Developing Future Clinician Scientists while Supporting a Research Infrastructure

Abstract

Background

Supporting clinical research is a national priority. Clinician scientists are rare and clinical trials in academic medical centers (AMC) often fail to meet enrollment goals. Undergraduate students interested in biomedical careers often lack opportunities to perform clinical research.

Objective

Describe an innovative undergraduate course that supports clinical research in an AMC.

Methods

The course, Clinical Research Methods and Practice, offers undergraduate students the opportunity to learn clinical research through didactic and practical experiences. The students in turn support clinician scientists’ conduct of clinical studies in an AMC. Clinician scientists receive research support and participate in mentoring sessions for students.

Results

Over seven semesters, 128 students have assisted in 21 clinical studies located in outpatient and inpatient units of two hospitals. Students identified and screened eligible patients, collected clinical data, assisted in obtaining informed consent, and transported specimens. Many of the clinician scientists have met their enrollment goals and several have been top‐enrollers in multicenter clinical trials as a result of student support.

Conclusions

The Clinical Research Methods and Practice class addresses barriers to clinical research in AMC. This may be a model for institutions committed to mentoring students early in their career and to developing infrastructures for clinical research. Clin Trans Sci 2013; Volume 6: 94–97

Introduction

Sustaining the clinical research environment and the clinician investigator are national priorities. In 2004, the National Institutes of Health (NIH) published a roadmap for medical research.1 One of the three priorities identified was Reengineering the Clinical Research Enterprise to support clinical research and to bring the promise of scientific discovery to patients in order to improve health.1

One problem facing the clinical research enterprise is the frequent failure of clinical studies in academic medical centers (AMC) to meet enrollment goals.2, 3 Under‐enrolled studies fails to answer important clinical questions but may also have a significant financial impact on AMC.2, 3 One of the barriers to patient enrollment is a lack of professional and centralized research staff to automate the recruitment process.2, 3, 4 In 2010, the NIH site clinical trials.gov listed 13,000 open trials. However, in a meeting of the national Clinical and Translational Science awardees (CTSA) consortium there was concern that, “trials are being conducted with less than maximal efficiency, thus implying a need for improvement in clinical research management at AMCs”.5 Creating a sustainable clinical research infrastructure that includes dedicated research staff is one strategy to support clinical research and clinician scientists.

The AMCs face a formidable challenge regarding the clinical science workforce.6 Clinician scientists are rare and disappearing. The Association of American Medical Colleges identified 338 academic departments with 2,097 open positions for Assistant Professors in patient‐oriented research (POR) in 2002–2004.7 During this time period, more than half of the departments could not fill open positions demonstrating the shortage of clinician scientists. Undergraduate students offer a potential opportunity to enhance the clinical science workforce. Currently, undergraduate, preprofessional students interested in health professions often lack opportunities to perform clinical research. Lack of exposure early in their training may decrease their interest in POR research as part of their careers.7 Providing early research experiences for students from diverse backgrounds is one strategy that could increase the number of individuals pursuing careers that include POR.

Objectives

We designed the Clinical Research Methods and Practice course to address both barriers associated with identification and enrollment of patients in clinical research studies and to offer undergraduate students training and exposure to clinical research studies early in their careers. Undergraduate students from disciplines including premedical, public health, prenursing and others learn core components of clinical and translational research and are exposed to a broad range of clinical research opportunities with experienced mentors. In turn, students support POR studies conducted by pediatric and obstetric clinician investigators in the AMC. Our objective is to describe the development and results of the successful implementation of this course.

Methods

Course development

The department chairs, directors of administration and research, and other pediatric and obstetric leaders developed the vision and mission for the course. Early in the design phase, the course director, a pediatric faculty member, conducted a site visit to the University of Pennsylvania where a similar program has existed in the emergency department since 1994.8, 9 Finally, through a series of stakeholder meetings, we solicited input from the research intensive clinical divisions, the division of medical ethics, the Institutional Review Board (IRB), and the Clinical Trials Office in the design of the course content. The nursing staff in the clinical settings was instrumental in defining student roles and assuring that research studies and student duties were aligned with clinical care needs of patients. Stakeholders participate in teaching aspects of the curriculum.

To attract students, the class was marketed broadly to the University community through email, student counseling centers, class presentations, and preprofessional organizations. The course was advertised to departmental clinician scientists through email communication and via several department wide presentations, including presentations at departmental career development programs and monthly research conferences.

Course leadership and management

The course director is actively engaged in patient care, trainee education, and POR and devotes part‐time effort as medical director for the course. The director reviews all student and faculty applications, IRB approved study protocols, consent documents, and research materials provided by clinician investigators. Along with a small review committee, the director selects clinical studies appropriate for student participation.

