Abstract
Purpose
The development, structure, and implementation of an innovative residency program designed to help meet a growing need for pharmacists with specialized expertise in investigational drug use and clinical research are described.
Summary
Clinical research has become an increasingly complex field, but prior to 2017 there were no U.S. specialty residency training programs focused on pharmacists’ role in drug development and the care of patients enrolled in clinical trials. In 2016 Johns Hopkins Hospital (JHH) launched an initiative to develop residency training standards specific to the areas of investigational drug use and clinical research. The residency development process consisted of creation of a residency development committee; a needs assessment, including formation of a diverse panel of internal and external experts to guide identification of key competency areas and development of residency goals and objectives; design of the program’s structure, including a framework for required and elective rotations; submission of an application for pre-candidate status to the ASHP Commission on Credentialing; and recruitment efforts.
Conclusion
The JHH investigational drugs and research residency, a combined PGY1 and PGY2 program with 5 competency areas, 14 goals, and 49 objectives, was granted pre-candidate status by ASHP in November 2016. The first resident began the program in June 2017.
Keywords: investigational drugs, investigational drug services, residency
KEY POINTS
The increasing complexity of clinical research provides a landscape for the expansion of pharmacy services in the care of patients enrolled in clinical trials.
There are limited pharmacist training opportunities that focus on the provision of patient care services for patients enrolled in clinical trials and the management of investigational products.
The establishment of an investigational drugs and research residency program can provide increased training opportunities that will better equip pharmacists to provide care to clinical trial enrollees.
Clinical research in the form of clinical trials continues to be a key avenue for the development of new, safe, and effective treatments. As of March 28, 2019, there were a total of 301,497 studies registered on ClinicalTrials.gov and 50,291 studies actively recruiting study subjects.1 The vast majority of those trials (238,821 studies, or 79%) are interventional studies researching drugs or biological therapies. During a 2010 workshop focused on transforming clinical research in the United States, the Institute of Medicine Forum on Drug Discovery, Development, and Translation described current challenges with clinical research as including the need to navigate administrative and regulatory requirements, a shrinking clinical research workforce, issues related to recruitment and education of patients, the globalization of clinical research, and rising costs.2
Pharmacists play a crucial role in supporting clinical research. Within the health-system setting, the investigational drug service (IDS) pharmacy is responsible for the management of drugs used in clinical trials. The American Society of Health-System Pharmacists (ASHP) and Hematology/Oncology Pharmacy Association (HOPA) have both published guidelines outlining the role of pharmacists in the investigational drug research process.3,4 Both guidelines recognize the vital role of pharmacists and pharmacy technicians in the management of investigational drug products but do not describe the additional roles pharmacists can have in clinical research. In a national survey of pharmacy services provided in oncology clinical trials, respondents identified significant gaps between current pharmacy services provided and pharmacy services perceived to be important for patients enrolled in clinical trials.5 In particular, the largest gaps in pharmacist involvement were seen in investigator-initiated trial development, medication reconciliation, therapeutic drug monitoring, and assessment of patients’ adherence to medications used as part of a study. One of the most commonly cited barriers to implementation of pharmacist involvement in clinical trials was the lack of pharmacist training specific to that practice area.
Prior to 2017, there were no specialty residency training programs focused on investigational drugs and research. Only a small proportion of pharmacy students and pharmacy residents have access to IDS training due to limited classroom instruction and the elective nature of an IDS rotation as part of an advanced pharmacy practice experience or postgraduate year 1 (PGY1) pharmacy residency training. The goal of an investigational drugs and research residency training program is to meet the increasing need for expertise in this specialty area of practice in order to expand the role of pharmacists in clinical research.
Background and initial steps
The Johns Hopkins Hospital (JHH) is a large academic medical center in Baltimore, Maryland. Within the department of pharmacy, the IDS division supports inpatient and outpatient clinical research. In 2018, the JHH IDS staff provided support for over 600 institutional review board (IRB)–approved clinical trials involving a drug, half of which were new studies approved over the previous year.
