American College of Cardiology Clinical Trials Research: Upping Your Game Program
• National Institute of Neurological Disorders and Stroke Clinical Trials Methodology Course (CTMC)
• American Society for Transplantation and Cellular Therapy (ASTCT) Clinical Research Training Course (CRTC)

Notable features of the programs included:

• Hybrid designs, with a mix of in-person interactions and synchronous virtual interactions, with careful attention to the selection of topics for each mode
• A blend of didactics, small group discussions, and one-on-one mentoring
• Didactics on basic principles of clinical research design such as biostatistics, study design, and bioethics, regulatory issues, operational issues (e.g., recruiting and training study staff, developing a study budget, and writing a study protocol), data management, statistics, grant writing, and mentorship
• Policies and best practices for enhancing diversity in clinical trials
• Fundamentals of community engaged research
• Mentorship by program faculty which compliments mentorship from home institution and may occur longitudinally over the course of a year after program initiation
• Specific methodologies such as multi-phase optimization strategy (MOST) and other adaptive trial designs, mHealth methodology, and pragmatic trials
• Developing research funding proposals and receiving feedback from course faculty, including a biostatistician, and peers

Enhancing Training in Modern-Day Methodologies

There is increasing emphasis on the need for trials to be cost-effective with significant clinical and/or public health impact while also optimizing participant inclusion, recruitment, and retention. Mobile health/remote technology, use of electronic health records, and novel trial designs have gained interest as a response to this challenge, but may increase the complexity of conducting CTs. This portion or the session explored the challenges and opportunities for enhancing training in emerging CT methodologies.

Digital Technology

Technology has innovated each stage of CT research. The use of technology is a fast-evolving ecosystem and is drastically changing how clinical trials are carried out. It provides an opportunity to perform 100% remote trials, with the potential for nationwide recruitment. Technology is used in different segments of CTs such as:

• Recruitment using electronic health records (EHR), social media, online sources, training CT recruitment companies and remote consenting of trial participants
• Data collection using EHR, mobile apps, ecological momentary assessment (EMA), wearables, and other devices
• Intervention delivery using mobile apps, web platform, social media, variables
• Dissemination of results using social media or data repositories

Challenges associated with technology in clinical trials include limited exposure of early career investigators during their training. In addition, senior researchers often are not trained in the use of digital technology for CTs; therefore, there are few mid-career or senior mentors with this expertise. Additional challenges include complicated data management and analysis due to the volume of data and the type of data sources, and the possibility of novel ethical issues associated with use of technology that novice investigators may be naïve to. The skills needed to leverage technology and clinical trials training are becoming increasingly transdisciplinary, including human centered design, user experience, health informatics, bringing technology to market, and innovating telehealth to enhance the video visit experience. Additionally, expertise in data science may be necessary for analysis of longitudinal data, and other possible training includes network science, machine learning, cost effectiveness, and behavioral interventions.

There is a need for opportunities to expand fellowship training in data science through either career development awards or research center grants that can provide support for investigators to learn to use technology in clinical trials. Other opportunities include:

• Internships in health technology companies to understand the commercial aspect
• Guidance for integrating health technology education and clinical and public health graduate training programs
• Team science in initiatives that facilitate collaborations across the clinical and STEM fields
• Funding opportunities to test technology driven approaches for accelerating clinical trial recruitment
• Technology driven recruitment innovation scaled up to serve more trialists

Pragmatic/Adaptive Trials

Explanatory trials determine the mechanistic effects of an intervention under idealized conditions, as they have numerous exclusion criteria, resulting in a narrow trial population. These trials occur in research settings where the interventions are delivered by research personnel, may have mechanistic outcomes and are well suited to the evaluation of new drugs or devices. The data generated by these trials is collected by study personnel. The disadvantage of explanatory trials is that they are costly and time consuming. In contrast, pragmatic trials seek to evaluate the effectiveness of treatments in clinical care. Pragmatic trials typically have simple eligibility criteria with few exclusions in a clinical care setting where the interventions are delivered by the clinicians who routinely provide care at the site. Data generated by pragmatic trials are reported through EHR and frequently include patient-centered outcomes; therefore, these trials are well suited to evaluating broadly available therapies, often in current use and are more efficient. They help in identifying available treatment options that improve care and outcomes of critical illness. Pragmatic trials are a relatively new methodology but have already generated much of the evidence for developing clinical critical care guidelines and practice. The pragmatic approach helps to avoid some of the cost, risks, and inefficiencies that make clinical trials challenging to support.

