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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.
Clinical trials in Parkinson's disease (PD) have focused in two major areas: treatments designed to alleviate signs and symptoms in the short run, and treatments designed to modify the long-term progression of the illness. In clinical trials of short-term improvement with early PD patients the most common primary outcome measure is the Unified Parkinson's Disease Rating Scale (UPDRS). Motoric dysfunction, loss of ambulatory capability, cognitive impairment, mood disruption, and autonomic dysfunction all eventually contribute to potentially severe disability in individuals with advanced PD. Trials are just emerging that focus on the development of overall disability in PD, rather than measuring impairments in any particular domain such as motor function or cognitive impairment. Multiple trial designs have been proposed and used in studies to assess disease modification in PD. Several particular safety concerns have emerged in the context of PD clinical trials.