Researchers and policymakers recognize that leveraging data routinely collected in clinical practice can support improved research and patient care. Embedding elements of clinical trials, such as patient identification and trial data acquisition, into clinical practice can enable research access and increase efficiencies by reducing duplication of trial and care activities. Yet, cultural, administrative, and data barriers exist. The Clinical Trials Transformation Initiative (CTTI) developed evidenced-based, multi-partner recommendations to facilitate embedding interventional, randomized trials into clinical practice.

We conducted in-depth interviews (IDIs) with trial designers and implementers to describe their motivations for embedding interventional, randomized trials into clinical practice. Additionally, we aimed to identify barriers and potential solutions to implementing such trials. Interviews were audio-recorded and analyzed using applied thematic analysis.

We conducted 16 IDIs with 18 trial designers and implementers. Motivations for embedding trials into clinical practice included the desire to implement a learning health system and evaluate trials in real-world settings. Barriers to trial implementation focused on limited staff time and availability, the lack of buy-in, and difficulties using electronic health record data. Solutions included minimizing healthcare settings and patient burden, having a sufficient data and research infrastructure in place, and creating a culture change.

The results informed CTTI recommendations to facilitate the design and operation of embedded trials. These recommendations emphasize areas where sponsors and investigators can rethink the design and conduct of clinical trials to ultimately realize an aligned system of research and care.

Researchers and research organizations acknowledge the importance of paying research participants but often overlook the process of providing participant payments as a locus for improving equity and inclusion in clinical research. In this conceptual paper, we argue that participants’ lived experiences and social context should be recognized and respected when developing these processes.

We consider how participant payment processes that require specific payment types, delay the timing of payment, or require sharing sensitive information may impose barriers to equitable research. Building on findings from empirical research of participants’ perspectives on respect in research and a relational ethics framework of person-oriented research ethics, we explore how researchers and research organizations can better demonstrate respect through the research participation payment process.

We propose five considerations for demonstrating respect when providing payment: (1) practice cultural humility, (2) be mindful of socioeconomic factors, (3) be flexible, (4) be transparent, and (5) maintain open communication. These considerations are intended to address the lack of existing ethical guidance around the process for participant payments and promote more inclusive clinical research. We provide a set of sample questions for research teams to consider how they could modify their payment processes to better demonstrate respect.

By better demonstrating respect for participants when providing payment, researchers can work toward ensuring that their research procedures are more inclusive, respond to the needs of diverse communities, and result in more equitable relationships with participants.

Integrating community expertise into scientific teams and research endeavors can holistically address complex health challenges and grand societal problems. An in-depth understanding of the integration of team science and community engagement principles is needed. The purpose of this scoping review was to identify how and where team science and community engagement approaches are being used simultaneously in research.

We followed Levac’s enhancement of Arksey and O’Malley’s Scoping Review Framework and systematically searched PubMed, CINAHL, Scopus, ERIC, and Embase for team science and community engagement terms through January 2024.

Sixty-seven articles were reviewed. Publications describing integrated team science and community-engaged research have increased exponentially since 2004. Over half were conducted outside of the U.S., utilized qualitative methods, included community-researcher co-development of research question and study design, and described team partnership goals, roles, and management. Fewer studies evaluated partnership, built community capacity, described financial compensation to communities, or described team dynamics facilitation.

As researchers continue to integrate community engagement and team science, common criteria and strategies for integrating the approaches are needed. We provide 19 recommendations for research teams, research institutions, journals, and funding bodies in service of advancing the science and practice of this integration.

In Michigan, the COVID-19 pandemic severely impacted Black and Latinx communities. These communities experienced higher rates of exposure, hospitalizations, and deaths compared to Whites. We examine the impact of the pandemic and reasons for the higher burden on communities of color from the perspectives of Black and Latinx community members across four Michigan counties and discuss recommendations to better prepare for future public health emergencies.

Using a community-based participatory research approach, we conducted semi-structured interviews (n = 40) with Black and Latinx individuals across the four counties. Interviews focused on knowledge related to the pandemic, the impact of the pandemic on their lives, sources of information, attitudes toward vaccination and participation in vaccine trials, and perspectives on the pandemic’s higher impact on communities of color.

