The Duke Research Equity and Diversity Initiative (READI) was established in 2021 to engage Durham and surrounding communities in clinical research and build capacity to promote equitable access to research participation. Within READI, a voucher program was launched with the goals of increasing diverse participation in clinical research, improving community-partnered research, and enhancing community engagement. The vouchers leveraged a stand-alone, community-centered, outpatient research clinic, the Duke Research at Pickett (R@P) facility, which was originally opened to support COVID-19 trials. A formative evaluation of the voucher program was conducted with 3 voucher-awarded teams, READI personnel, and R@P staff. Data included 18 semi-structured interviews (n = 14) over two timepoints (Spring 2023, 2024). A rapid response analysis approach was used. Data indicate that READI voucher-awarded services were useful for voucher teams, with value for supporting community-engaged efforts, making research participation accessible, creating a community-centered and streamlined service facility, and personnel development benefits. Communication and flexibility of support services facilitated program implementation. Challenges occurred in service utilization logistics and incorporating community engagement into research support services. Ultimately, we find that a research support program with embedded community engagement support is feasible; this type of support can be integral in normalizing community-engaged research.

A clinical research team’s goal is to support the implementation, conduct, and monitoring of research studies and corresponding protocols. There is a need to ensure that study teams have adequate resources and regulatory support to successfully adhere to regulations and good clinical research practices. Our team, the UC Davis Division of Infectious Diseases Research Unit (IDRU), sought to establish a One Signature Initiative program for all studies and protocols supported by the IDRU. The One Signature Initiative designates one point of contact from each ancillary team or department to sign delegation and training logs, who in turn is delegated to train their team. The goals of the One Signature Initiative were, and are still, to reduce task redundancy, lessen regulatory burden on research teams, and minimize audit findings. Since the implementation of the One Signature Initiative in 2023, acceptance has been favorable, and we have expanded its footprint by incorporating it into our standard operating procedures. This article discusses our experiences, and ancillary departments’ experiences, with the One Signature Initiative. Our experience is an example of how a One Signature Initiative can be developed that is efficient, effective, and well-accepted by clinical research stakeholders.

Despite the availability of vaccinations, severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) continues to cause Coronavirus Disease 2019 (COVID-19) infection with a spectrum of disease in the acute setting. Transmission, infection, and severe disease remain common. There is a critical need to establish treatment regimens in the ambulatory setting that can reduce symptom burden and potentially prevent progression to severe disease and death. Many existing medicines previously approved for other uses may have benefit but remain unproven in informative clinical trials.

Accelerating COVID-19 Therapeutic Interventions and Vaccines (ACTIV)-6 is a decentralized, placebo-controlled, double-blind, randomized, platform trial that has now enrolled more than 7500 participants and has reported on the effectiveness of ivermectin at two doses, fluticasone, and fluvoxamine for helping people with COVID-19. With additional repurposed therapies added to the platform, ACTIV-6 continues to enroll symptomatic outpatients aged ≥ 30 years with a confirmed positive PCR or antigen test for SARS-CoV-2. Potential participants are screened and enrolled online, through a call center, or facilitated by local study sites. Participants consent electronically and are randomized to placebo or to one of the open study drugs for which they are eligible at the time of enrollment. A shared, contemporary placebo approach is used. Participants receive study drug in the mail and remain on study for up to 180 days. While enrolled, electronic patient-reported outcome assessments are used to monitor symptoms, healthcare utilization, and mortality. The primary endpoint is time to recovery or a composite of hospitalization and mortality within 28 days. Symptoms, acute healthcare utilization, and the Patient-Reported Outcomes Measurement Information System-29 are collected for up to 180 days.

Using a decentralized trial approach allowed the ACTIV-6 platform to increase both reach and rate of enrollment. The decentralized approach did not simplify regulatory oversight, and we found unanticipated challenges in patient behavior and the study drug delivery process. Despite challenges, ACTIV-6 has enrolled thousands of participants from across the USA and continues to test the effectiveness of repurposed medicines for treating COVID-19. Our lessons learned contribute to the emerging understanding of how to optimize decentralized trials.