This is the first generation of pragmatic trialists, and their experiences have informed the steps necessary for learning how to perform pragmatic trials:

• Gain an intimate understanding of the clinical setting; a clinician should work in the environment where the research will occur
• Receive mentorship from experienced trialists; with an emphasis on methodologic expertise over subject matter expertise
• Design and conduct randomized trials; taking original ideas from conception to completion is where the learning is concentrated
• Complete coursework relevant to randomized trials (e.g., statistics, informatics, study design but rarely specific to pragmatic RCT); this often leads to an additional degree for clinicians (i.e., MSCI, MSCR, MPH, or PhD)
• Seek or create environment that values innovation, efficiency, and impact; a supportive institutional culture is of the utmost importance

The NIH Pragmatic Trials Collaboratory is a community that is a key resource for NHLBI- funded trialists. Additionally, a dedicated training program for pragmatic trials could emulate previous successful NHLBI-supported career development K12 award programs for acute care, implementation science, and HIV. Pragmatic trial mentors are limited in number and are overcommitted; therefore, the existing Mid-career Investigator Award in Patient Oriented Research (K24) could be a way to support a pragmatic trial mentor in developing multiple mentees. Future CT networks could incorporate an explicit aim to train early career investigators as a byproduct of conducting trials.

Role of Research Networks in Clinical Trialist Training: Mentoring and Experiential Learning

Early career investigators need repeated exposure to clinical trials for effective training. Large multi-site CT, as opposed to single-site trials, have a richness and depth of the issues that make them particularly well suited to incorporate a training component to foster training of clinical trialists. Maturation of a clinical trialist occurs by taking advantage of opportunities in the research networks through a natural progression of steps that foster enhanced knowledge and independence: 1) exposure and observation, 2) participation and networking, 3) contribution and collaboration, and 4) mentored and independent leadership roles. Trainees or junior faculty can begin by observing and participating in all study related meetings. This should progress to participating in discrete study tasks such as chart abstraction and then graduating to more complex study tasks such as participant screening and enrollment. Early career investigators should be encouraged to participate in clinical trial-related committees and present nascent ideas; these research networks can be “protected” environments for learning. Additionally these networks may provide support from mentors who are proactive, available, and committed. Mentors should support and sponsor early career investigators by directing them to opportunities for participating on writing groups, grant proposals, and other training opportunities.

Pediatric Emergency Care Applied Research Network (PECARN) is a multi-institutional network for research in pediatric emergency medicine in the United States and serves as an example of a research network with strong programming and support for early career investigators. PECARN conducts an early investigator program, held annually in conjunction with one of the regular network meetings, where early career investigators from each of the participating network sites are invited to attend and present their research to potential mentors from across the network and any NIH program officers in attendance. They also participate in small groups to discuss career development concerns such as mentoring and grant funding.

Aligning career progression with the progression of the science is a major concern for the transition of early career investigators to become independent clinical trialists. Engaging junior investigators in multi-disciplinary and established larger networks early in their career is an important strategy for mitigating this challenge. Key opportunities to enhance the training experience within clinical research networks include:

• Supporting junior investigators with diversity supplements and grants for ancillary studies which may help increase their engagement in the design and analysis of trials
• Establishing a mentoring relationship by pairing a senior investigator with junior investigator to help with various aspects of the study such as developing the study protocol
• Providing travel support to interact with peers and mentors across the network and attend professional development activities such as courses and conferences
• Providing adequate protected time for mentors to effectively mentor and recognition of their efforts by their institutions in promotion and tenure considerations
• Recognizing efforts of early career investigators as site investigators and “middle” authorship as valuable academic productivity for promotion and tenure
• Expanding the breadth and diversity of trialists, with a focus on international investigators
• Cross-linking of individual research programs into larger multi-center networks takes longer to implement but could help with advancing research by addressing recruitment issues, database issues, and other challenges and also supports the collaboration across institutions, disciplines, and career stages
• Mentorship is a dynamic process, and the balance between remote mentoring and the more intensive in-person programs is important
  • Every trainee needs a committee of mentors where each mentor serves different purposes in clinical research training
  • It is possible to have mentors far away from the local sites within the network; however annual network meetings enable the junior investigators to meet with their mentors yearly

SESSION 4

Breakout Sessions

Attendees split into small groups to reflect on the prior speakers and discussions and identify opportunities and challenges to clinical trialist career development.

What are the most important “core competencies” (e.g., knowledge, skills, experiences) needed for HLBS Clinical Trialists to conduct high-impact clinical trials?

There is a need to obtain the right balance between core skills that are universal across all trials and specialized skills specific to the study topic, participant characteristics, and intervention type. Additionally, these core and specialized competencies should be gained through the right balance of didactic components and experiential learning. Topics applicable to all clinical trialists include:

• Training on operational issues such as budgeting, identification of staffing needs, and recruitment and retention  of study staff
• Training on community engagement approaches with a focus on diversity, equity, and justice and how it can inform the selection of the study question and all aspects of study design including recruitment, data analysis, implementation and dissemination
• A basic understanding of and exposure to FDA regulatory approval procedures; this is important for understanding the study design issues that could impact regulatory approval and subsequent widespread dissemination and implementation

What are the most significant challenges to learning how to design and implement HLBS focused clinical trials?

