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The purpose of this article is to present issues associated with the education and role of clinical research managers (CRMs), an emerging and vital discipline within the clinical research field. Regardless of job titles, job descriptions, or educational backgrounds, those persons who coordinate studies at clinical research sites are now expected to perform more higher-level clinical, leadership, and management activities than ever before. Education and training opportunities in clinical research continue to range from informal on-the-job learning to various offerings of educational endeavors with some contributions leading up to terminal degrees. Clinical research curricula have not been standardized or supportive of the emerging roles of CRMs. Moreover, educational offerings depend on multiple factors including investigative site support, investigator support, funding, staffing, and workload. Attention to principles of adult learning and structured graduate coursework, interdisciplinary partnership approaches, and research generated from within this discipline supports the growing professionalism of the CRM as a fundamentally essential member of the clinical research team. Consensus an educational programs pursuant to the CRM preparation is needed and recommendations for site, institution, and sponsor support ere given.
Key words: clinical research, clinical research manager, nurse coordinator, research education, research nurse, study coordinator, training
Introduction and background
Clinical research constitutes a large sector of the health care industry and employs a significant number of the burdened health care workforce. The biomedical research industry spends an estimated $38 billion worldwide annually. Approximately 20,000 people participate in human studies per year, but the impact of clinical research is broader, affecting therapies and guidelines for treatments at exponential rates. (1) Concomitant with the growth and reach of clinical research is the increased complexity of clinical studies, treatment modalities, and an upsurge in technology, what one author described as an "information explosion." (2) Moreover, bioethical dilemmas continue to mirror this pace--such as incidences of scientific misconduct, human subject violations, and compromised trial results leading to more complex regulatory oversight and reporting requirements. Scientific misconduct has been related to workload, training, and supervision issues. (3) Resolution of those issues seems simple at first glance; however, adequately addressing those issues requires deliberate and consistent approaches and evaluation of outcomes. Given the continued problems cited by the Office of Inspector General (OIG) regarding ethical violations in clinical research, the need to focus on formal or focused education and training for all levels of clinical researchers is being recognized. However, the OIG does not mandate training and/or supervision of clinical trial staff by investigators or institutions. (3) Dramatic clinical research events recently have impacted clinical research manager (CRM) work as well. For example, FDA has taken several potential blockbuster products off of the market or pharmaceutical sponsors have prematurely terminated trials because of late adverse event findings. (4,5)
Target audiences for clinical research education and training are often those persons who are currently active in clinical research. Formal education in clinical research for undergraduates and graduates often is not available to persons who are not currently employed in these areas. The experience of persons entering clinical research positions for the first time likewise ranges from novice to experienced health care professionals with little or no prior clinical research training to non-health care professionals. (6) Regardless of job titles, job descriptions, or educational backgrounds, persons who coordinate studies at clinical research sites are expected to perform clinical, leadership, and management activities. Clinical research training, at a minimum, should embody the principals and standards of Good Clinical Practice (GCP), ethics, and federal regulations. Additional education and training should include clinical research methodology, biostatistics, managing complex clinical and ethical decision-making, and clinical research site management. A recent publication described this role as CRM because today's large clinical trials are conducted globally in a variety of non-U.S. sites with a broader range of personnel involved in day-to-day operations of research protocols. (1) For instance, in low-resource countries, medical doctors are more highly involved in study coordinating compared to U.S. counterparts. (1,7) The term CRM also has begun to be used on academic websites, such as Duke University School of Nursing (www.nursing.duke.edu). Although CRM may be a more appropriate evolutionary job title, most U.S. sites continue to use the term study coordinator. Unfortunately, this term may be associated with a service- or task-oriented role in the United States rather than a professional role into which it has now evolved. Discussing professionalism in clinical research may be a key step in advancing this evolving discipline, mandating and defining education and training pathways. (8) For the purpose of this paper, CRM will be used to describe the role of those persons performing study coordination activities for clinical trials at the professional level often demonstrated by nurses, medical doctors, pharmacists, and other licensed health care professionals worldwide.
Education and training opportunities in clinical research continue to range from informal seat-of-the-pants, trial-by-fire, on-the-job learning to various offerings of educational endeavors contributing to terminal degrees. (7) Clinical research curricula have not been standardized. Likewise, the methods used to train employees on GCPs and clinical research site management topics depend on a variety of factors such as funding, investigative site support, and investigator support of CRM training, as well as staffing and workload at the site. Most CRMs conduct studies within academic medical centers; however, a growing number of CRMs are also employed in private practice clinics and contract research organizations (CROs). (1,9)
The types and levels of clinical trial sponsors also vary--a reality that impacts training too. Clinical trials on drugs, devices, or biologics are sponsored by large pharmaceutical corporations, smaller biotech companies, non-government organizations, government funding, or any combination of the above. Some sponsors may rely on third parties, such as contract research organizations, to implement study-specific activities, such as the training mandated by regulations and guidelines for the study site personnel. Other trials are small investigator-initiated, single or limited site studies, including medical, nursing, public health, social science, and education research. These may lack specific sponsorship beyond the site institution. The broad spectrum of sponsor size, investment, and focus equates to highly variable training and education.
Without consistency in clinical research training programs, CRMs have gaps in clinical research knowledge. Certainly CRMs employed in academic institutions may have more access to education opportunities, but they are not guaranteed higher levels of training than their non-academic site counterparts. Within some academic institutions, various departments and divisions function with the silo mindset--not interacting nor developing common standards for educating CRMs. Without common standards, it is difficult to have uniform job titles, salary ranges, and roles. Within a single institution, clinical research training often is limited to minimally required protection of human subjects training and HIPAA training purely to meet evidence of documentation and not necessarily the comprehension and validation of continuing education.
A number of factors limit implementation of CRM training. Experienced faculty and trainers who are specialized in clinical research education are rare to find. A shortage of CRMs corresponds to the shortage in nursing, especially nursing education and other health care staff. Given such shortages of CRMs, there may be little opportunity for new hires to be trained by existing experienced personnel. Additionally, there are limited opportunities for CRMs to have training through preceptorships or mentoring. Institutions and investigator acknowledgement and support of coordinator training often are inconsistent. Because training is not necessarily valued or required for CRM …