Randomized clinical trials (RCT) are the foundation for medical advances, but participant recruitment remains a persistent barrier to their success. This retrospective data analysis aims to (1) identify clinical trial features associated with successful participant recruitment measured by accrual percentage and (2) compare the characteristics of the RCTs by assessing the most and least successful recruitment, which are indicated by varying thresholds of accrual percentage such as ≥ 90% vs ≤ 10%, ≥ 80% vs ≤ 20%, and ≥ 70% vs ≤ 30%.

Data from the internal research registry at Columbia University Irving Medical Center and Aggregated Analysis of ClinicalTrials.gov were collected for 393 randomized interventional treatment studies closed to further enrollment. We compared two regularized linear regression and six tree-based machine learning models for accrual percentage (i.e., reported accrual to date divided by the target accrual) prediction. The outperforming model and Tree SHapley Additive exPlanations were used for feature importance analysis for participant recruitment. The identified features were compared between the two subgroups.

CatBoost regressor outperformed the others. Key features positively associated with recruitment success, as measured by accrual percentage, include government funding and compensation. Meanwhile, cancer research and non-conventional recruitment methods (e.g., websites) are negatively associated with recruitment success. Statistically significant subgroup differences (corrected p-value < .05) were found in 15 of the top 30 most important features.

This multi-source retrospective study highlighted key features influencing RCT participant recruitment, offering actionable steps for improvement, including flexible recruitment infrastructure and appropriate participant compensation.

Pragmatic trials aim to speed translation to practice by integrating study procedures in routine care settings. This study evaluated implementation outcomes related to clinician and patient recruitment and participation in a trial of community paramedicine (CP) and presents successes and challenges of maintaining pragmatic study features.

Adults in the pre-hospital setting, emergency department (ED), or hospital being considered for referral to the ED/hospital or continued hospitalization for intermediate-level care were randomized 1:1 to CP care or usual care. Referral and enrollment data were tracked administratively, and patient characteristics were abstracted from the electronic health record (EHR). Enrolled patients completed baseline surveys, and a subset of intervention patients were interviewed. All CPs and a sample of clinicians and administrators were invited to complete a survey and interview.

Between January 2022 and February 2023, 240 enrolled patients (42% rural) completed surveys, and 22 completed an interview; 63 staff completed surveys and 20 completed an interview. Ninety-three clinicians in 27 departments made at least one referral. Factors related to referrals included program awareness and understanding the CP practice scope. Most patients were enrolled in the hospital, but characteristics were similar to the primary care population and included older and medically complex patients. Challenges to achieving representativeness included limited EHR infrastructure, constraints related to patient consenting, and clinician concerns about patient randomization disrupting preferred care.

Future pragmatic trials in busy clinical settings may benefit from regulatory policies and EHR capabilities that allow for real-world study conduct and representative participation. Trial registration: NCT05232799.

The US Food and Drug Administration (FDA) is responsible for assessing safety (risks) and effectiveness (benefits) of new drug products using the data provided in a Sponsor’s new drug product marketing application before they can be marketed. The FDA forms cross-disciplinary review teams to conduct these assessments. Recently, the FDA began implementing more interdisciplinary approaches to its assessments, reducing redundancy in review processes and documentation by increasing team integration around review issues.

Through a phenomenological descriptive comparative case study, the impact of FDA’s new interdisciplinary approach on review team integration was compared with its traditional multidisciplinary review approach.

We identified collaborative integration occurring in one FDA review team using the new interdisciplinary review and another team using the traditional review and then modeled and analyzed the collaborative, cross-disciplinary integration in each case using an input-process-output (IPO) model drawn from the Science-of-Team-Science (SciTS).

This study provides a systematic method for understanding and visualizing integration in each type of review previously and presently used at FDA and illustrates how the new interdisciplinary approach can ensure more integration than more traditional approaches previously used. In addition, our study suggests that an IPO model of integration can characterize how effectively FDA review teams are integrating around issues and assist in the evaluation of differences in integration between FDA’s new interdisciplinary review and the existing multidisciplinary approach. The approach used here is a new application of SciTS scholarship in a unique sector, and it also serves as an example for measuring review team effectiveness.

Older adults have a high disease burden but are often underrepresented in research studies due to recruitment and retention obstacles, among others. Geriatric research specialists have identified solutions to these challenges and designed frameworks to help other researchers. Our team utilized three frameworks to create an interactive webinar series aimed to educate research team members on Age-Friendly practices.

We recruited 40 non-aging-trained research team members to participate in a six-session, real-time webinar series from October to November 2022. Sessions were comprised of 20–30 minute didactics and 30–40 minute group discussions. Participants completed pre- and post-program surveys, commitment to change forms, and post-webinar session surveys. Responses were examined for strengths and areas for improvement. Wilcoxon signed-rank tests assessed differences in confidence scores.

Self-reported confidence scores improved after the webinar series. Most participants provided positive feedback and high likeliness to use what they learned and recommend the webinar to others. The strengths were practical tips, applicable tools, and real-world examples. The major area for improvement was information on industry-sponsored trials. The commitment to change responses varied from pledging to use more inclusive language to adapting materials to improve the consent process.

This interactive Age-Friendly Research webinar series was feasible and well received by participants. We created an Age-Friendly Research community fostering commitment to change clinical and translational research to be more inclusive of older adults. Future work will include more information on industry-sponsored trials and expand to other research centers.