To guide development of a clinical research–focused residency program, a residency development committee (RDC) was formed. The committee comprised key members of the pharmacy administration, the director of the analytical pharmacology core laboratory, IDS pharmacists, and a health-system pharmacy administration resident. The committee was responsible for leading the creation of the residency program, including the initial background research, development of the goals and objectives, rotation design, and recruitment efforts. Committee members had a range of skills and experiences, including IDS practice, clinical research beyond IDS, residency program development, and residency program leadership. In addition, key members of the pharmacy leadership were included, as their support was critical for program implementation. The residency development process began with a needs assessment that consisted of an evaluation of current IDS training opportunities and the use of an expert panel to help identify important research roles and key competencies for pharmacists.
Traditionally, training for IDS pharmacists primarily has consisted of on-the-job training due to the lack of residency training programs in this specific field. There are many fellowship programs focused on medical research, but most have limited to no focus on the provision of patient care services to patients enrolled in clinical trials and the management of investigational drug products.
Panel of experts
To validate the need for an investigational drugs and research residency and to provide direction for the program, a panel of experts (both internal and external to JHH) were invited to participate in a 1-day summit. The roster incorporated multidisciplinary representatives from diverse areas of clinical research: clinical pharmacists caring for patients enrolled in clinical trials, a regulatory affairs specialist, drug development scientists, IRB members, research administrators, principal investigators, clinical research nurses, and practicing IDS pharmacists. Participating experts were affiliated with a variety of external organizations, including the Food and Drug Administration (FDA), National Institutes of Health (NIH), a biopharmaceutical research company, and an IDS department at a peer institution. Broad representation on the panel was sought in order to incorporate various viewpoints of the clinical research process, which allowed the panel to assess the need for a novel residency program that provided experiences beyond those of traditional IDS practice.
The panel consisted of 22 members, who convened on January 11, 2015. The majority of the summit was divided into 4 discussion sessions based on potential residency competency areas: (1) patient care, (2) research protocols and regulations, (3) leadership and management, and (4) teaching, education, and dissemination of knowledge. Each discussion topic began with survey questions that asked the panelists to “rate the importance of a pharmacist participating on the biomedical research team through the following role.” The questions highlighted roles involving traditional investigational drug services, as well as roles beyond investigational drug product management. Panelists’ response options were “less important,” “important,” and “very important.” The survey questions were answered anonymously via mobile devices; not all questions were answered by all panel members (Table 1).
Table 1.
Results of Expert Panel Survey on Pharmacist Roles in Biomedical Research, by Competency Areaa
| Pharmacist Roles | Very Important | Important | Less Important |
|---|---|---|---|
| Patient Care | |||
| Patient and caregiver education (n = 18) | 16 (89) | 1 (6) | 1 (6) |
| Monitor patients for the presence of drug interaction, adherence to protocol, and changes in organ function (n = 19) | 14 (73.5) | 2 (11) | 3 (16) |
| Review patient profiles for medication therapy problems (n = 19) | 12 (63) | 6 (32) | 1 (5) |
| Prepare and dispense medication (n = 18) | 8 (44) | 5 (28) | 5 (28) |
| Facilitate continuity of care when patients experience transition of care (n = 18) | 5 (28) | 6 (33) | 7 (39) |
| Participate in patient visit activities (n = 18) | 5 (28) | 2 (11) | 11 (61) |
| Manage drug shortage situations (n = 19) | 3 (16) | 11 (58) | 5 (26) |
| Research Protocols and Regulations | |||
| Resource for drug information questions (n = 19) | 12 (63) | 5 (26) | 2 (11) |
| IRB committee member and other research-related committees (n = 17) | 10 (59) | 5 (29) | 2 (12) |
| Participate in protocol development (n = 18) | 10 (56) | 7 (39) | 1 (6) |
| Review protocol for adherence to institution-specific regulations (n = 19) | 7 (37) | 9 (47) | 3 (16) |
| Support coordinating center activities (n = 12) | 4 (33) | 7 (58) | 1 (8) |
| Review protocol for adherence to federal and state regulations (n = 18) | 5 (28) | 11 (61) | 2 (11) |
| Leadership and Management | |||
