Education and training of clinical research professionals and the evolution of the Joint Task Force for Clinical Trial Competency.

Clinical research professionals play a critical role in the design, conduct, and oversight of clinical trials, and they must have the knowledge, skills, and abilities to ensure that trials are conducted ethically, safely, and in accordance with regulatory requirements. As clinical research has evolved from being a necessary activity for the development and regulatory approval of new medicines to an accredited academic discipline and, more recently, to a globally recognized profession, the methods of education and training of professionals have also evolved. Initially, on-the-job informal coaching and specialized training organizations led to formalized and accredited academic degree programs and, more recently, to international competency standards and competency maintenance through continuous professional development. The Joint Task Force (JTF) for Clinical Trial Competency is a multidisciplinary, international group of experts who came together to aggregate and refine competency standards for clinical research professionals, first published in 2014. The 8 domains and 49 specific core competencies of the JTF Framework have become a globally recognized standard upon which education and training programs, role descriptions, and upward mobility criteria for professionals are now based. The JTF meets regularly and, through its workgroups, continues to evolve in response to the changing needs of the profession. The JTF is committed to continuous improvement to ensure that clinical research professionals have the competence necessary to conduct safe, ethical, and high-quality clinical research.

Description of Cryptococcosis Following SARS-CoV-2 Infection: A Disease Survey Through the Mycosis Study Group Education and Research Consortium (MSG-19).

BACKGROUND: Invasive fungal infections have been described throughout the COVID-19 pandemic. Cryptococcal disease after infection with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) has been reported in several isolated case reports and 1 larger case series. We sought to describe cryptococcal infections following SARS-CoV-2 through establishing a database to investigate underlying risk factors, disease manifestations, and outcomes. METHODS: We created a crowdsourced call for cases solicited through the Mycoses Study Group Education and Research Consortium, the Centers for Disease Control and Prevention Emerging Infectious Diseases Network, and infectious diseases Twitter groups. Data were collected in a web-based and secure REDCap survey without personal identifiers. RESULTS: Sixty-nine cases were identified and submitted by 29 separate institutional sites. Cryptococcosis was diagnosed a median of 22 days (interquartile range, 9-42 days) after SARS-CoV-2 infection. Mortality among those with available follow-up was 72% (26/36) for the immunocompetent group and 48% (15/31) for the immunocompromised group (likelihood ratio, 4.01; P = .045). We observed a correlation between disease manifestation (central nervous system infection, proven/probable disseminated disease, and respiratory) and mortality (P = .002). CONCLUSIONS: The mortality rate of 59% for patients with cryptococcosis following SARS-CoV-2 is higher than that of modern Cryptococcus cohorts. There was an association between immunocompromised status and cryptococcal disease manifestations as well as mortality. Moreover, our series emphasizes the need for clinical and laboratory assessment of opportunistic infections beyond 30 days when concerning symptoms develop.

Clinical Trial Site Perspectives and Practices on Study Participant Diversity and Inclusion.

Clinical trial participant populations fail to adequately represent target populations that drugs are intended to serve. Improving racial and ethnic diversity of clinical trial participants is essential for generalizable, quality clinical research results and ensuring social and medical equity. Site-level clinical research professionals (CRPs) have unique insights on diversity improvement strategies for clinical trial enrollment. A survey was distributed to current CRPs working at clinical research sites in the United States to describe current practices and perceptions of the impact these practices have on participant diversity. Subsequently, descriptive quantitative analysis and inductive content analysis were performed. For the practices surveyed, there are discrepancies between frequency of use and perceived impact on diversity enrollment. Common current practices include phone-based or telemedicine study visits, electronic/digital data collection, and participant compensation. However, we report travel reimbursement and services, translated documents and translator services, and adequate participant compensation as most impactful on diverse enrollment. A multistakeholder approach is necessary to enhance diversity and inclusion (D&I) of study participants. Besides large-scale solutions such as countering community distrust, actionable steps are needed by sponsors and study sites to improve D&I of trial participants. Study leadership at the sponsor, contract research organization (CRO), and site-level should create diversity plans prior to study start, and CRO and sponsor budgets should consider D&I strategies during study planning. Planning should incorporate strategies to improve D&I including adequate participant compensation, translated documents and translator services, and travel reimbursements.

