Core Competencies for Research Training in the Clinical Pharmaceutical Sciences

INTRODUCTION

Clinical pharmaceutical research is essential for the progression of novel preclinical discoveries into meaningful changes in patient care. Scientists with the unique skills to integrate basic pharmacology and the clinical pathogenesis of disease are highly sought in academia and the pharmaceutical industry. Clinical pharmacologists' ability to integrate preclinical and clinical evidence as it relates to drug response is a key factor necessary to reduce both the time of drug development and the likelihood of late-phase drug failures.¹ As with the pharmaceutical industry, translation of preclinical research discoveries into meaningful therapeutic interventions has been a major initiative within academic settings. The creation of an infrastructure for clinical research within academic institutions by the National Institutes of Health (NIH) Clinical and Translational Science Awards (CTSA) has fueled the need for highly skilled researchers in the clinical pharmaceutical sciences.

Despite the demand by academia and the pharmaceutical industry, colleges and schools of pharmacy and medicine graduate too few researchers with skills in clinical pharmaceutical sciences and clinical pharmacology. Pharmaceutical scientists with skills in pharmacogenetics, pharmacometric modeling and simulation, clinical pharmacotherapeutics, and pharmaceutics are in short supply.^1-3 In response to this demand, the number of colleges and schools of pharmacy offering fellowship training, master's degrees, and PhD degrees in the clinical pharmaceutical sciences has grown significantly. In 2006, more than 40% of colleges or schools either offered or were planning to offer PharmD/PhD training programs in the pharmaceutical sciences.⁴ Fellowship training programs also have attempted to address the need for more clinical researchers. The ideal method to train individuals with the skills to conduct clinical and translational research within the pharmaceutical sciences has been discussed extensively.^5-7 Nevertheless, the relatively small number of trainees produced by all training programs is not meeting the needs of the research community.

In 2006, the American Association of Colleges of Pharmacy (AACP) appointed an Educating Clinical Scientists Task Force to explore how academic pharmacy can increase the capacity and impact of pharmacy researchers in clinical and translational research. This task force developed several essential policy statements focused on the education and training of future clinical pharmaceutical scientists.⁸ In 2009, a follow-up summit was held with the goal of reaching a consensus on the common and/or best practices among institutions offering clinical pharmaceutical scientist PhD training. General agreement was reached that training individuals to conduct clinical and translational research is distinctly different from training individuals with a PharmD degree to conduct traditional PhD research in the pharmaceutical sciences. In other words, the addition of a basic science PhD to a prior PharmD degree will not result in a scientist with the research skills necessary to rapidly initiate a career in clinically-oriented research. The summit participants universally agreed that clinical pharmaceutical scientist training programs need to differentiate and specify the training requirements that prepare graduates in the distinct discipline of clinical research in the pharmaceutical sciences. Furthermore, delineation of the specific core competencies for these students was deemed necessary to provide guidance for new program development and to identify the specific skills attained by individuals completing a PhD in the clinical pharmaceutical sciences.

Concurrent with the summit meetings, faculty members at the University of Pittsburgh School of Pharmacy identified the core competencies for the Clinical Pharmaceutical Scientist PhD Program. This effort was based on the need to: (1) identify the specific training requirements for PharmD and non-PharmD students entering such programs; (2) determine which courses from the University of Pittsburgh's CTSA educational offerings should be included as curricular requirements for the program; and (3) increase the clarity of the differences in research training offered by the clinical pharmaceutical sciences versus traditional graduate training. In March 2010, the University of Pittsburgh School of Pharmacy finalized the core competencies and completed a mapping of these competencies to the specific curricular and experiential offerings during training. Presented in this paper are the core competencies, the mapping of the competencies to the current curriculum, and a retrospective evaluation of written comprehensive examinations to assess the utility of these competencies in evaluating student outcomes. The experiential components of our training program and their use in the assessment of programmatic outcomes also are discussed.

DESIGN

The rationale for developing core competencies was based on a programmatic need for informed decision-making on several issues, including core course requirements, admission of non-PharmD students, and experiential requirements for clinical pharmaceutical scientist students. Since inception of the Clinical Pharmaceutical Scientist PhD Program at the University of Pittsburgh in the 1980s, 34 students have completed PhD degrees and 1 student has completed a master's degree. Of these graduates, 15 entered the program with a PharmD degree, 1 entered with a bachelor of science in nursing (BSN) degree, and 19 entered with a master or bachelor of science degree in pharmacy or another science-related discipline. The program had several informal requirements for training BS versus PharmD students; however, consensus on the specific training requirements for students based on their entry degree could not be reached. An informed group decision could not be made unless a consensus was reached on the key competencies expected of all students within the graduate program regardless of their training background. Therefore, our goal was to develop a set of core competencies to guide decision-making processes with respect to curricular and experiential requirements for the Clinical Pharmaceutical Scientist PhD Program.

