The National Board of Medical Examiners (NBME) has instituted a new multiple choice examination in order to “certify” clinical and translational investigators. As experienced research educators, we argue that this certification process is unnecessary, values knowledge over competency, may be counter-productive, and is unlikely to achieve any worthwhile outcome. We lay out these arguments in the hope of stimulating a robust discussion among leaders, faculty, and learners engaged in clinical research education and training.

The translation of discoveries to drugs, devices, and behavioral interventions requires well-prepared study teams. Execution of clinical trials remains suboptimal due to varied quality in design, execution, analysis, and reporting. A critical impediment is inconsistent, or even absent, competency-based training for clinical trial personnel.

In 2014, the National Center for Advancing Translational Science (NCATS) funded the project, Enhancing Clinical Research Professionals’ Training and Qualifications (ECRPTQ), aimed at addressing this deficit. The goal was to ensure all personnel are competent to execute clinical trials. A phased structure was utilized.

This paper focuses on training recommendations in Good Clinical Practice (GCP). Leveraging input from all Clinical and Translational Science Award hubs, the following was recommended to NCATS: all investigators and study coordinators executing a clinical trial should understand GCP principles and undergo training every 3 years, with the training method meeting the minimum criteria identified by the International Conference on Harmonisation GCP.

We anticipate that industry sponsors will acknowledge such training, eliminating redundant training requests. We proposed metrics to be tracked that required further study. A separate task force was composed to define recommendations for metrics to be reported to NCATS.

Training for the clinical research workforce does not sufficiently prepare workers for today’s scientific complexity; deficiencies may be ameliorated with training. The Enhancing Clinical Research Professionals’ Training and Qualifications developed competency standards for principal investigators and clinical research coordinators.

Clinical and Translational Science Awards representatives refined competency statements. Working groups developed assessments, identified training, and highlighted gaps.

Forty-eight competency statements in 8 domains were developed.

Training is primarily investigator focused with few programs for clinical research coordinators. Lack of training is felt in new technologies and data management. There are no standardized assessments of competence.

This article discusses the process of defining competencies and development of a best practices training course for investigators and clinical research coordinators who conduct social and behavioral research.

The first project phase established recommendations for training in Good Clinical Practice (GCP) and was done in conjunction with representatives from 62 Clinical and Translational Science Award (CTSA) hubs. Diversity in behavioral clinical trials and differences in regulation of behavioral trials compared with clinical trials involving drugs, devices, or biologics necessitated a separate Social and Behavioral Work Group. This group worked with CTSA representatives to tailor competencies and fundamental GCP principles into best practices for social and behavioral research.

Although concepts underlying GCP were deemed similar across all clinical trials, not all areas were equally applicable and the ways in which GCP would be enacted differ for behavioral trials. It was determined that suitable training in best practices for social and behavioral research was lacking.

Based on the training need, an e-learning course for best practices is available to all CTSA sites. Each institution is able to track outcomes for its employees to help achieve standardized competency-based best practices for social and behavioral investigators and staff.

This study describes the design, operation, and evaluation of a community-based research (CBR) consult service within the setting of a Clinical and Translational Science Award (CTSA) institution. To our knowledge, there are no published evaluations of a CBR consult service at a CTSA hub.

A CBR consult service was created to support faculty, health-care providers/research coordinators, trainees, community-based organizations, and community members. A framework was developed to assess the stages of client engagement and to foster clear articulation of client needs and challenges. A developmental evaluation system was integrated with the framework to track progress, store documents, continuously improve the consult service, and assess research outcomes.

This framework provides information on client numbers, types, services used, and successful outreach methods. Tracking progress reveals reasons that prevent clients from completing projects and facilitates learning outcomes relevant to clients and funding agencies. Clients benefit from the expert knowledge, community connections, and project guidance provided by the consult service team, increasing the likelihood of study completion and achieving research outcomes.