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.

Issues for recruitment and retention of clinical research professionals at academic medical centers: Part 1 - collaborative conversations Un-Meeting findings.

Background: Identification of evidence-based factors related to status of the clinical research professional (CRP) workforce at academic medical centers (AMCs) will provide context for National Center for Advancing Translational Science (NCATS) policy considerations and guidance. The objective of this study is to explore barriers and opportunities related to the recruitment and retention of the CRP workforce. Materials and Methods: Qualitative data from a series of Un-Meeting breakout sessions and open-text survey questions were analyzed to explore barriers and recommendations for improving AMC CRP recruitment, retention and diversity. Results: While certain institutions have established competency-based frameworks for job descriptions, standardization remains generally lacking across CTSAs. AMCs report substantial increases in unfilled CRP positions leading to operational instability. Data confirmed an urgent need for closing gaps in CRP workforce at AMCs, especially for attracting, training, retaining, and diversifying qualified personnel. Improved collaboration with human resource departments, engagement with principal investigators, and overcoming both organizational and resource challenges were suggested strategies, as well as development of outreach to universities, community colleges, and high schools raising awareness of CRP career pathways. Discussion: Based on input from 130 CRP leaders at 35 CTSAs, four National Institute of General Medical Sciences' Institutional Development Award (IDeA) program sites, along with industry and government representatives, we identified several barriers to successful recruitment and retention of a highly trained and diverse CRP workforce. Results, including securing institutional support, champions, standardizing and adopting proven national models, improving local institutional policies to facilitate CRP hiring and job progression point to potential solutions.

A Care Step Pathway for the Diagnosis and Treatment of COVID-19-Associated Invasive Fungal Infections in the Intensive Care Unit.

BACKGROUND: In March 2020, the World Health Organization declared COVID-19, caused by the SARS-CoV-2 virus, a pandemic. Patients with severe cases resulting in hospitalization and mechanical ventilation are at risk for COVID-19-associated pulmonary aspergillosis, an invasive fungal infection, and should be screened for aspergillosis if they have persistent hemodynamic instability and fever. Early detection and treatment of this fungal infection can significantly reduce morbidity and mortality in this population. OBJECTIVE: To develop an evidence-based care step pathway tool to help intensive care unit clinicians assess, diagnose, and treat COVID-19-associated pulmonary aspergillosis. METHODS: A panel of 18 infectious disease experts, advanced practice registered nurses, pharmacists, and clinical researchers convened in a series of meetings to develop the Care Step Pathway tool, which was modeled on a tool developed by advanced practice nurses to evaluate and manage side effects of therapies for melanoma. The Care Step Pathway tool addresses various aspects of disease management, including assessment, screening, diagnosis, antifungal treatment, pharmacological considerations, and exclusion of other invasive fungal coinfections. RESULTS: The Care Step Pathway tool was applied in the care of a patient with COVID-19-associated aspergillosis. The patient was successfully treated. CONCLUSION: The Care Step Pathway is an effective educational tool to help intensive care unit clinicians consider fungal infection when caring for COVID-19 patients receiving mechanical ventilation in the intensive care unit, especially when the clinical course is deteriorating and antibiotics are ineffective.

Nurses in clinical trials: perceptions of impact on the research enterprise.

Background: Clinical Research Nurses practice across a wide spectrum of roles and settings within the global research enterprise. Clinical Research Nurses working with clinical trials face a dual fidelity in their role, balancing integrity of the protocol and quality care for participants. Aims: The purpose of this study was to describe Clinical Research Nurses' experiences in clinical trials, educational preparation, and career pathways, to gain a deeper understanding of clinical research nursing contributions to the clinical research enterprise. Methods: An internet-based survey was conducted to collect demographic data and free text responses to four open-ended queries related to the experience of nurses working in clinical trials research, educational preparation, and role pathways. Qualitative content analysis was used to analyze free text responses. The study was guided by the Clinical Research Nursing Domain of Practice and Duffy's Quality Caring Model of relationship centered professional encounters. Results: Forty clinical research nurses responded to the open-ended questions with themes related to dual fidelity to study participants and protocols, relationships and nursing care, interdisciplinary team membership and contributing to science, emerging from the data. Gaps in educational preparation and professional pathways were identified. Conclusion: This study provides insights to unique clinical research nurse practice contributions in the clinical trial research enterprise within a context of Duffy's Quality Caring Model.

