Journal of Clinical and Translational Science最新文献

Low enrollment of racial/ethnic minorities in clinical trials is a persistent problem. This study explores community health workers' (CHWs) potential to increase research participation by Black people. We interviewed 12 CHWs and 12 Black community members, and after multidisciplinary analysis, held a CHW focus group to refine themes and make recommendations. Most participants mistrusted research, but many valued its potential for generativity. CHW involvement in research was seen as an opportunity to bring community relationships and context to all aspects of research, including recruitment. Participants proposed steps to build trustworthy research experiences and develop CHWs as full research team members.

The Mayo Clinic Center for Clinical and Translational Science Rural Health Research Core emphasizes community engagement to address healthcare access and delivery. In 2023, the Midwest Rural Health Research Community Advisory Board (CAB) was established to guide research. Eleven of 13 researchers presenting to the CAB in 2023 completed a survey assessing influence of CAB feedback across seven domains. All reported >1 domain influenced by CAB feedback, most commonly on study design, pre-research activities and implementation. CAB feedback shaped many aspects of the rural health research process. CAB members valued seeing how their input contributed to the research process.

This commentary discusses research workforce programs designed to enhance the representation and engagement of Latinos in HIV research, highlighting key challenges and proposing actionable strategies for improvement. Mentorship education and cultural inclusivity are identified as the most salient issues because the former leads to stronger health-related outcomes and is linked to cognitive-and career-related factors while the latter offers the potential to directly dismantle structures of inequity. This commentary suggests recasting of Diversity, Equity, and Inclusion (DEI) initiatives from eligibility as Latino self-identification, to all individuals' lived experiences and/or prior experience in service/research activities. Some issues and constructs (i.e., heterogeneity, perseverance, acculturation, cultural values), typically important for certain underrepresented minoritized groups in diversity workforce programs, are reinterpreted for their relevance to all potential participants. This commentary proposes a holistic approach to trainee eligibility, creating a more inclusive environment that respects both individuality and diversity, and, importantly, contributing to DEI does not require being a member of an underrepresented minoritized population group.

Introduction: Susan G. Komen® (Komen) has invested nearly $1.1 billion in ground-breaking breast cancer research since 1982. As a patient-centered organization, Komen measures research funding impact beyond academic metrics in favor of economic value and societal effects. Here, we highlight an innovative approach to assessing the real-world impact of Komen-funded research by showing how Komen funding for pivotal studies and key personnel conducting research contributed to discovery and development of targeted therapy drugs approved to treat breast cancer by the United States Food and Drug Administration (FDA) between 2012 and 2023.

Methods: We utilized bibliometric analysis to work backwards through citations within pivotal Phase III clinical trial publications to identify earlier clinical trials, pre-clinical research, and basic research publications that supported development of each drug, evaluating each published study and contributing authors for Komen funding support.

Results: All 19 targeted therapy drugs approved by the FDA between 2012 and 2023 were impacted at multiple phases along the drug development pipeline by Komen funding, including direct impacts in basic research (i.e., investments in projects) that supported target discovery, and impacts in support of key personnel who contributed to pivotal studies and clinical trials (i.e., investments in people) that led to approval.

Conclusions: Nonprofit and public sector research funding provide the foundation for the drug development pipeline. This paper highlights an innovative approach to assess the impact of research investments beyond traditional academic measures and underscores the significance of nonprofit, patient-centered organizations like Komen in driving drug development through supporting basic and applied research.

Background: Trust in biomedical research is essential, multidimensional, and shaped by individual experiences, culture, and communication. Participants' trust relies on researchers' commitment to ethical practices. As public trust in science declines due to misinformation and disinformation campaigns, biomedical researchers (BmRs) must ensure trust and cultivate trustworthiness. This study explores BmR's perspectives on trust and trustworthiness.

Methods: We employed a qualitative, phenomenological approach to explore the experiences of BmRs. Through purposive sampling via the Indiana Clinical and Translational Sciences Institute, we invited BmRs to participate in semi-structured interviews. We employed rapid qualitative analysis (RQA) to identify key themes from interviews with BmRs. This action-oriented approach enables a research team to efficiently summarize experiences and perspectives, using structured templates and matrixes for systematic analysis and interpretation.

Results: Fourteen BmRs were interviewed. Volunteer demographics were collected for race/ethnicity, gender, faculty rank, and investigator experience level. The following domains were identified: individual trust and trustworthiness, institutional trustworthiness, and trust and equity as a crucial part of structural and social drivers of health.

Conclusion: We recognize that BmRs are dedicated to health equity and addressing disparities. However, in addition to committing to "best practices," BmRs should prioritize actions that foster genuine trust from the communities they serve. More development opportunities are needed for reflection of what it means to be trusted by research volunteers and communities. Furthermore, intentions alone aren't sufficient; earned trust and trustworthiness are vital.

Introduction: Timely dissemination of clinical trial results is essential to advance knowledge, guide practice, and improve outcomes, yet many trials remain unpublished, limiting impact. We examine what drives publication and timelines across three major clinical domains.

Methods: We analyzed study design and factors associated with dissemination of interventional trials, focusing on cardiovascular disease (CVD), cancer, and COVID-19. A total of 10,785 trials (CVD: 5929; cancer: 4210; COVID-19: 646) were linked to PubMed publications using National Clinical Trial identifiers. Study design, operational, and transparency-related features were assessed as predictors of time to publication, defined as the interval from study completion to first publication, using Cox proportional hazards model.