• Time management is an important issue and significant challenge. Obtaining assurance of protected time is the most challenging for early career researchers. Early-stage investigators often have competing demands such as clinical and/or teaching responsibilities; particularly for clinicians, their ability to generate clinical revenue may be more highly valued from an institutional standpoint.  Mentors have a critical role in helping the junior investigator learn to be efficient in managing competing demands.
• Providing protected time for mentors to support their trainees in submitting funding applications and starting the study is challenging. The Midcareer Investigator Award in Patient-Oriented Research (K24) is an important mechanism for providing mentor support that could promoted.
• The distribution of trial resources is uneven and may not be available to all of the trainees who need it; some junior investigators are great scientists but are geographically or institutionally remote from research infrastructure. A visiting professorship for mentor trialists may be a strategy to bring clinical trial expertise to an institution.

How can aspects of the training environment be improved to support the career development of HLBS clinical trialists?

There are many opportunities to expose early career investigators to important aspects of trial development:

• Developing a study that addresses an important question. This will often involve collaboration with a laboratory scientist who has an observation that can translate to clinical research and determine feasibility of the trial.
• Protocol development. Early career investigators can be involved with protocol writing to learn how to ensure patient protection and inclusion of groups that may benefit from the study. This requires strong collaboration with the statistician to help define the goals, endpoints, safety, and analysis plan.
• Securing funding and regulatory approvals. Early career investigators can be involved in writing and submitting applications to funding and regulatory agencies.
• Establishing operational infrastructure for site activation, enrollment, and ongoing study monitoring.  This entails the hiring and training of regulatory staff to help obtain all of the necessary approvals, biostatisticians, research coordinators to ensure proper entry and analysis of datasets, laboratory staff for correlative studies, and data management and database support.
• Mentorship with senior investigators is helpful and hence, taking steps to construct such a relationship is important.
• Junior investigators need to be in leadership roles as delegation and follow-up skills are important; learning how to communicate in a timely and accurate manner and knowing when to seek help as needed all contribute to ensuring that the study progresses in a timely fashion.
• A “train the trainer” approach for study can help enhance research capacity, particularly for multi-site trials.

What are the challenges to and opportunities for enhancing the diversity (e.g., discipline, gender, race/ethnicity, geography, etc.) of HLBS clinical trialists throughout the pipeline?

• Recruitment of more diverse patient populations is important, but often difficult, for clinical trials. Implementation science has focused on community engagement to increase enrollment; however, community engagement has a role in all stages of clinical research.
• Changing institutions, as is common for early career researchers in academic careers, can pose a major challenge to developing and maintaining their relationships with community members.

Disclaimer: The findings, knowledge gaps, and opportunities described here represent a summary of individual opinions and ideas expressed during the workshop. The summary does not represent a consensus opinion or directive made to or by NHLBI or NIH.

Workshop Co-Chairs

Daniel J. Buysse, MD
Distinguished Professor of Psychiatry, Medicine, and Clinical and Translational Science
UPMC Endowed Chair in Sleep Medicine
University of Pittsburgh
Hannah Valantine, MD, MRCP, FACC
Professor of Medicine (Cardiovascular), Stanford University
Former NIH Chief Scientific Officer for Scientific Workforce Diversity

NHLBI Staff Contact

Nicole Redmond, MD, PhD, MPH
Chief, Clinical Applications and Prevention Branch
Division of Cardiovascular Sciences, NHLBI

NHLBI Workshop Organizing Committee

Lawrence Baizer, PhD, National Center on Sleep Disorders Research
Marishka K. Brown, PhD, National Center on Sleep Disorders Research
Rebecca Campo, PhD, Division of Cardiovascular Sciences
Fungai Chanetsa, PhD, MPH, Division of Extramural Activities
Keary Cope, PhD, MPH, Division of Extramural Activities
Nancy DiFronzo, PhD, Division of Blood Diseases and Resources
Laurie Donze, PhD, Division of Cardiovascular Sciences
Lawrence Fine, MD, DrPH, Division of Cardiovascular Sciences 
Michelle Freemer, MD, MPH, Division of Lung Diseases
Roya Kalantari, PhD, Division of Lung Diseases
Gail Pearson, MD, ScD, Division of Cardiovascular Sciences
Nicole Redmond, MD, PhD, MPH, Division of Cardiovascular Sciences
Yves Rosenberg, MD, MPH, Division of Cardiovascular Sciences
David Schopfer, MD, Division of Cardiovascular Sciences
Jane Scott, ScD, MSN, Division of Cardiovascular Sciences
Veronica Tutse-Tonwe, MSHS, Center for Translation Research and Implementation Science
Debbie Vitalis, PhD, Division of Cardiovascular Sciences
Wayne Wang, PhD, Division of Cardiovascular Sciences
Makeda Williams, PhD, MPH, Center for Translation Research and Implementation Science

Related NHLBI Resources

Training and Career Development
Clinical Trial Development Continuum
Optimizing NHLBI's Clinical Trials Enterprise

NHLBI-supported Research Networks

ARDS Clinical Trial Network (ARDSNet)
AsthmaNet
Blood and Marrow Transplant Clinical Trials Network (BMT CTN)
Cardiothoracic Surgical Trials Network (CTSN)
Heart Failure Clinical Research Network (HFN)
Pulmonary Trials Cooperative