How do clinical research coordinators learn Good Clinical Practice? A mixed-methods study of factors that predict uptake of knowledge.

BACKGROUND: Good Clinical Practice is an international standard for the design and conduct of clinical trials to ensure ethical and scientific integrity. Recent National Institutes of Health policy mandates Good Clinical Practice training for all investigators and staff involved in National Institutes of Health-funded clinical trials, yet approaches to Good Clinical Practice training vary widely. There are limited data on Good Clinical Practice knowledge among the clinical trial workforce and no evidence regarding effective methods to learn Good Clinical Practice. METHODS: We used an exploratory sequential mixed-methods design. We conducted 18 exploratory qualitative interviews with clinical research coordinators to help inform the development of the quantitative survey. We then administered a validated 32-item, multiple-choice test of Good Clinical Practice knowledge with a survey of work and training experiences to 625 clinical research coordinators at three academic medical centers in the United States. Variables that were significantly associated with Good Clinical Practice knowledge were entered into a multiple regression analysis to identify unique predictors of Good Clinical Practice knowledge. We controlled for verbal-numerical reasoning and learning orientation. RESULTS: During qualitative interviews, clinical research coordinators reported that formal Good Clinical Practice training had value but they simultaneously emphasized the importance of experience, day-to-day practice, and observing colleagues and mentors as essential to supplement formal training. In our quantitative survey, five variables predicted a total of 22% of variance in Good Clinical Practice knowledge scores: years of experience as a clinical research coordinator, working on diverse types of trials, supporting industry-funded trials, being certified in clinical research coordination, and aggregated hours of online and face-to-face training (in that order). CONCLUSION: The duration and richness of experience as a clinical research coordinator were the strongest predictors of Good Clinical Practice knowledge, a finding consistent with our exploratory qualitative interview results. Our findings suggest that formal online and face-to-face training has a minimal influence on Good Clinical Practice knowledge. The type of training-whether online or face to face-does not make a significant difference in Good Clinical Practice knowledge scores. Much of the variance in Good Clinical Practice knowledge remains unexplained, calling for further research in this area.

Academic medical center clinical research professional workforce: Part 2 - Issues in staff onboarding and professional development.

Background: Defining key barriers to the development of a well-trained clinical research professional (CRP) workforce is an essential first step in identifying solutions for successful CRP onboarding, training, and competency development, which will enhance quality across the clinical and translational research enterprise. This study aimed to summarize barriers and best practices at academic medical centers related to effective CRP onboarding, training, professional development, identify challenges with the assessment of and mentoring for CRP competency growth, and describe opportunities to improve training and professionalization for the CRP career pathway. Materials/Methods: Qualitative data from a series of Un-Meeting breakout sessions and open-text survey questions were analyzed to explore the complex issues involved when developing high-quality onboarding and continuing education opportunities for CRPs at academic medical centers. Results: Results suggest there are several barriers to training the CRP workforce, including balancing foundational onboarding with role-based training, managing logistical challenges and institutional contexts, identifying/enlisting institutional champions, assessing competency, and providing high-quality mentorship. Several of these themes are interrelated. Two universal threads present throughout all themes are the need for effective communication and the need to improve professionalization of the CRP career pathway. Conclusion: Few institutions have solved all the issues related to training a competent and adaptable CRP workforce, although some have addressed one or more. We applied a socio-technical lens to illustrate our findings and the need for NCATS-funded academic medical centers to work collaboratively within and across institutions to overcome training barriers and support a vital, well-qualified workforce and present several exemplars from the field to help attain this goal.

Assessing clinical research coordinator knowledge of good clinical practice: An evaluation of the state of the art and a test validation study.

This paper describes the development and validation of a new 32-item test of knowledge of good clinical practice (GCP) administered to 625 clinical research coordinators. GCP training is mandated by study sponsors including the US National Institutes of Health. The effectiveness of training is rarely assessed, and the lack of validated tests is an obstacle to assessment. The GCP knowledge test was developed following evaluation of two existing widely used GCP tests to ensure it accurately reflects the content of current training. The final GCP knowledge test demonstrated good reliability (α = 0.69). It is a valid and reliable instrument for measuring knowledge of GCP. The test will be useful in assessing the effectiveness of GCP training programs as well as individuals' mastery of GCP content.

Asthma exacerbations after glucocorticoid withdrawal reflects T cell recruitment to the airway.

We reasoned that a prospective assessment of glucocorticoid withdrawal in subjects with asthma would provide insight into the basis for flares of the disease. We therefore enrolled 25 subjects with moderate persistent asthma and treated them for 30 days with inhaled fluticasone propionate (1,760 microg/day) followed by a withdrawal period that lasted until peak expiratory airflow decreased by 25% and FEV(1) by 15% or 6 weeks elapsed. After glucocorticoid withdrawal, 13 of 25 subjects reached the target, whereas 12 subjects did not. The number of eosinophils in bronchial biopsies was increased by glucocorticoid withdrawal in both groups, but increases in airway T cells were found in only those with exacerbation. T-cell accumulation was a reflection of similar increases in both CD4(+) and CD8(+) T cells and was accompanied by increased expression of chemokine CCL5 (regulated upon activation, normal T cell expressed and secreted) in the airway epithelium without activation of the transcription factor nuclear factor-kappaB. The pattern of glucocorticoid-sensitive inflammation during an asthma exacerbation is more reminiscent of an antiviral response than an eosinophil-predominant response to allergen and implies an independent role for airway T cells in mediating asthma flares and in determining glucocorticoid efficacy in the treatment of this disease.