Clinical Researcher—June 2022 (Volume 36, Issue 3)

PEER REVIEWED

Nadina C. Jose, MD; Doreen Waldron Lechner, PhD; Barbara Tafuto, MLS, PhD; Lisa Palladino Kim, MS

 

Clinical research workforce development efforts require a focus on the education and training of clinical research professionals who ensure the quality of study performance to improve the public’s health and instill trust in the outcomes of these studies. Academic research medical institutions are charged with the development of this educational pipeline along with the academic and career continuum. Graduate research education is a crucial step in the pursuit of crafting educational programs that will best prepare young scientists and biopharma industry professionals for careers in clinical and translational research.{1} A final “capstone” project within a master’s program can improve upon a curriculum that successfully meets the advanced level competencies.{2}

Formal academic clinical research degrees based on comprehensive competencies provide students a sense of security of being trained. Additionally, adherence to the Joint Task Force (JTF) Clinical Research Professional Competency Framework promotes the minimum standards required for accreditation of such degrees intended to enhance the quality of education of clinical research professionals.{3}

This article focuses on how one graduate school’s MS Clinical Research Management program includes a capstone project which involves a final presentation, poster, or manuscript on a topic based on concepts learned throughout the program. The project is tracked through a project plan that contains timelines, deliverables, and anticipated risks, as well as its proposed mitigations, methodology for implementation, and projected outcomes. The capstone project deliberately targets principles of leadership and professionalism encompassing communications and teamwork skills necessary to successfully conduct clinical trials as outlined in Domains 7 (Leadership and Professionalism) and 8 (Communication and Teamwork) of the JTF Competency Framework.{4}

The COVID-19 pandemic resulted in a considerable barrier for students’ ability to implement their capstone projects under normal processes. Barriers that relate to leadership, professionalism, communication, and teamwork presented significant challenges. Two students (Student 1 and Student 2) projected to complete their capstone project in 2020 at their respective companies were precluded from implementing their projects onsite due to complete lockdown and strict quarantine rules related to COVID-19. Such a challenge required the instant application of advanced level of communication, leadership, and professionalism to successfully complete a project in the unchartered environment of the virtual space.

The objective of this paper is to track the journey of these students who were faced with the burden of having to readjust their capstone project activities while in lockdown at the height of the COVID-19 pandemic, by highlighting the tools they used to cope with the rigors of meeting the project deliverables.

Methods

Student 1 was required to fulfill the following obligations to meet their capstone project: 1) create a mapping tool for real-world evidence (RWE) by accessing proprietary databases through a company’s secure portal, 2) create a checklist of data-cleaning rules/points for an RWE database, and 3) collaborate and participate with the company’s in-house RWE team on insight generation activities that will align with the mapping tool.

While parameters and tasks were initially set before COVID-19 hit that would have allowed face-to-face engagement with relevant stakeholders and onsite access to proprietary databases, Student 1 adjusted the project plan by setting up the tasks to be performed remotely. Bi-weekly calls with the faculty content advisor and weekly virtual meetings with the company preceptor were immediately initiated even before the official start date of the capstone project.

Student 1 needed to get approval for the project adjustments and sought assistance for additional accommodation on submitting deliverables. Timelines for deliverables were reset, and a table of constraints with projected mitigation techniques was implemented. A communication plan was established for scheduled virtual meetings with multiple stakeholders from the RWE team, which had to adjust its own projects involving healthcare providers from whom the insights needed by Student 1 were going to be generated. Student 1 had to ensure a continuous flow of information to complete the project requirements despite the limited access to both the stakeholders and the databases.

The capstone project for Student 2 required the following obligations: 1) assessing the impact of COVID-19 on Medical Affairs’ activities of insight generation, stakeholder engagement, and scientific exchange at a specific company, 2) revamping the roles and responsibilities of the company’s medical science liaisons to adapt to the shift caused by the pandemic,{5} and 3) developing an innovative system for stakeholder engagement.

Student 2 adjusted project timelines and deliverables based on securing regular virtual meetings with relevant company decision makers who were also on lockdown with limited access to the company’s secure portal. Weekly meetings with both the preceptor and faculty adviser were conducted as information from both public and private sources were being collected.

Student 2 escalated issues to company executives as needed by the project, especially when facing opposition due to the company also being on lockdown with heightened internet security checks that it was not prepared to endure with all of its employees working remotely. The project included developing an innovative program of activities needed to be performed virtually to keep the community of clinical stakeholders aligned with the company’s products.

For 15 weeks, the only means of communication and delivery of the work done by Student 1 and Student 2 were via the school’s learning management system, e-mails, video conference calling, and telephone. Apart from discussions about each of their project’s status, each student was queried on the status of their health, home life, and overall mental state as the COVID-19 pandemic worsened throughout 2020 and global conditions such as the economy, emotional state, family life, and overall well-being were hampered.