There has been an erosion of trust in medical care and clinical research, and this has raised issues about whether institutions and investigators conducting clinical research are worthy of trust. We review recent literature on research on trust and trustworthiness in the clinical research enterprise and identify opportunities to enhance trustworthiness, which will likely increase participant trust in clinical research. In addition, we review materials reporting the results of national polls related to the public’s trust in different occupations. The literature on trustworthiness and trust is complex and suffers from a lack of agreement on definitions of trust and trustworthiness and actions to enhance trustworthiness. Nonetheless, institutions need to take action to address the many elements that contribute to being perceived as trustworthy. As a complementary approach, since nurses have consistently ranked highest on trust by the public for twenty-two straight years, we analyze the features that likely account for the public’s uniform high regard for nurses. We propose specific actions to enhance the role of research nurses in the research enterprise, without compromising their primary role as participant advocates, that we have adopted at Rockefeller University to gain the benefits of the public’s trust in nurses in building trustworthiness.

While community engagement (CE) has been increasing in the mental and behavioral health fields, evaluation of CE remains a challenge. Currently, there are no published evaluation tools that assess frequency of engagement, and many CE measures are not based on established engagement theories. Based on the International Association for Public Participation’s CE continuum, the CE team of the Mental and Behavioral Health Institute (MBHI) at a large pediatric hospital developed a system of measurement to describe frequency of engagement across eight initiatives. This tool, the Frequency of Active Community Engagement (FACE) measure, was administered to the leaders of each of the participating MBHI teams. FACE summarized CE frequencies for three target populations (youth, caregivers, and community members) for each team. Follow-up team meetings provided additional descriptive information for the development of CE goals. In this special communication, we describe this data collection approach, CE results, as well as future directions and potential uses for FACE as an evaluation tool.

Involving participants in the design of clinical trials should improve the overall success of a study. For this to occur, streamlined mechanisms are needed to connect the populations potentially impacted by a given study or health topic with research teams in order to inform trial design in a meaningful and timely manner. To address this need, we developed an innovative mechanism called the “ResearchMatch Expert Advice Tool” that quickly obtains volunteer perspectives from populations with specific health conditions or lived experiences using the national recruitment registry, ResearchMatch. This tool does not ask volunteers to participate in the trial but allows for wider community feedback to be gathered and translated into actionable recommendations used to inform the study’s design. We describe early use cases that shaped the current Expert Advice Tool workflow, how results from this tool were incorporated and implemented by studies, and feedback from volunteers and study teams regarding the tool’s usefulness. Additionally, we present a set of lessons learned during the development of the Expert Advice Tool that can be used by other recruitment registries seeking to obtain volunteer feedback on study design and operations.

Reference standards are vital for harmonizing heterogeneous clinical data for research, but little is known about their implementations or costs. We surveyed NIH Clinical and Translational Science Awards (CTSA) hubs to assess operational dimensions of institutional implementation, maintenance, and use of the Logical Observation Identifiers, Names, and Codes (LOINC) standard. Respondents (n = 19,30%) exhibited substantial variability in approaches to implementation. Differences in number and training of staff and frequency of mapping updates make it difficult to estimate costs and comparability of data across sites. CTSA and other multi-site research can benefit from operational definitions and recommended processes for LOINC implementation.

Clinical research studies run the risk of being in a deficit leading to premature study termination or a desperate struggle to find new funding to continue the research. It is important for institutions, small or large, to have financial oversight during the research process. We created a financial audit process for a core clinical research department at a pediatric hospital. Understanding where to find your costs, what costs are important, and other elements of the audit process are essential. Knowing how to replicate a financial audit process can help you eliminate the risk of a financial deficit.

Although highly involved in heart failure (HF) patients’ care, home care workers (HCWs) lack HF training and are poorly integrated into the healthcare team. For its potential to address these challenges, we examined the role of technology among HCWs caring for HF patients. We conducted 38 interviews with key stakeholders. Overall, four themes emerged. Participants reported that technology is critical for HF care, but existing systems are outdated and ineffective. HCWs also have limited access to electronic resources. Technology, training, and principles of implementation science can be leveraged to improve HCWs’ experience in caring for HF patients and home healthcare delivery.