| Participate in the planning and implementation of services to improve and/or expand care for research patients (n = 16) | 10 (62) | 6 (38) | 0 |
| Understand the institution’s strategic plan for clinical research and participate in developing departmental goals to support the strategic plan (n = 16) | 8 (50) | 5 (31) | 3 (19) |
| Participate in budgeting and billing processes for pharmacy services (direct and indirect costs) (n = 16) | 8 (50) | 4 (25) | 4 (25) |
| Participate in the evaluation of technology to support clinical trial services (e.g., robotics, information technology, compounding equipment) (n = 17) | 7 (41) | 8 (47) | 2 (12) |
| Monitor and analyze quality assurance data for the department (n = 17) | 6 (35) | 6 (35) | 5 (30) |
| Participate in grant writing (n = 18) | 3 (17) | 8 (44) | 7 (39) |
| Education and Dissemination of Knowledge | |||
| Communication with the institution’s clinical research leadership (n = 18) | 16 (89) | 2 (11) | 0 |
| Provide clinical trial protocol education to the pertinent healthcare providers (e.g., research nurses, non-IDS pharmacists) (n = 15) | 9 (60) | 5 (33) | 1 (7) |
| Actively participate in national biomedical research organizations (n = 17) | 6 (35) | 8 (47) | 3 (18) |
| Manuscript writing and publication (n = 19) | 4 (21) | 10 (53) | 5 (26) |
aData are number and percentage of respondents; for some items, percentages do not sum to 100% due to rounding. IDS = investigational drug service, IRB = investigational review board.
Panelists’ responses demonstrated the importance of pharmacists communicating with the institution’s clinical research leadership, as 89% of respondents (16 of 18) described this role as very important. Within the patient care competency area, patient and caregiver education was recognized as a very important role by 89% of the panelists (16 of 18), and “monitoring patients for the presence of drug interactions, adherence to protocol, and changes in organ function” was considered very important by 74% of respondents (14 of 19). There was only limited discussion on adjusting current practice to allow pharmacists to perform these additional responsibilities, but panelists felt strongly that the resident should observe, learn, and perform many of these duties during training. These results were used to develop and prioritize the residency goals and objectives.
The expert panel demonstrated overwhelming support for the development of a residency program focused on investigational drugs and research. There was also strong support for developing practitioners with the skills and knowledge necessary to fulfill not only the current scope of IDS pharmacist responsibilities but also an increasing scope, to include progressive clinical roles in caring for patients enrolled in clinical trials.
Program details
Competency areas, goals, and objectives.
The RDC used several resources when creating the competency areas, goals, and objectives (CAGOs). Resources included outcomes from the expert panel meeting, PGY1 and postgraduate year 2 (PGY2) goals and objectives for ASHP-accredited residency programs in other specialties, and ASHP and HOPA guidelines on the role of an IDS pharmacist.3,4 The CAGOs include elements of investigational product management as well as advanced pharmacist roles in clinical research that were discussed during the expert panel meeting. The RDC developed the CAGOs to emphasize an increasing role for pharmacists in providing direct patient care to individuals enrolled in clinical trials.
Five competency areas were identified for the investigational drugs and research residency program at JHH, including patient care (3 goals and 14 objectives); advancement of practice and improving patient care (2 goals and 8 objectives); leadership and management (3 goals and 8 objectives); teaching, education, and dissemination of knowledge (2 goals and 6 objectives); and research protocols and regulations (4 goals and 13 objectives).
The first 4 of the 5 identified competency areas listed above are elements of all PGY2 programs; the fifth was specifically identified for the new program. The goals and objectives for the first 4 competency areas were adapted from the 2018 ASHP PGY2 residency CAGO template to focus on patients enrolled in clinical trials. For example, the goals and objectives within the patient care competency area are intended to expand the clinical knowledge gained in PGY1 training and provide experience using these skills specifically for patients enrolled in clinical trials. Skills to be achieved in this competency area include the ability to interact effectively with the research team, analyze eligibility criteria, monitor patients for safe and effective adherence to a research protocol, manage transitions of care, and manage the dispensing of investigational products. In addition, 1 goal and 3 objectives were added to the leadership and management competency area with the aim of requiring a resident to demonstrate skills in financial management and budgeting of pharmacy services for clinical trials.