Reliance on technology, close collaboration with both their preceptors and faculty advisor, and resilience in facing ongoing challenges to ensure project completion were attributes each student needed to develop overnight. The final deliverable for both students was a live online presentation to the program faculty, other students, company preceptors, and colleagues.

Results

Student 1’s project necessitated having access to a company’s proprietary databases as well as third-party databases to be able to implement the project plan. Based in Beijing, China, they were quarantined at home and therefore had no access to the company databases needed for the project, as the Chinese government had imposed stringent lockdown rules.

This capstone project ran at the onset of the pandemic, from January to April of 2020. During this time, Student 1 was faced with not only mitigating the constraints related to accessing databases, but also constraints at home which included homeschooling children, caring for an elder, and having limited access to food and other necessities. By the time the project was completed, it was April 2020 followed by a virtual graduation in May 2020.

Table of Constraints—Student 1

Objective	Constraint (Risk)	Impact	Mitigation (Contingency)
Objective 1: Creation of mapping tool for real-word databases in China	Poor accessibility of the information from the databases in China.	High	1. Obtain the preceptor’s help by using company resources to gain more information. 2. Avoid using databases with limited information.
Objective 2: Creation of a checklist of data-cleaning rules/points for an RWE database	1. Timeline may change for the project depending on the RWE team’s planning for 2020. 2. Large amount of data and nonstandardized variables of the database will increase the workload.	Medium	1. Closely follow up with mentor and preceptor for adjustments to be made in terms of choice of databases to be evaluated and/or adjustments to projected outcomes from the project. 2. Closely check project plan timelines and deliverables. 3. Gather information related to RWE databases, identify barriers to access/develop processes to support a better structured database to house relevant information for the project.
Objective 3: Align with the RWE team	1. Due to the outbreak of COVID-19 in China, travel restrictions and strict quarantine rules delayed the start of the project. 2. Project shifted from onsite to remote from home due to the severe restrictions posed by the COVID-19 outbreak. This may prevent the student from participating in meetings and activities with the RWE team in terms of generating materials and access to databases needed for the project. 3. Student needs to continue to work fulltime, manage family duties, and deal with other personal responsibilities under strict quarantine rules.	High	1. Schedule online meeting with preceptor and advisor earlier while closely monitoring status of the COVID-19 outbreak. 2. Plan with the student’s direct supervisor and apply flexible working hours to accommodate time for project execution remotely. 3. Closely monitor project timelines, along with current regular workload deliverables while keeping a flexible schedule to accommodate duties at home.

Student 2 had been working as a medical science liaison and subsequently took on a leadership role within the Medical Affairs team of a global rare-disease biotechnology company in the U.S. For a rare disease company, the risks are greater with the burden of delivery resting mostly on the shoulders of medical science liaisons.

Student 2’s project was conceived at the height of the COVID-19 pandemic{6} in the U.S. and they had no option but to push through with a capstone project, as it was the only course left required for completion to graduate. Due to a complete lockdown, Student 2 had to find alternative ways of interacting with needed stakeholders for the project; their team became compromised with the unfortunate loss of personnel due to company cost cutting. Further, Student 2 had to take on more responsibilities while implementing the tasks needed to complete the project.

One-on-one engagement with the company stakeholders and access to confidential documents while maintaining strict privacy rules—as per the company’s standard operating procedures (SOPs)—were needed to assess the impact of COVID-19 on the function of medical science liaisons. Identification of potential risks to any proposed changes in the process of engagement with physicians and healthcare providers had to be incorporated into the execution of the capstone project plan.

Table of Constraints—Student 2

Objective	Constraint (Risk)	Impact	Mitigation (Contingency)
Objective 1: Assess pre-, current, and future COVID-19 impact to the  Medical Affairs industry{7}	Limited and/or no literature to address capstone objective.	High	Will seek to conduct survey with small sample size to consenting physicians with whom the student has a working relationship. Survey limitations: small sample size, limited reach of different clinician disciplines, and time.
Objective 2: Redefine Medical Affairs field role and metrics	Lack of published competitive data for physician engagement benchmarking.	Medium	Will explore other data sources for this information with preceptor and course advisor.
Objective 3: Design an innovative engagement proof of concept	1. Company may not have the internal assets to accommodate engagement concept and mobilization. 2. Proposal review/scheduled     meeting/approval of concept 3. Mobilization of proof of concept	Medium     High	Summarize the resources needed and associated cost benefit analysis to acquire needed assets (tools, capabilities, platforms). Present plan and mobilization plan in final capstone presentation and events that delayed milestones.

The assigned faculty content advisor and company preceptors provided guidance. They mentored both students through the implementation of their projects while themselves being quarantined. The detailed project plan, along with the tables of constraints, provided the best structure for each student to perform successfully (see Table of Constraints—Student 1 and Table of Constraints—Student 2).