Development and evaluation of a clinical research nursing module for undergraduate nursing schools: expanding Clinical Research Nurses' outreach.

Background: Clinical Research Nurses (CRNs) care for study participants and manage clinical research studies; yet the CRN practice role is rarely covered in undergraduate nursing curricula in the United States. Despite a burgeoning need for CRNs, the pipeline of clinical research nurse positions remains sparse. The International Association of Clinical Research Nurses's (IACRN) strategic goal to "engage with nursing schools to heighten awareness and inclusion of the CRN role competencies in nursing education" prompted the development of an educational lecture module to be disseminated to nursing schools. This project is a pilot launch of the module. Methods: A task force of IACRN was formed to develop educational materials that could be used as outreach to undergraduate nursing schools. The content included a slide presentation covering an overview of clinical research, the CRN practice, three embedded videos showing CRN and study participant perspectives, and coverage of the care of participants of research by staff nurses. Due to COVID-19 we revised our live lecture approach using either a live synchronous webinar presentation, or an embedded asynchronous course module with YouTube videos for course learning management systems. We presented the content to 408 nursing students attending three academic programs. To evaluate effectiveness and satisfaction, an anonymous, post-presentation survey using web-based QualtricsXM was distributed to students. Results: Content and delivery of the module was positively evaluated. There was an improvement in knowledge in each topic. Evaluation responses showed that the content could likely or very likely improve care for their patients (87.4%) and improve patient education for patients in clinical trials (95%). Conclusions: Delivering a synchronous or asynchronous module about the CRN practice role to nursing students in academic nursing programs is valuable to increasing awareness of the care of patients in clinical trials, the CRN role, and future professional development.

Creating and testing a GCP game in an asynchronous course environment: The game and future plans.

INTRODUCTION: The National Institute of Health has mandated good clinical practice (GCP) training for all clinical research investigators and professionals. We developed a GCP game using the Kaizen-Education platform. The GCP Kaizen game was designed to help clinical research professionals immerse themselves into applying International Conference on Harmonization GCP (R2) guidelines in the clinical research setting through case-based questions. METHODS: Students were invited to participate in the GCP Kaizen game as part of their 100% online academic Masters during the Spring 2019 semester. The structure of the game consisted of 75 original multiple choice and 25 repeated questions stemming from fictitious vignettes that were distributed across 10 weeks. Each question presented a teachable rationale after the answers were submitted. At the end of the game, a satisfaction survey was issued to collect player satisfaction data on the game platform, content, experience as well as perceptions of GCP learning and future GCP concept application. RESULTS: There were 71 total players who participated and answered at least one question. Of those, 53 (75%) answered all 100 questions. The game had a high Cronbach's alpha, and item analyses provided information on question quality, thus assisting us in future quality edits before re-testing and wider dissemination. CONCLUSIONS: The GCP Kaizen game provides an alternative method for mandated GCP training using principles of gamification. It proved to be a reliable and an effective educational method with high player satisfaction.

The DIAMOND portal: An innovative platform for sharing translational research workforce training and assessment resources.

Although several initiatives have produced core competency domains for training the translational science workforce, training resources to help clinical research professionals advance these skills reside primarily within local departments or institutions. The Development, Implementation, and AssessMent of Novel Training in Domain (DIAMOND) project was designed to make this training more readily and publicly available. DIAMOND includes a digital portal to catalog publicly available educational resources and an ePortfolio to document professional development. DIAMOND is a nationally crowdsourced, federated, online catalog providing a platform for practitioners to find and share training and assessment materials. Contributors can share their own educational materials using a simple intake form that creates an electronic record; the portal enables users to browse or search this catalog of digital records and access the resources. Since September 2018, the portal has been visited more than 5,700 times and received over 280 contributions from professionals. The portal facilitates opportunities to connect and collaborate regarding future applications of these resources. Consequently, growing the collection and increasing numbers of both contributors and users remains a priority. Results from a small subset of users indicated over half accomplished their purpose for visiting the site, while qualitative results showed that users identified several benefits and helpful features of the ePortfolio.

