Carolynn Thomas Jones

Cutaneous Cancers in an Interventional Cardiologist: A Cautionary Tale

This case report documents the presentation of a disabling ionizing radiation (IR)-related illness (multiple basal cell carcinoma [BCC] syndrome) in a 50-year-old interventional cardiologist. This case emphasizes the need for interventionalists to: (1) understand the occupational hazards of IR; (2) recognize the failure of existing protective gear to provide sufficient protection from IR; (3) promote strict adherence to IR safety protocols; and (4) call for the development of improved technology for radiation protection.

Education and training of clinical and translational study investigators and research coordinators: A competency-based approach

Introduction 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. Methods Clinical and Translational Science Awards representatives refined competency statements. Working groups developed assessments, identified training, and highlighted gaps. Results Forty-eight competency statements in 8 domains were developed. Conclusions 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.

Research nurse manager perceptions about research activities performed by non-nurse clinical research coordinators

OBJECTIVES There has been limited research to document differences in roles between nurses and non-nurses who assume clinical research coordination and management roles. Several authors have suggested that there is no acknowledged guidance for the licensure requirements for research study coordinators and that some non-nurse research coordinators may be assuming roles that are outside of their legal scopes of practice. There is a need for further research on issues related to the delegation of clinical research activities to non-nurses. METHODS This study used nominal group process focus groups to identify perceptions of experienced research nurse managers at an academic health science center in the Southern United States about the clinical research activities that are being performed by non-nurse clinical research coordinators without supervision that they believed should only be performed by a nurse or under the supervision of a nurse. RESULTS A total of 13 research nurse managers volunteered to be contacted about the study. Of those, 8 participated in two separate nominal group process focus group sessions. The group members initially identified 22 activities that they felt should only be performed by a nurse or under the direct supervision of a nurse. CONCLUSIONS After discussion and clarification of results, activities were combined into 12 categories of clinical research activities that participants believed should only be performed by a nurse or under the direct supervision of a nurse.

Alignment of Competencies to Address Inefficiencies in Medicines Development and Clinical Research: Need for Inter-Professional Education

The challenges faced by the biopharmaceutical industry in its key role to overcome the bottlenecks in innovative medicines development are related to addressing the technical knowledge gaps, the limitations to clinical trial testing, and the lack of clarity in the global pathways and processes to efficient outcomes. It is postulated that the lack of an adequately sized and appropriately trained multi-professional workforce, both in the industry and in the clinical research field, to enable fulfillment of the demanding aims for medicines development is a significant part of the problem. The current global status of pharmaceutical medicine’s efforts to conduct education and training is seen as patchy, inadequate, and without recognition, direction or leadership. It is therefore proposed that the movement towards competency-based education (CBE) should be harnessed, and core competency job and role profiles and competency curricula should be developed. CBE presents a means of addressing the educational and training needs within medicines development, harmonizing the workforce and the requirement for increased inter-professional teamwork. An educational environment in which aspiring and established biomedical professionals could readily learn about the competencies they need to pursue a particular career path is envisioned. Utilizing competencies provides the building blocks to align and harmonize the desired learning outcomes for effective performance amongst a multi-professional workforce. The effective implementation of training programs as described here has the potential to transform drug development procedures into an efficient and integrated process; medical product life-cycle management would result in the availability of better and safer medicines more rapidly, for the benefit of patients and society.

Moving from Compliance to Competency

Medicines development and clinical research are among the most heavily regulated activities on a global basis. As our understanding of pathophysiology and therapeutic intervention has increased, there has been a concomitant increase in the complexity of clinical trial protocol requirements[1][1] and

Global Self-Assessment of Competencies, Role Relevance, and Training Needs Among Clinical Research Professionals

The Joint Task Force for Clinical Trial Competency conducted a multinational survey of clinical research professionals as a first step toward validating its previously published framework. Participants self-assessed their competence level and the relevance of specific core competencies to their current professional activities, as well as their perceived need for further training to enhance performance quality. Significant differences in the perception of competence and relevance for the role were observed among the various members of the clinical research team.

Evolving the PICOT Method for the Digital Age: The PICOT-D.

BACKGROUND Many articles written about the PICOT (Population, Intervention, Comparison, Outcome, Time) method for developing research questions focus on searching the existing evidence base to review the impact of interventions. The PICOT method evolved to craft questions that yield operative search terms. Currently, the PICOT method falls short in its utility for health care and doctoral education. For example, the Doctor of Nursing Practice scholarly practice projects evaluate the existing evidence base and compare the current real-world state with the evidence base, for which the current conceptualization of the PICOT method has limited applicability. METHOD The PICOT-D adds digital data (D) components to the traditional PICOT, allowing for the explicit identification of data measures that form the basis of the evaluation of an intervention. RESULTS the PICOT-D has the potential to improve student efficiency, efficacy, and confidence in the development of truly answerable questions that fully support improved patient care and systems-level change. CONCLUSION This article demonstrates the need for the evolution of the PICOT format to the PICOT-D format.

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.

Academic Preparation in Clinical Research

Academic programs offering formal coursework or degrees in clinical research have increased in number over the past decade. As roles in the field of clinical research evolve, and as job titles and descriptions become standardized and professionalized, having an academic pathway to expand knowledge, skills, and abilities better prepares individuals for certification and career advancement. At this juncture in the clinical research enterprise, where the complexity of new medical product development is rapidly escalating, having a well-educated cadre of professionals is important to plan, implement, and evaluate research projects leading to innovative new treatments or diagnostics.