This study describes a needs assessment of clinical and translational research (CTR) scientists at a large, distributed, School of Medicine within a public university and affiliated clinics.

We performed an Exploratory Conversion Mixed-Methods analysis using a quantitative survey and qualitative interviews with CTR scientists across the training continuum, from early-career scholars, mid-career mentors, and senior administrators at the University of Wisconsin and Marshfield Clinics. Qualitative findings were confirmed using epistemic network analysis (ENA). A survey was distributed to CTR scientists in training.

Analyses supported that early-career and senior-career scientists have unique needs. Scientists who identified as non-White or female reported needs that differed from White male scientists. Scientists expressed the needs for educational training in CTR, for institutional support of career development, and trainings for building stronger relationships with community stakeholders. The tension between meeting tenure clocks and building deep community connections was particularly meaningful for scholars who identified as under-represented, including based on race, gender, and discipline.

This study yielded clear differences in support needs between scientists based upon their years in research and diversity of identities. The validation of qualitative findings, through quantification with ENA, enables robust identification of unique needs of CTR investigators. It is critically important to the future of CTR that scientists are provided with supports throughout the career. Delivery of that support in efficient and timely ways improves scientific outcomes. Advocacy at the level of the institution for under-represented scientists is of utmost importance.

MD-PhD training programs train physician-scientists to pursue careers involving both clinical care and research, but decreasing numbers of physician-scientists stay engaged in clinical research. We sought to identify current clinical research training methods utilized by MD–PhD programs and to assess how effective they are in promoting self-efficacy for clinical research.

The US MD–PhD students were surveyed in April–May 2018. Students identified the clinical research training methods they participated in, and self-efficacy in clinical research was determined using a modified 12-item Clinical Research Appraisal Inventory.

Responses were received from 61 of 108 MD–PhD institutions. Responses were obtained from 647 MD–PhD students in all years of training. The primary methods of clinical research training included no clinical research training, and various combinations of didactics, mentored clinical research, and a clinical research practicum. Students with didactics plus mentored clinical research had similar self-efficacy as those with didactics plus clinical research practicum. Training activities that differentiated students who did and did not have the clinical research practicum experience and were associated with higher self-efficacy included exposure to Institutional Review Boards and participation in human subject recruitment.

A clinical research practicum was found to be an effective option for MD–PhD students conducting basic science research to gain experience in clinical research skills. Clinical research self-efficacy was correlated with the amount of clinical research training and specific clinical research tasks, which may inform curriculum development for a variety of clinical and translational research training programs, for example, MD–PhD, TL1, and KL2.

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.

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.