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Understanding how to translate research discoveries into solutions for healthcare improvement is a priority of NIH-funded Clinical and Translational Science Awards (CTSA). This study, supported by one CTSA, aims to capture one process of shaping and implementing innovations to advance the timeliness and patient-centeredness of cardiovascular care. Specifically, we sought to understand a partnership between a private digital health startup company, a university innovation lab, and an academic health system’s cardiology program pursuing this goal.
The collaboration proceeded through clear phases to address the questions and challenges: problem definition, exploration and formalization of the partnership, innovation co-creation and pilot test, and scale-up planning. Phases were punctuated by key decisions, such as forming the partnership, negotiating terms of the partnership, iterating form and features of the innovation, and exploring sufficiency of its value-add for scale-up and sustainment. Key implementation concepts were apparent, including implementation strategies (e.g., champions and iterative trialing) and the implementation outcomes of acceptability, sustainment, and scale-up. Participants identified potential risks of collaboration, reflected on their co-creation process, and the value of engaging stakeholders in innovation design. Findings may inform subsequent collaborations between innovators and translational researchers.
We conducted a case study to understand the partnership; characterize the questions they pursued, their decision points, information and data sources; and identify the challenges and risks. Data were collected through a series of four focus groups with members of each partnering organization. A transdisciplinary research team iteratively worked to condense and synthesize data from audio recorded transcripts into a case narrative.
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.
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