Core competencies were developed using a 3-step process. First, the core competency task force was charged with identifying the key competencies necessary for completion of the Clinical Pharmaceutical Scientist PhD Program. The group was asked to develop these competencies without considering the content of currently offered courses. Once consensus on the core competencies was achieved, the group refined and mapped the competencies to the current required and elective curricular offerings in the Clinical Pharmaceutical Scientist PhD Program. The final step was to align the mapped core competencies to our previously developed assessment matrix of learning outcomes for the entire graduate program in pharmaceutical sciences.

The final core competencies then were opened for review and recommendations from all faculty members prior to implementation and dissemination. Feedback also was solicited from several students who had completed the program and had taken many of the classes being considered as requirements for the curriculum. The learning objectives for our traditional PhD program and the core competencies of our Clinical and Translational Science Institute were used as guides in the development of the core competencies described.

Eight major categories of core competencies were identified (Table 1). Under each category, specific competencies were listed. An excerpt of the full core competency document is provided in Figure 1. (The complete document is available at www.pharmacy.pitt.edu/cps). The highest levels of Bloom's Taxonomy were used to create these individual competencies at the appropriate level for graduate training outcomes. Each competency was then mapped to the curricular and experiential offerings to which it corresponded in the Clinical Pharmaceutical Scientist PhD Program.

• Download figure
• Open in new tab
• Download powerpoint

Figure 1.

Example of the University of Pittsburgh Clinical Pharmaceutical Scientist Core Competency Grid with curricular and experiential mapping. The asterisks indicate clinical pharmaceutical scientist PhD-specific competencies. Competencies not marked with asterisks represent general skills to be acquired by all pharmaceutical sciences graduate students. (www.pharmacy.pitt.edu/cps.)

A significant issue addressed by the core competency document was the identification of the elements unique to clinical pharmaceutical scientist PhD training versus traditional PhD training in the pharmaceutical sciences. The clinical pharmaceutical scientist competencies detail the skills necessary to conduct independent, hypothesis-driven, ethically sound research in humans. This skill set is the key differentiator between training in the clinical versus traditional pharmaceutical sciences. Examples of these specific skills include demonstration of the student's ability to recognize and explain the clinical and public health implications of a given research hypothesis, and the ability to identify important outcome measures to incorporate into a patient-oriented clinical trial design. Fifteen clinical pharmaceutical scientist-specific competencies were identified (Table 2).

Within the program, several curricular and experiential components are aimed at meeting specific clinical research core competencies. The curricular components specific to the clinical pharmaceutical scientist training include Introduction to Translational Research in the Health Sciences and Clinical Research Methods. Introduction to Translational Research in the Health Sciences is an interprofessional, graduate level course in which students develop and justify a line of research that can have a major impact on human health in the next 10 years. This project is completed as an interprofessional group assignment. The course provides the intellectual framework for a career in clinical and translational research. The Clinical Research Methods course, a curricular offering from the educational initiatives of the CTSA award at the University of Pittsburgh, is aimed at providing students with the skills to design, implement, and interpret clinical research. For experiential requirements, students in the Clinical Pharmaceutical Scientist PhD Program must include a human study in at least 1 aim of their written comprehensive examination. This examination requires the student to submit a written NIH R01 formatted proposal, followed by an oral defense of that proposal in front of their graduate committee. Students also are required to serve as an investigator on an Institutional Review Board submission during graduate studies. Finally, the student's dissertation research must include at least 1 chapter that involves human research as defined by the National Institutes of Health.⁹ Collectively, these experiential and curricular elements provide the foundation to achieve the identified competencies of the Clinical Pharmaceutical Scientist PhD Program. As we move forward with these identified core competencies, our intent is to assess the entire curriculum and experiences to ensure the desired outcomes.