The fifth competency area, research protocols and regulations, is not a component of the ASHP PGY2 residency CAGO template but was developed specifically for the new residency program. This section highlights the skills unique to the role of a pharmacist in supporting clinical trial research that are not addressed in the other 4 competency areas. Goals within this section focus on the resident demonstrating an ability to participate in the research protocol development process and assess the feasibility of pharmacy department support of the study protocol. Additional skills required within this section include participating in a sponsor site visit as the pharmacy representative for the research team, participating in the IRB review process, demonstrating adherence to ethical standards for the conduct of research, and the ability to evaluate applicable federal, state, and institution regulations as they pertain to clinical trials.
Within the 5 competency areas there are 14 goals and 49 objectives for the resident to achieve. The RDC created the competency areas, goals, and objectives to be generalizable to IDS practice at institutions across the United States.
Program structure
. It was determined that the investigational drugs and research residency at JHH would be a combined PGY1 and PGY2 program, in which the resident would receive a PGY1 pharmacy residency and a PGY2 investigational drugs and research certificate. The decision for the combined structure was multifactorial. First, the combined 2-year structure allows the resident to acclimate to a complex healthcare system, obtain strong clinical skills, and become proficient in providing care to both patients enrolled in a clinical trial and clinical patient populations. The 2-year time frame allows residents to understand the differences in various unique specialty patient populations and adapt their approach accordingly. In addition, the life cycle of most clinical trials is much longer than 1 year. Having the resident at the same institution for 2 years allows him or her to experience and support more aspects of a clinical trial in a linear process. While the RDC decided to make the JHH program a combined 2-year residency, the CAGOs could be completed as a standalone PGY2 program.
During the first year, the resident completes all required goals and objectives of the PGY1 pharmacy residency program along with a few additional responsibilities designed to prepare him or her for PGY2 training. At JHH, all PGY1 residents complete rotations in internal medicine, critical care, ambulatory care, and pharmacy leadership. During the first year, the investigational drugs and research resident also completes an IDS pharmacy rotation and a medication quality and outcomes rotation.
Some elements of the residency program are longitudinal, spanning both years of the program. First, throughout the 2-year residency program the resident completes weekend staffing requirements in the JHH adult oncology pharmacy, which serves the largest number of JHH patients enrolled in clinical trials. Second, the resident’s research project is designed as a 2-year project to allow the resident to complete and implement a project of larger scale than could be completed in 1 year. Initially, the research projects focus on identifying gaps in care for patients enrolled in clinical trials and the impact of implementing expanded pharmacy services. A project committee is established for each resident project, with members including content experts, IDS staff, and individuals who have previously participated on a pharmacy resident research committee.
The second year of the residency is structured to provide the resident with a broad-based understanding of various parts of the clinical research process and the opportunity to be actively involved in various phases of clinical research. To achieve the PGY2 goals and objectives, the program includes the following core rotations:
IDS operations (2 rotations)
Drug development—clinical pharmacology
Drug development, research clinical decision support and medication safety
Clinical research office
Johns Hopkins Office of Human Subjects Research
Longitudinal outpatient clinics
Patient care team
IDS leadership and management
The program also includes the following elective rotations:
FDA Office of Clinical Pharmacology (at the time of writing, the availability of this rotation was pending completion of an affiliation agreement)
NIH (National Cancer Institute) and pharmaceutical management
Biopharmaceutical research company, pharmaceutical industry, and drug discovery and development (rotation to be offered pending completion of an affiliation agreement)
Clinical research is supported by a number of different healthcare disciplines; therefore, the PGY2 resident completes rotations with not only pharmacy staff but also physicians, nurses, and research administrators. For example, the clinical research office rotation is completed with the director of clinical research administration. The JHH clinical research office facilitates the development of new clinical trials and management of ongoing clinical trials, including regulatory support and quality assurance activities. The drug development rotation is completed with the director of the division of pharmacology, who has a medical degree. Activities during these rotations include working with pharmacology fellows on the development of new research protocols, supporting the creation of a research grant, and spending time with a clinical research nurse to actively participate in the consent process. To provide additional support and ensure that all required components of a pharmacy resident’s rotation are completed, the residency program director (RPD) works closely with nonpharmacy staff members. The RPD collaborates with the preceptor(s) to develop the rotation descriptions and assure compliance with ASHP residency requirements. Most rotations during the second year are also 1 month in duration, with the exception of a 3-month rotation block and the longitudinal outpatient clinic rotation. The 3-month rotation block integrates rotations in drug development, research clinical decision support, and medication safety; the longitudinal block approach was primarily chosen because, due to the nature of drug development, a 1-month duration might not provide the desired depth and breadth of experience. The clinical decision support and medication safety rotations were included in the longitudinal experience because they are complementary, as a significant number of the medication safety reviews result in modifications to the electronic health system, which can take longer than 1 month to implement.