Indices of Clinical Research Coordinators' Competence.

INTRODUCTION: There is a clear need to educate and train the clinical research workforce to conduct scientifically sound clinical research. Meeting this need requires the creation of tools to assess both an individual's preparedness to function efficiently in the clinical research enterprise as well as tools to evaluate the quality and effectiveness of programs that are designed to educate and train clinical research professionals. Here we report the development and validation of a competency self-assessment entitled the Competency Index for Clinical Research Professionals, version II (CICRP-II). METHODS: CICRP-II was developed using data collected from clinical research coordinators (CRCs) participating in the "Development, Implementation and Assessment of Novel Training In Domain-Based Competencies" project at four clinical and translational science award (CTSA) hubs and partnering institutions. RESULTS: An exploratory factor analysis identified a two-factor structure: the first factor measures self-reported competence to perform routine clinical research functions while the second factor measures competence to perform advanced clinical functions. We demonstrate the between groups validity by comparing CRCs working in different research settings. DISCUSSION: The excellent psychometric properties of CICRP-II, its ability to distinguish between experienced CRCs at research intensive CTSA hubs and CRCs working in less intensive community-based sites coupled with the simplicity of alternative methods for scoring respondents make it a valuable tool for gauging an individual's perceived preparedness to function in the role of CRC as well as an equally valuable tool to evaluate the value and effectiveness of clinical research education and training programs.

Joint Task Force for Clinical Trial Competency and Clinical Research Professional Workforce Development.

Clinical research workforce development efforts have focused on both increasing the size of the workforce of investigators and professionals working in the clinical research enterprise, but also the education and training of those individuals to ensure the quality of study performance to improve the public's health. A major contribution to these efforts has been the establishment of core competencies for clinical research professionals by the Joint Task Force for Clinical Trial Competency. This article reviews the development of the clinical research core competencies, their wide adoption and influence on job descriptions, education, training, and academic accreditation.

Interventional cardiologists: Beware and be aware: An updated report of radiation-induced cutaneous cancers.

We describe 5 years of follow-up of a previously reported case of disabling ionizing radiation (IR)-related cutaneous cancer in a high-volume interventional cardiologist. This case illustrates the cycle of exposure, disease, remission, and re-exposure that demonstrates the cause-and-effect relationship between radiation exposure and cutaneous cancer. Prior cautions for working in environments with radiation exposure emphasized strict adherence to the ALARA principle and called for improved radiation protection equipment. New studies stress that radiation exposure should be as near to zero as possible and place a call for research and technologies that mitigate the use of IR for all interventionists.

Enhancing research capacity for global health: evaluation of a distance-based program for international study coordinators.

INTRODUCTION: Due to the increasing number of clinical trials conducted globally, there is a need for quality continuing education for health professionals in clinical research manager (CRM) roles. This article describes the development, implementation, and evaluation of a distance-based continuing education program for CRMs working outside the United States. METHODS: A total of 692 applications were received from CRMs in 50 countries. Of these, 166 were admitted to the program in two cohorts. The program, taught online and in English, included 4 required and 1 optional course. Course materials were also provided as hard copies and on CDs. A pretest/posttest design was used to evaluate the outcome of the program in terms of changes in knowledge, participants' capacity-building activities at their research sites; and participant and supervisor perceptions of program impact. RESULTS: Participants demonstrated significant improvements in knowledge about clinical research, rated course content and teaching strategies positively, and identified the opportunity for interactions with international peers as a major program strength. Challenges for participants were limited time to complete assignments and erratic Internet access. Participants offered capacity-building programs to 5061 individuals at their research sites. Supervisors indicated that they would recommend the program and perceived the program improved CRM effectiveness and site research capacity. DISCUSSION: Results suggest that this type of continuing education program addresses a growing need for education of CRMs working in countries that have previously had limited involvement with global clinical trials.