Bi-weekly meetings were alternately set between each student, their preceptor, and the faculty content advisor. During these video meetings, discussions revolved around the project status, including identified constraints and how they were managed. It afforded a platform for the student to report on their progress with project deliverables, as well as to share insights regarding their physical well-being and mental health.

The establishment of a secure environment for honest exchange became a catalyst for the students to persevere despite the limitations posed by the pandemic. The situation also subjected their resilience to a rigid test of wits that drove them to become more creative and nimbler in gathering the information they needed to fulfill their deliverables, despite revised company security and privacy SOPs. While both expressed a form of “videoconference fatigue,” having the ability to speak with someone via a virtual platform where they heard another person experiencing similar constraints provided the much-needed balance each student sought as a means to detach from “lockdown fatigue.”

Both students experienced considerable amounts of stress which impacted their mental health.{8} During weekly video conferences, both students candidly included in their discussions details of how they worked on project activities and simultaneously dealt with the accompanying challenges that impacted their thought processes and sleep and eating habits. They soon realized the need to become more astute at devising ways to cope with multitasking between being a parent, spouse, employee, and student. Both noted how they started using the quiet times in the late evening, when everyone else in their household was asleep, to focus on their schoolwork and decompress from the daily grind.

Ultimately, Student 1 and Student 2 completed each of their capstone projects despite much trepidation. Each one delivered well-conceived presentations that garnered high approvals from preceptors, advisors, the capstone director, and the program director.

Discussion

Both students were able to successfully complete their capstone projects because of their well-developed project plans. The plans each consisted of a rationale, objectives, timeline and deliverables, and risk mitigation. Along with their plan, each student was provided a preceptor and a faculty content advisor. The integration of the preceptor and content advisor for the provision of real-time guidance played a significant role in the success of the capstone project during the unprecedented circumstances brought about by the COVID-19 pandemic.

To successfully navigate a capstone project in conditions ranging anywhere from stable to disruptive, students need to embrace the combination of their plans with their connections to committed and engaged preceptors and advisors. This combination enabled the plan to serve as a living document that was flexible enough to align with whatever tools and services were available to the student. This process resulted in meeting the requirements of JTF Competency Domains 7 (Leadership and Professionalism) and 8 (Communication and Teamwork), and added to the overall desired outcome of the MS Clinical Research Management program.

The communication process kept all stakeholders resilient and focused on the team’s efforts. Engagement among the stakeholders that was frank, open, and reassuring kept each capstone project viable. Despite the potential for negative effects to students’ mental health due to anxiety and stress levels compromised by the uncertainty of the pandemic, it was the realization of the project’s completion that became the light at the end of the tunnel.

References

1. Begg MD, Bennett LM, Cicutto L, et al. 2015. Graduate Education for the Future: New Models and Methods for the Clinical and Translational Workforce. Clin Transl Sci 8(6):787–92. doi:10.1111/cts.12359
2. Custis LM, Hawkins SY, Thomason TR. 2017. An innovative capstone health care informatics clinical residency: Interprofessional team collaboration. Health Informatics J 23(1):69–79. doi:10.1177/1460458215627188
3. Sonstein SA, Jones CT. 2018. Joint task force for clinical trial competency and clinical research professional workforce development. Front Pharmacol 9(OCT). doi:10.3389/fphar.2018.01148
4. Domains and Leveled Core Competencies—Joint Task Force for Clinical Trial Competency. https://mrctcenter.org/clinical-trial-competency/framework/domains/
5. Rajadhyaksha VD. 2020. Medical affairs post-COVID 19: Are we ready to take the baton? Perspect Clin Res 11(3):124. doi:10.4103/PICR.PICR_164_20
6. Mitchell EJ, Ahmed K, Breeman S, et al. 2020. It is unprecedented: Trial management during the COVID-19 pandemic and beyond. Trials 21(1). doi:10.1186/s13063-020-04711-6
7. Reimagining Scientific Engagements During COVID-19. Medical Affairs Professional Society. https://medicalaffairs.org/reimagining-scientific-engagements-during-covid-19/
8. Mental Health and Coping During COVID-19. Centers for Disease Control. https://blogs.cdc.gov/niosh-science-blog/2020/06/12/covid-19-stress/

Nadina C. Jose, MD, (ncj26@rutgers.edu) is an Assistant Professor in the MS Clinical Research Management program, Rutgers BioPharma Educational Initiative, School of Health Professions, at Rutgers, The State University of New Jersey.

Doreen Waldron Lechner, PhD, is an Assistant Professor and Program Director in the MS Clinical Research Management program at Rutgers.

Barbara Tafuto, MLS, PhD, is an Assistant Professor in the MS Clinical Research Management program at Rutgers.

Lisa Palladino Kim, MS, is a Lecturer and Capstone Director in the MS Clinical Research Management program at Rutgers.