EVALUATION AND ASSESSMENT

To use the core competencies for assessment purposes, we developed a rubric for the comprehensive examination (Appendix 1). Fourteen core competencies were associated with the comprehensive examination, 6 of which were specific to the clinical pharmaceutical scientist PhD. The goal of this assessment was to identify how many of these 14 core competencies were met by past written examinations, and to identify areas of strengths and weaknesses in our past written proposals. To accomplish this goal, we obtained the written comprehensive examinations of 12 previous clinical pharmaceutical science graduate students. These 12 proposals were selected based on the availability of the written documents from the students who had most recently successfully completed the Clinical Pharmaceutical Scientist PhD Program. Two faculty members graded each of the 12 comprehensive examinations, which yielded 24 assessments. All of the examinations were de-identified prior to grading. The examinations were graded on a scale of 5 (excellent) to 1 (unsatisfactory) for each of the competencies. The average scores for each competency were determined and the percentage of examinations receiving an average score of less than 3 (satisfactory) also was determined. The results are provided in Table 3.

The majority of the core competencies for the written comprehensive examination were achieved (Table 3). Eleven of the 14 competencies were met by the majority of students and had mean scores greater than 3.8 on a 5-point scale. Three areas in which students were not consistently meeting the new competencies were identified. Two of these were related to human rights protection and subject recruiting: (1) develop appropriate methods to recruit and retain study participants for the selected research design, and (2) demonstrate knowledge of the standards of professional and ethical conduct established to guide researchers in protecting the rights, well-being, and dignity in the recruitment and retention of human subjects in clinical research. Although these competencies were being addressed in other portions of the curriculum, we thought that these competencies should be addressed by the capstone comprehensive examination. Therefore, the guidelines for comprehensive proposals now emphasize that the human rights protections section is included (as described by NIH guidelines).¹⁰ Emphasis of this section ensures that this competency will be assessed as part of our comprehensive examination process in the future.

The third competency that was not being met fully was the evaluation of possible problems in design and execution of a study in the pharmaceutical sciences. Although this competency was being addressed in the oral defense of the written proposal, the evaluation revealed that several proposals failed to include a specific section detailing the potential limitations of the proposed work. Therefore, the guidelines for the comprehensive examination now specify that the written proposals include a subsection covering potential limitations after discussing the anticipated results to ensure that this competency is being addressed. The comprehensive examination rubric now is made available to graduate students to provide additional, previously undisclosed, guidance as they prepare for this capstone assessment. We intend to use a similar on-going assessment approach to evaluate all curricular and experiential requirements and adjust content as needed to ensure achievement of these competencies.

DISCUSSION

In this manuscript we describe the core competencies for clinical pharmaceutical scientist training developed at the University of Pittsburgh. It is our intent that these competencies can be used to guide faculty members and others to ensure that the quality, consistency, and expectations of training are being met through curricular and experiential requirements. Specifically, the core competencies will be used to develop methods to assess both curricular and experiential components of our Clinical Pharmaceutical Scientist PhD Program. Externally, the competency document will help clarify previously unresolved questions about clinical pharmaceutical scientist training. For example, the 2009 Summit on Clinical Pharmaceutical Scientists Training Programs concluded that training a PharmD to do traditional PhD research in the pharmaceutical sciences differs from specific training in the clinical pharmaceutical sciences. While the position generally was agreed upon, a description of specific clinical pharmaceutical science core competencies had not been previously delineated. As a result, the lines have become blurred regarding what constitutes clinical pharmaceutical scientist training. It is our intent to use these core competencies as a guide to define which specific courses and experiences clearly differentiate clinical pharmaceutical scientist training. Such information will be useful for other schools of pharmacy as a guide for the development of competencies associated with new training programs at their institutions. This information also may prove valuable to refine educational initiatives associated with CTSA and other clinical research educational initiatives.

Another issue raised at the 2009 Summit was the need to train both pharmacists and nonpharmacists in the clinical pharmaceutical sciences. In order to have a significant impact on clinical research and secure support for such programs, colleges and schools of pharmacy need to train both PharmD and nonPharmD students in the clinical pharmaceutical sciences. Although there is general consensus on this issue, the specific curricular and experiential requirements for a student entering our program with or without a PharmD degree were not clearly detailed. Because the developed core competencies apply to all students in the clinical pharmaceutical sciences, the competencies will provide a framework for informed decision-making about the curricular and experiential requirements necessary to train all students entering the program regardless of the entry-level degree earned.

SUMMARY

Core competencies were developed for graduate training in the Clinical Pharmaceutical Scientist PhD Program at the University of Pittsburgh School of Pharmacy. We describe the use of these competencies for rubric development and assessment of our capstone written comprehensive examination. Through this process, we identified areas for improvement in our comprehensive examination process, thereby developing additional guidelines to ensure that all competencies are addressed. In addition, development of these competencies has allowed the specific skills that differentiate training in the clinical pharmaceutical sciences from traditional pharmaceutical science PhD training to be defined.