A full‐time program manager with experience as a research coordinator is responsible for ensuring that the students have completed precourse requirements including background checks, drug screening, required immunizations, certification in the health insurance portability and accountability act (HIPAA), the collaborative IRB training initiative (CITI), and other local hospital requirements. The program manager creates and maintains the student schedule for research shifts and tracks student participation and class attendance. The program manager is trained to perform all student‐required duties for each study supported and acts as a liaison between the students, investigators, research study coordinators, and the course director.

All course materials, assignments, and schedules are maintained on a Web‐based classroom. Hard copies of research materials are kept in the clinical research settings.

Students

Students are recruited from science classes, premedical society meetings, other prehealth organizations, and through former students. We also maintain information about the program on the University of Utah Department of Pediatrics website (http://medicine.utah.edu/pediatrics/research_education/index.html).

Before participating in clinical studies, students attend a mandatory orientation that reviews the expectations of the class, professionalism, training on the elements of parental permission, consent and assent, and outlines universal contact precautions for specimen handling. Students tour the clinical environments and meet the nurse managers of each unit where they will be assigned. Clinical investigators, coordinators, and the program staff orient the students to each study. During the first week, students participate in training sessions led by a certified research coordinator, member of the program staff and student intern(s) for the class. Students use a checklist to perform the research tasks required for each study. To assure a common level of competency prior to beginning independent shifts in the clinical settings, the students must pass a written exam that tests their understanding of the research‐related tasks. They also must pass an oral examination that includes a role‐play assessing the student's ability to identify and approach subjects for eligibility and conduct parental permission, consent or assent.

Students spend the majority of the course in the clinical setting. They wear hospital identification badges, blue laboratory coats embroidered with the university logo, and carry pagers.

Students record potential study subjects into a screening log. Research coordinators review the daily census and compare it with the screening log to monitor student performance screening and enrolling patients.

Weekly didactic lectures include; ethics, good clinical practice, informed consent, the role of the IRB, study design, statistics, and professionalism. All students review a published manuscript, related to one of the studies being conducted during the semester and then give a presentation to the group that analyzes and critiques the paper.

Course performance is based on (1) professionalism during clinical research shifts, (2) informed consent proficiency, (3) screening and enrollment accuracy, and (4) written and oral examinations. Students and investigators complete an evaluation at the end of the semester. These evaluations are used to further refine the course.

The students provide coverage for study enrollment 15 hours per day from 9 a.m. to midnight, seven days per week. Students work 37 weeks/year while enrolled in classes and have breaks in between semesters, spring break, fall break, Thanksgiving, and Christmas. Adherence to the schedule is imperative; failure to attend a scheduled shift may result in expulsion from the course.

Students earn 4–6 credit hours per semester based on the number of research shifts completed each week. In addition to course credit, each student receives a certificate that documents the clinical research training, and lists the studies they supported.

Investigators

Clinician investigators who wish to have students support their research studies submit an application clearly defining the proposed student role to the review committee. The studies most suitable for student involvement are those classified by the IRB as minimal or low‐risk. However, students can provide support for simple tasks of a more complicated study. Students may review charts for eligibility but do not conduct retrospective chart reviews.

When a study is accepted for the program, investigators submit an amendment to the IRB outlining the specific tasks that will be performed by the students as research personnel. Investigators are required to provide all study materials, participate in student orientation and teach or mentor students enrolled in the course at least 4 hours each semester. Investigators are also required to give contact information for research assistants, research coordinators, and principal investigators so students may contact them directly for any study specific questions that arise during recruitment. Course directors and program managers are not “on‐call” to take study specific questions.

Results

One hundred twenty‐eight students have completed the course over seven semesters. Students have supported a total of 21 studies; 13 in the pediatric emergency department, 3 in the pediatric intensive care unit, and five in the inpatient ward or outpatient clinics at two university affiliated hospitals.

Table 1 shows the number of studies that the students supported and the specific research tasks performed. In eight of the supported studies over the first two years of the program, investigators monitored student performance of patient consent. In these studies, students approached 466 patients for consent and obtained consent in 401 (86%). During the fall semester of 2011, students approached 649 patients for consent and obtained consent in 500 (77%). In one study, researchers compared student performance on consenting potential study subjects with performance by a certified research coordinator. In this particular study, students consented 80% of eligible subjects and administered and completed a survey in 75% compared with research coordinators who consented 83% and completed a survey in 77%.

Table 1.

Enrollment Data by Student Task

Student Task	Fall 2009‐Summer 2011		Fall 2011
	Number of studies	Total patients (studies with data)	Number of studies	Total patients (studies with data)
Identification/screening	13	1,198 (4)	9	10,870 (9)
Approached for consent	12	466 (8)	8	649 (8)
Obtained consent	12	899 (12)	8	500 (8)
Data collection management	13	797 (11)	9	381 (9)
Specimen handling	4	421 (4)	3	208 (3)
Study public disclosure	1	19 (1)	1	110 (1)
Total studies	19		10

Eight of the studies supported are multicenter investigations. Among these, our institution was the top enroller for three and the second highest enroller for two as a result of student participation.