Program implementation
Applying for pre-candidate status.
During the fall of 2016, JHH submitted an application to the ASHP Commission on Credentialing for pre-candidate status (this status denotes that an organization has submitted an application notifying the commission that it intends to begin a residency program and start trainee recruitment). As there was no precedent for an investigational drugs and research residency program, JHH followed a new process designed by ASHP to specifically evaluate novel residency programs in a new practice area. The new process includes an extended application requiring applicants to provide evidence that the planned residency program targets a distinct area of practice that would benefit from the availability of a specialty residency program. Along with the extended application, ASHP requires draft CAGOs and information on the structure of the program. Following submission of the application, members of the JHH RDC and select members of the ASHP Commission on Credentialing had a follow-up meeting to further discuss the application. During the meeting, the overall research infrastructure at JHH was described, and additional detail was provided on how the program would offer opportunities for the resident to complete the necessary goals and objectives. There was also discussion about JHH’s recruitment strategy and perceived interest among potential applicants. As a result, the ASHP Commission on Credentialing granted the new residency program pre-candidate status on November 1, 2016. Obtaining pre-candidate status allowed JHH to participate in the Personnel Placement Service event during the 2016 ASHP Midyear Clinical Meeting. This was a critical component of the national recruitment strategy, which resulted in 14 applicants to the program during its first year.
In March 2017, through the ASHP Resident Matching Program, JHH matched with the first investigational drugs and research resident, who began the program in June 2017. The program has continued to be successful in the matching process since implementation.
Early experience and future directions
Key factors during program development that led to the successful implementation of the residency included creating a RDC with a diverse background, working with nonpharmacists to create unique rotation experiences, providing early education on the program to other members of the pharmacy department and potential preceptors, and initiating contact with ASHP about the novel program early in the development process. An area for improvement includes creating a realistic time line for the development of new CAGOs and the creation of the rotation structure, including rotation descriptions, as these 2 steps took longer than initially planned.
For other institutions interested in implementing an investigational drugs and research residency, it is critical to gain support from key stakeholders internal to the pharmacy department as well as externally. The external contacts are key in providing the resident with a variety of experiences in clinical research. To align the rotation experiences with the goal of the program, it is also essential that all preceptors understand the purpose of the program, including both PGY1 and PGY2 preceptors.
Members of the RDC have had preliminary conversations with representatives of several academic medical centers who are pursuing the development of an investigational drugs and research residency at their institution. To support the development of additional investigational drugs and research residency programs and increase consistency among programs, JHH is offering resources and guidance to institutions developing an investigational drugs and research residency.
Overall, the establishment of an investigational drugs and research residency program can provide increased training opportunities that will better equip pharmacists to provide care to patients enrolled in clinical trials.
Conclusion
The JHH investigational drugs and research residency, a combined PGY1 and PGY2 program with 5 competency areas, 14 goals, and 49 objectives, was granted pre-candidate status by ASHP in November 2016. The first resident began the program in June 2017.
Disclosures
The project described was supported in part by NIH grants P30 CA006973 and UL1 TR 001079. Grant UL1 TR 001079 is from the National Center for Advancing Translational Sciences (NCATS), a component of NIH and the NIH Roadmap for Medical Research. The authors have declared no potential conflicts of interest.
Additional information
The contents of this article are solely the responsibility of the authors and do not necessarily represent the official view of the Johns Hopkins Institution for Clinical and Translational Research, NCATS, or NIH.
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