Participants reported overwhelming effects of the pandemic in terms of worsened physical and mental health, financial difficulties, and lifestyle changes. They also reported some unexpected positive effects. They expressed awareness of the disproportionate burden among Black and Latinx populations and attributed this to a wide range of disparities in Social Determinants of Health. These included racism and systemic inequities, lack of access to information and language support, cultural practices, medical mistrust, and varied individual responses to the pandemic.

Examining perspectives and experiences of those most impacted by the pandemic is essential for preparing for and effectively responding to public health emergencies in the future. Public health messaging and crisis response strategies must acknowledge the concerns and cultural needs of underrepresented populations.

There is increasing pressure on the federal research budget and shifting public opinions about the value of the academic enterprise. We must develop and apply metrics that demonstrate the broad benefits of research for health and society. The Translational Science Benefits Model (TSBM) measures the impact of large-scale translational science initiatives, such as the National Cancer Institute’s Cancer Moonshot. TSBM provides the scaffolding to illustrate how science has real-world health impacts. We propose an expansion of the TSBM to explicitly include implementation-focused outcomes.

TSBM includes four categories of benefits, including (1) clinical and medical, (2) community and public health, (3) economic, and (4) policy and legislative. Implementation science outcomes serve as a precursor to the model’s established domains of impact and can help to sharpen focus on the translational steps needed to achieve a broad range of impacts. We provide several examples of studies that illustrate these implementation outcomes and other clinical and community benefits.

It is important to consider a broad range of scientific impacts and the conditions that are necessary to achieve them. The expansion of the TSBM to include implementation science outcomes may help to accelerate the cancer community’s ability to achieve the goal of preventing 4 million cancer deaths by 2047.

Cognitive decline is intricately linked to various factors such as obesity, stress, poor sleep, and circadian rhythm misalignment, which are interrelated in their impact on cognitive health. Irregular food-intake timing further compounds these issues. The practice of prolonged nightly fasting (PNF) may help synchronize food intake with circadian rhythms, potentially mitigating adverse effects of cognitive decline and associated factors.

A pilot nationwide, remotely delivered, 2-arm randomized controlled trial was conducted to assess the 8-week outcomes of cognition, stress, and sleep, after a PNF intervention (14-hr nightly fast, 6 nights/week, no calories after 8 pm) compared to a health education (HED) control condition. Participants were living with memory decline, stress, and obesity and had weekly check-in calls to report fasting times (PNF) or content feedback (HED).

Participants were enrolled from 37 states in the US; N = 58, 86% women, 71% white, 93% non-Latinx, mean (SD) age 50.1 (5.1) years and BMI 35.6 (3.6) kg/m2. No group differences existed at baseline. Linear mixed-effects models were used to compare outcome change differences between groups. Compared to the HED control, the PNF intervention was associated with improved sleep quality (B = −2.52; SE = 0.90; 95% CI −4.30–−0.74; p = 0.006). Perceived stress and everyday cognition significantly changed over time (p < 0.02), without significant difference by group.

Changing food intake timing to exclude nighttime eating and promote a fasting period may help individuals living with obesity, memory decline, and stress to improve their sleep. Improved sleep quality may lead to additional health benefits.

Black and Latino individuals are underrepresented in COVID-19 treatment and vaccine clinical trials, calling for an examination of factors that may predict willingness to participate in trials.

We administered the Common Survey 2.0 developed by the Community Engagement Alliance (CEAL) Against COVID-19 Disparities to 600 Black and Latino adults in Baltimore City, Prince George’s County, Maryland, Montgomery County, Maryland, and Washington, DC, between October and December 2021. We examined the relationship between awareness of clinical trials, social determinants of health challenges, trust in COVID-19 clinical trial information sources, and willingness to participate in COVID-19 treatment and vaccine trials using multinomial regression analysis.

Approximately half of Black and Latino respondents were unwilling to participate in COVID-19 treatment or vaccine clinical trials. Results showed that increased trust in COVID-19 clinical trial information sources and trial awareness were associated with greater willingness to participate in COVID-19 treatment and vaccine trials among Black and Latino individuals. For Latino respondents, having recently experienced more challenges related to social determinants of health was associated with a decreased likelihood of willingness to participate in COVID-19 vaccine trials.