Following completion of the course, many students have continued in clinical research. Of the 128 graduates, 35 are working in clinical research positions and 13 have been admitted to graduate/medical school programs in biomedical science. One student wrote, “ When I decided to enroll in the Academic Associate program my intention was to get some exposure and experience in a pediatric clinical setting. I had no idea that this class would be life changing for me, and that I would change my career path in the process. This program introduced me to the exciting world of clinical research, and I realized that this was exactly what I was passionate about. The experience, opportunities and connections that I have made throughout my participation in this program have been priceless.” Clinician investigators’ satisfaction with the program is high and over a short time period, investigators have come to view student participation as an essential element in the research infrastructure for clinical studies. Some research studies would not be feasible without the involvement of the Academic Associates. One researcher stated,“The involvement of the Academic Associates has been essential to the viability and success of our study. They have been invaluable to us because of their presence in the Emergency Department, as well as their investment and interest in the various studies ongoing within the Emergency Department. The success of our Division's research enterprise has been due in no small part to the contributions of the Academic Associates.”

After our initial start up costs, this program generates income though tuition dollars based on student credit hours and student fees. These have increased since the inception of the program and now sustain the program (Figure 1). Student fees cover background checks, drug screens, lab coats and other supplies. The tuition dollars support the program faculty and staff.

Figure 1.

Number of Students and Credit Hours Per Semester

Discussion

We describe the successful implementation of a new undergraduate course offered at our institution that introduces students to POR and supports clinical investigators at an AMC. Since the initiation of Clinical Research Methods and Practice, 128 students have completed the course and gained valuable experience in POR. Nearly 40% to date have been accepted into graduate school and/or gained employment in clinical research. Our qualitative analysis indicates that these individuals are contemplating careers that include POR, thus increasing research workforce capacity. At the same time, clinician investigators throughout the department receive valuable assistance in the process of screening, consent and enrollment of study subjects. Ultimately, our institution's research enterprise is strengthened through this sustainable program that enables clinician investigators to generate data and complete trials while training future clinical investigators.

Other programs report the success of utilizing students as research assistants and providing them with an exposure in POR. Typically, these have either been limited to a single clinical environment such as an emergency department or single area of research such as oncology trials.8, 9, 10 There are also reports on courses that are offered to graduate students who already work in the clinical environment such nursing students.11, 12, 13, 14, 15 We believe our course may be the first to provide training to a diverse group of undergraduate students engaged in research in multiple clinical arenas simultaneously.

In this model, the undergraduate students benefit in several ways. If they intend to apply to competitive biomedical graduate education programs, they are often required to demonstrate research experience or experience with patients in clinical settings. Students in our program have documentation of both. Participation in a similar program led to an increase in admission rate to medical school for students.16 To date, thirteen of our students have been accepted to graduate programs in medicine, dentistry, and nursing. Students may also benefit by exposure to new professional disciplines and may have opportunities for employment following participation in the course. Thirty‐five of our student graduates are employed as research assistants or coordinators. As the program targets undergraduates and has only been in place for two years, many students are still completing their undergraduate degrees; we anticipate more student graduates of the course to be accepted into graduate or medical school or find employment as a research assistant/coordinator in the future.

This program also achieved its goal of providing support to our clinician investigators in enrollment of study subjects. In high‐volume clinical environments clinicians often do not have time to consent study subjects and ensure complete enrollment. Use of undergraduate students has been previously shown to improve research productivity within a single division.8, 9, 16, 17, 18 In addition, these studies described the impact of the program on their clinician investigators including greater academic success in generating grant funding and support to further additional research studies. Each semester, our student enrollment has increased, enabling us to provide more coverage for POR. After only 7 semesters, this program is now well known to clinician investigators and has provided quality assistance to 21 POR studies. Several of these studies were conducted with national research networks and our investigators have been recognized as top enrollers in the networks. This type of performance in national studies increases the visibility of our investigators and will enhance their ability to participate in POR research in the future.

As with the implementation of any new program, there have been challenges. The capacity of students to perform required duties varies. Each semester we have improved the learning materials and now include templates to better support students with each study. We have also created a comprehensive system to track screening of potential study subjects, which also allows for close monitoring of the student's productivity. Finally, we have become more selective in choosing studies that are both suited to the students' learning needs and involve investigators committed the education of undergraduates.

The course also has some limitations for investigators. The utilization of students as research assistants requires restriction of duties and more careful monitoring than would be required for professional research assistants. This program has been predominately limited to low‐risk POR studies. Further investigation is needed to determine whether students can support higher‐risk studies.

Conclusion

Performing rigorous prospective POR within clinical environments requires a sustainable infrastructure. Developing a flexible infrastructure that is able to accommodate multiple studies in different settings may help sustain POR at medical institutions. We have provided a description of a new program that enhances the ability of our institution to conduct POR research and helps to develop the next generation of clinical investigators. Other institutions may consider this model as an affordable option to develop the research infrastructure by linking undergraduate students and clinician‐scientists in the clinical research enterprise.