This study offers a framework by which CTSA institutions can expand their capacity to conduct and evaluate CBR while addressing challenges that inhibit community engagement.

The Learning Health System Network clinical data research network includes academic medical centers, health-care systems, public health departments, and health plans, and is designed to facilitate outcomes research, pragmatic trials, comparative effectiveness research, and evaluation of population health interventions.

The Learning Health System Network is 1 of 13 clinical data research networks assembled to create, in partnership with 20 patient-powered research networks, a National Patient-Centered Clinical Research Network.

Herein, we describe the Learning Health System Network as an emerging resource for translational research, providing details on the governance and organizational structure of the network, the key milestones of the current funding period, and challenges and opportunities for collaborative science leveraging the network.

A pilot study by 6 Clinical and Translational Science Awards (CTSAs) explored how bibliometrics can be used to assess research influence.

Evaluators from 6 institutions shared data on publications (4202 total) they supported, and conducted a combined analysis with state-of-the-art tools. This paper presents selected results based on the tools from 2 widely used vendors for bibliometrics: Thomson Reuters and Elsevier.

Both vendors located a high percentage of publications within their proprietary databases (>90%) and provided similar but not equivalent bibliometrics for estimating productivity (number of publications) and influence (citation rates, percentage of papers in the top 10% of citations, observed citations relative to expected citations). A recently available bibliometric from the National Institutes of Health Office of Portfolio Analysis, examined after the initial analysis, showed tremendous potential for use in the CTSA context.

Despite challenges in making cross-CTSA comparisons, bibliometrics can enhance our understanding of the value of CTSA-supported clinical and translational research.

Systematic review and analysis of definitions of translational research.

The final corpus was comprised of 33 papers, each read by at least 2 reviewers. Definitions were mapped to a common set of research processes for presentation and analysis. Influence of papers and definitions was further evaluated using citation analysis and agglomerative clustering.

All definitions were mapped to common research processes, revealing most common labels for each process. Agglomerative clustering revealed 3 broad families of definitions. Citation analysis showed that the originating paper of each family has been cited ~10 times more than any other member.

Although there is little agreement between definitions, we were able to identify an emerging consensus 5-phase (T0–T4) definition for translational research. T1 involves processes that bring ideas from basic research through early testing in humans. T2 involves the establishment of effectiveness in humans and clinical guidelines. T3 primarily focuses on implementation and dissemination research while T4 focuses on outcomes and effectiveness in populations. T0 involves research such as genome-wide association studies which wrap back around to basic research.

We used systematic review and analysis to identify emerging consensus between definitions of translational research phases.

Interdisciplinary collaboration is a critical component of translation, dissemination, implementation, and improvement (TDII) science. Yet, little is known about effective frameworks and practices regarding interdisciplinary research in TDII.

This study drew on data collected from an expert panel during a regional symposium.

Findings highlight facilitators and barriers to stimulating interdisciplinary TDII research in different domains: intrapersonal, interpersonal, organizational, power and hierarchy, physical environment, and communication and language.

Findings have significant implications for TDII of clinical practices.

The National Center for Advancing Translation Science (NCATS) is implementing a new strategic management plan called the results-based accountability framework. This framework is part of the common metrics initiative. For successful implementation and adoption of new management strategies, it is important to assess current stakeholders’ experiences and needs.

Interviews were conducted with principal investigators who are conducting research and supported by the Center for Clinical Translational Science at the University of Utah. Between July and August 2016, 15 interviews were completed and audio recorded. A qualitative content analysis was conducted on the transcripts.

Results indicated the need to provide education about the continuum of clinical translational research; time constraints during pre-award; barriers to IRB submissions; difficulty balancing other responsibilities in academic health centers; and the need for shared study coordinator resources.

Implementing a new management philosophy requires an understanding key stakeholders attitudes and needs. The research identified ways to help engage investigators with centralized resources supported by NCATS and implementation of common metrics at this university.