In response to the COVID-19 pandemic, we rapidly implemented a plasma coordination center, within two months, to support transfusion for two outpatient randomized controlled trials. The center design was based on an investigational drug services model and a Food and Drug Administration-compliant database to manage blood product inventory and trial safety.

A core investigational team adapted a cloud-based platform to randomize patient assignments and track inventory distribution of control plasma and high-titer COVID-19 convalescent plasma of different blood groups from 29 donor collection centers directly to blood banks serving 26 transfusion sites.

We performed 1,351 transfusions in 16 months. The transparency of the digital inventory at each site was critical to facilitate qualification, randomization, and overnight shipments of blood group-compatible plasma for transfusions into trial participants. While inventory challenges were heightened with COVID-19 convalescent plasma, the cloud-based system, and the flexible approach of the plasma coordination center staff across the blood bank network enabled decentralized procurement and distribution of investigational products to maintain inventory thresholds and overcome local supply chain restraints at the sites.

The rapid creation of a plasma coordination center for outpatient transfusions is infrequent in the academic setting. Distributing more than 3,100 plasma units to blood banks charged with managing investigational inventory across the U.S. in a decentralized manner posed operational and regulatory challenges while providing opportunities for the plasma coordination center to contribute to research of global importance. This program can serve as a template in subsequent public health emergencies.

Unmet social needs contribute to growing health disparities and rising health care costs. Strategies to collect and integrate information on social needs into patients’ electronic health records (EHRs) show promise for connecting patients with community resources. However, gaps remain in understanding the contextual factors that impact implementing these interventions in clinical settings.

We conducted qualitative interviews with patients and focus groups with providers (January−September 2020) in two primary care clinics to inform the implementation of a module that collects and integrates patient-reported social needs information into the EHR. Questions addressed constructs within the Theoretical Framework for Acceptability and the Consolidated Framework for Implementation Research. Data were coded deductively using team-based framework analysis, followed by inductive coding and matrix analyses.

Forty patients participated in interviews, with 20 recruited at the clinics and 20 from home. Two focus groups were conducted with a total of 12 providers. Factors salient to acceptability and feasibility included patients’ discomfort answering sensitive questions, concerns about privacy, difficulty reading/understanding module content, and technological literacy. Rapport with providers was a facilitator for patients to discuss social needs. Providers stressed that limited time with patients would be a barrier, and expressed concerns about the lack of available community resources.

Findings highlight the need for flexible approaches to assessing and discussing social needs with patients. Feasibility of the intervention is contingent upon support from the health system to facilitate social needs assessment and discussion. Further study of availability of community resources is needed to ensure intervention effectiveness.

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.

Ideally, real-world data (RWD) collected to generate real-world evidence (RWE) should lead to impact on the care and health of real-world patients. Deriving from care in which clinicians and patients try various treatments to inform therapeutic decisions, N-of-1 trials bring scientific methods to real-world practice.

These single-patient crossover trials generate RWD and RWE by giving individual patients various treatments in a double-blinded way in sequential periods to determine the most effective treatment for a given patient.

This approach is most often used for patients with chronic, relatively stable conditions that provide the opportunity to make comparisons over multiple treatment periods, termed Type 1 N-of-1 trials. These are most helpful when there is heterogeneity of treatment effects among patients and no a priori best option. N-of-1 trials also can be done for patients with rare diseases, potentially testing only one treatment, to generate evidence for personalized treatment decisions, designated as Type 2 N-of-1 trials. With both types, in addition to informing individual’s treatments, when uniform protocols are used for multiple patients with the same condition, the data collected in the individual N-of-1 trials can be aggregated to provide RWD/RWE to inform more general use of the treatments. Thereby, N-of-1 trials can provide RWE for the care of individuals and for populations.

To fulfill this potential, we believe N-of-1 trials should be built into our current healthcare ecosystem. To this end, we are building the needed infrastructure and engaging the stakeholders who should receive value from this approach.

The hidden curriculum encompasses the norms, values, and behaviors within a learning environment. Navigating the hidden curricula of academia is crucial for doctoral trainees, particularly those from underrepresented backgrounds. Faculty mentors have an important role in helping trainees uncover and cope with the hidden curriculum. The purpose of this paper is to explore perceptions of the hidden curriculum among diverse doctoral trainees and mentors.

Following a presentation on the hidden curriculum at the Association for Clinical and Translational Science annual meeting in March 2021, attendees were asked to brainstorm ideas for diverse trainees and their mentors. Breakout room discussions were held for specific hidden curriculum topics; participants voted on which topics to discuss from a list of topics defined during the presentation. Ideas from these discussions were presented to the larger group to upvote.

Participants (n = 116) voted to discuss the following hidden curriculum topics: “coping with bias,” “assertive communication,” “knowing how things work,” and “developing a career.” Many suggestions emphasized the role of institutions in empowering mentors to help diverse trainees and, more generally, to meaningfully support policies and programs that facilitate the career success of trainees and faculty from underrepresented backgrounds.

This work generated a list of suggested action items for trainees, mentors, and institutions to ameliorate the hidden curricula of academia, especially for diverse trainees. However, institutions need to support changes that will facilitate these discussions as well as more broadly enable the success of faculty and students from diverse backgrounds.

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.