Results: COVID-19 trials had the highest publication rate (49.6%), followed by CVD (42.3%) and cancer (32.9%), likely reflecting pandemic-related prioritization. Faster publication was associated with larger enrollment, more sites, result posting, randomization, DMC presence, and higher blinding levels (all p < 0.05). Slower publication was linked to supportive care or diagnostic trials (CVD), basic science (cancer), and later COVID-19 trial completion. In subgroups, U.S. facility presence (CVD) and phase 3 design (cancer) predicted faster publication, while healthy volunteer inclusion (CVD) predicted slower publication. Among DMC trials, more secondary outcomes were linked to faster publication across all disease areas.

Conclusions: Key study design and operational factors consistently predict whether and when trials are published. Strengthening methodological rigor, result reporting, and multi-site collaboration may accelerate timely dissemination into peer-reviewed literature.

People with disabilities in the US are now a health disparities population. Though 25% of US adults have a disability, only 5% of medical research grants are disability related. Knowledge about researchers' perceived barriers to including people with disabilities in research has focused on a single disability/condition and thus has limited translational science applications. Our CTSA's Disability as Difference: Reducing Researcher Roadblocks (D2/R3) project examined such roadblocks towards inclusion of people with intellectual and developmental disabilities (I/DD). I/DDs are broad, heterogeneous conditions that originate in childhood, have varying impact and function, and persist throughout the lifespan. Strategies that mitigate their under-representation in research will likely have general applicability to all disabilities. In D2/R3's first phase we conducted semi-structured interviews with translational science and I/DD program leaders at ten US institutions about perceived barriers and facilitators to including people with I/DD in research. Interviews were held with 25 individuals from partnering Intellectual and Developmental Disabilities Research Centers, University Centers for Excellence in Developmental Disabilities, and Clinical and Translational Science Award programs. Collaborative thematic coding identified key themes as: attitudinal barriers (e.g., assumptions about consent capacity), logistical barriers (e.g., accommodation costs), health disparities, and generalizability concerns. Findings informed development of a survey based on Prosci's ADKAR® model of change management's five components: Awareness, Desire, Knowledge, Ability and Reinforcement. Exclusion appears to stem from researchers' lack of awareness, misconceptions, and knowledge gaps rather than insurmountable obstacles.

Background: To enhance representation in LCS research, we examined associations between participant characteristics and their preferred mode of survey completion among individuals eligible for LCS.

Methods: Between February 2023 and April 2024, prospective participants were identified using electronic healthcare records from Mass General Brigham and the University of Oklahoma Health Sciences (OUHSC). We offered three modes of survey completion: online, by mail, or by phone. Eligible participants were 50-80 years old, had smoked within the past 15 years, and spoke English or Spanish. We used multinomial logistic regression to estimate relative risk ratios (RRR).

Results: Outreach to 2,822 individuals resulted in a sample of 315 participants. The mean age was 61.7 years (SD = 10.9). Most respondents were women (63.0%) and identified as White (63.3%), 29.8 % were Hispanic. The most common survey completion mode was mail (37.1%), followed by online (35.9%) and phone (27.0%). Characteristics associated with completion by mail were study site (RRR = 6.86, 95%CI:3.10-15.14), and race (RRR = 3.63, 95%CI:1.53-8.61); with respondents at OUHSC or who did not identify as White being more likely to choose mail over online modality. Characteristics associated with phone completion, included older age (RRR = 1.11, 95% CI: 1.03-1.20), Spanish language preference (RRR = 9.28, 95%CI:2.38-36.09), and with local government or community insurance (RRR = 9.91, 95% CI:1.92-51.3).

Conclusion: The current trend toward online surveys may not fully account for individual preferences for LCS research engagement, and could limit the representativeness in LCS studies if offline alternatives are not offered.

Introduction: The National Institutes of Health Data Management and Sharing (DMS) policy (NOT-OD-21-013) mandates the submission of a Data Management and Sharing Plan (DMSP) for all NIH-funded research that generates scientific data. However, little information is available about how academic medical centers have implemented the policy.

Objectives: The study aimed to characterize our institution's implementation of the DMS policy and compare structured versus unstructured approaches to producing policy-conformant DMSPs.

Methods: We monitored all NIH grant submissions from our institution for 18 months, evaluating policy implementation through DMSP completeness and reviewer comments during the Just-in-Time period. A rubric was developed to assess whether each required DMSP element and sub-element was addressed. Eight DMSP templates (three NIH-provided, five institutionally developed) and two categories of investigator-created DMSPs were scored. Researchers' feedback was collected through surveys and interviews.

Results: 79.3% of submitted DMSPs addressed all NIH-required DMSP elements. Element-level compliance ranged from 98.9% (data type) to 82.7% (tools and software). Sub-element scores showed greater variability, with 98.9% completion for data description and 49.3% for data generation. Unstructured DMSPs consistently underperformed compared to structured DMSPs. Survey and interview feedback, along with reviewer comments, reinforced these findings.

Conclusion: A notable 20.7% of DMSPs omitted one or more required elements, indicating a need for improved DMS policy conformance. Structured DMSP templates demonstrated greater alignment with NIH policy. We recommend using structured templates to enhance the quality and consistency of data management and sharing plans.