Academic health sciences libraries (“libraries”) offer services that span the entire research lifecycle, positioning them as natural partners in advancing clinical and translational science. Many libraries enjoy active and productive collaborations with Clinical and Translational Science Award (CTSA) Program hubs and other translational initiatives like the IDeA Clinical & Translational Research Network. This article explores areas of potential partnership between libraries and Translational Science Hubs (TSH), highlighting areas where libraries can support the CTSA Program’s five functional areas outlined in the Notice of Funding Opportunity. It serves as a primer for TSH and libraries to explore potential collaborations, demonstrating how libraries can connect researchers to services and resources that support the information needs of TSH.

The National Institutes of Health All of Us Research Program (All of Us or program) aims to better understand the complexity of diseases, prevention and treatment at the individual level. To accomplish this, one of the program components is to build a longitudinal cohort of one million or more volunteers in the United States and its territories through which clinical, environmental, genetic, and behavioral data are collected. Federally Qualified Health Centers (FQHCs) play a crucial role in enrolling participants in the program and while FQHCs have the dedication, leadership, and wherewithal to operationalize a national longitudinal data collection, their local resources are limited by funding and scope for conducting research. This paper describes the evolution of FQHC research landscape, from building capacity for descriptive, to exploratory operational research, and moving toward biomedical research. As programs such as All of Us continue to ensure that focus on precision medicine is reflected in both data collection and research, continuing to advance the research landscape within health centers is crucial. By developing this capacity, we are developing a research infrastructure that will continue to grow, supporting advancements in precision medicine for improving health outcomes.

The ACT Network was funded by NIH to provide investigators from across the Clinical and Translational Science Award (CTSA) Consortium the ability to directly query national federated electronic health record (EHR) data for cohort discovery and feasibility assessment of multi-site studies. NIH refunded the program for expanded research application to become “Evolve to Next-Gen ACT” (ENACT). In parallel, the US Food and Drug Administration has been evaluating the use of real-world data (RWD), including EHR data, as sources of real-world evidence (RWE) for its regulatory decisions involving drug and biological products. Using insights from implementation science, six lessons learned from ACT for developing and sustaining RWD/RWE infrastructures and networks across the CTSA Consortium are presented in order to inform ENACT’s development from the outset. Lessons include intentional institutional relationship management, end-user engagement, beta-testing, and customer-driven adaptation. The ENACT team is also conducting customer discovery interviews with CTSA hub and investigators using Innovation-Corps@NCATS (I-Corps™) methodology for biomedical entrepreneurs to uncover unmet RWD needs. Possible ENACT value proposition hypotheses are presented by stage of research. Developing evidence about methods for sustaining academically derived data infrastructures and support can advance the science of translation and support our nation’s RWD/RWE research capacity.

This study investigates practicing clinician and staff perspectives on potential protocol modifications for the “Nasal Irrigation, Oral Antibiotics, and Subgroup Targeting for Effective Management of Acute Sinusitis” (NOSES) study, a pragmatic randomized controlled trial aiming at improving acute rhinosinusitis management. Focus groups with clinicians and staff at the pretrial stage recommended expanding participant age inclusion criteria, incorporating patients with COVID-19, and shortening the supportive care phase. Participants also discussed patient engagement and recruitment strategies. These practical insights contribute to optimizing the NOSES trial design and underscore the value of qualitative inquiries and healthcare stakeholder engagement in informing clinical trial design.

The obesity epidemic has continued to rise at an alarming rate and has increased health complications in children, adolescents, and adults. Resistance training, aerobic training, and a combination of the two have been shown to be effective at reducing excess adiposity and improving outcomes of obesity. The continued development of programs, community centers, or medical exercise facilities prescribing these treatments is nearing an absolute necessity to slow the advancing nature of obesity and related metabolic diseases. In this brief review, we summarize the effectiveness of these three training paradigms from a population-centric perspective.