The willingness of Black and Latino adults to participate in COVID-19 treatment and vaccine clinical trials is influenced by trial awareness and trust in trial information sources. Ensuring the inclusion of these communities in clinical trials will require approaches that build greater awareness and trust.

The 2018 Common Rule revision intended to improve informed consent by recommending a concise key information (KI) section, yet provided little guidance about how to describe KI. We developed innovative, visual KI templates with attention to health literacy and visual design principles. We explored end users’ attitudes, beliefs, and institutional policies that could affect implementing visual KI pages.

From October 2023 to April 2024, we conducted semi-structured interviews with principal investigators, research staff, and Institutional Review Board (IRB) personnel, including those in oversight/management, and community partners. Forty participants from three academic institutions (in the Midwest, Southeast, and Mountain West) viewed example KI pages and completed interviews. We coded written transcripts inductively and deductively based on the capability, opportunity, and motivation to change behavior (COM-B) framework. Data were analyzed using content analysis and organized thematically.

Participants responded positively to the visual KI examples. They discussed potential benefits, including improving information processing and understanding of study procedures, diversity in research, trust in research, and study workflow. They also described potential challenges to consider before widespread implementation: IRBs’ interpretations of federal guidelines, possible impacts on IRB submission processes, the effort/skill required to develop visuals, and difficulty succinctly communicating study risks. There was no consensus about when to use visual KI during consent, and some wondered if they were feasible for all study types.

Visual KI offers a promising solution to long-standing informed consent challenges. Future work can explore resources and training to address challenges and promote widespread use.

The stakeholder analysis approach has historically been top-down rather than collaborative with key partners. However, this approach poses challenges for key partner engagement and community-engaged research, which aims to incorporate key partners throughout the project. This study, conducted by the Community Engagement Network at a Midwest Academic Medical Center, seeks to examine the value of community-engaged research for diverse key partners to increase collaboration, strengthen partnerships, and enhance impact, ultimately driving key partner engagement.

The study involved semi-structured interviews with 38 key partners from diverse groups, including community members, community organizations, Practice-Based Research Network members, researchers, research administration, university administration, and potential funders. The interview guide, informed by an extensive literature review, assessed perceived value, barriers, and improvement strategies for community-engaged research, supplemented by value proposition statements.

The analysis revealed three main themes: 1) Fostering Community Buy-In: Authentic representation and inclusive partnerships were essential for trust and commitment; 2) Enhancing Communication and Dissemination: Effective communication strategies were vital for maintaining engagement and sharing research outcomes; and 3) Building Capacity and Ensuring Sustainability: Continuous learning and long-term investments were crucial for sustaining community-engaged research efforts.

This study underscores the value of incorporating key partners into stakeholder analyses to enhance collaboration, strengthen partnerships, and improve the impact of community-engaged research. The findings offer valuable insight for institutional transformation and implementation of effective stakeholder analyses and engagement tools, ultimately enhancing the effectiveness of research strategies and initiatives.

Patient and stakeholder involvement enhances the conduct and applicability of comparative effectiveness research (CER). However, examples of engagement practices for CER leveraging real-world data (i.e., data from routine clinical practice) are scarce. Notably, these studies differ from traditional clinical trials in their technical complexity and minimal prospective data collection, posing unique challenges for stakeholder involvement. This paper describes patient and stakeholder engagement in a CER study of type 2 diabetes (T2D) medications using real-world data from a large administrative claims database.

A Patient and Stakeholder Advisory Group (PSAG) was formed to guide study design, conduct, and dissemination. The PSAG (n = 12) included individuals with T2D, clinicians, health systems leaders, professional society representatives, and a payer representative. Members were surveyed post-study initiation to assess their participation goals and experiences to date.

PSAG members influenced key design and methodological decisions, including cohort selection and adding an aim focused on patient preference elicitation. Survey results indicated high satisfaction with engagement processes and a desire for ongoing involvement. Most PSAG members cited their main goals as impacting the lives of people with T2D and ensuring the research’s relevance to clinicians.

Best practices for engaging stakeholders in CER using real-world data are underdeveloped. Our experience suggests that an inclusive, stakeholder-engaged approach enriches the research process and ensures diverse perspectives are integrated into study design and conduct. Ongoing efforts will focus on assessing long-term engagement outcomes and PSAG member satisfaction.