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Original Paper

Engaging Cancer Care Physicians in Off-Label Drug Clinical Trials:
Human-Centered Design Approach
Maren C Parsell1,2, MBA; Morgan N Greenleaf1,2,3, MS; Greeshma G Kombara2,4, MPH; Vikas P Sukhatme2,4,5, MD,
SCD; Wilbur A Lam1,2,3,6, MD, PhD
1Georgia Clinical and Translational Science Alliance, Emory University School of Medicine, Emory University, Atlanta, GA, United States

2

Emory School of Medicine, Emory University, Atlanta, GA, United States

3

Center for the Advancement of Diagnostics for a Just Society (ADJUST), Emory University, Atlanta, GA, United States

4

The Morningside Center for Innovative and Affordable Medicine, Emory University School of Medicine, Emory University, Atlanta, GA, UnitedStates5

Departments of Medicine and Hematology and Medical Oncology, Emory University, Atlanta, GA, United States

6

Aflac Cancer and Blood Disorders Center of Children’s Healthcare of Atlanta and Department of Pediatrics, Emory University, Atlanta, GA, UnitedStatesCorresponding Author:
Maren C Parsell, MBA
Georgia Clinical and Translational Science Alliance
Emory University School of Medicine
Emory University
1440 Clifton Road
Atlanta, GA, 30322
United States
Phone: 1 4048896149
Email: maren.parsell@emory.edu

Abstract
Background: Using a human-centered design (HCD) approach can provide clinical trial design teams with a better understandingof the needs, preferences, and attitudes of clinical trial stakeholders. It can also be used to understand the challenges and barriers
physician stakeholders face in initiating and completing clinical trials, especially for using off-label drugs (OLDs) to treat unmet
clinical needs in cancer treatment. However, the HCD approach is not commonly taught in the context of clinical trial design,and few step-by-step guides similar to this study are available to demonstrate its application.
Objective: This study aims to demonstrate the feasibility and process of applying an HCD approach to creating clinical trial
support resources for physician stakeholders to overcome barriers to pursuing clinical trials for OLDs to treat cancer.
Methods: An HCD approach was used to develop OLD clinical trial support concepts. In total, 45 cancer care physicians were
contacted, of which 15 participated in semistructured interviews to identify barriers to prescribing OLDs or participating in cancer
OLD clinical trials. Design research is qualitative—it seeks to answer “why” and “how” questions; thus, a sample size of 15 was
sufficient to provide insight saturation to address the design problem. The team used affinity mapping and thematic analysis ofqualitative data gathered from the interviews to inform subsequent web-based co-design sessions, which included creative matrix
exercises and voting to refine and prioritize the ideas used in the final 3 recommended concepts.
Results: The findings demonstrate the potential of HCD methods to uncover important insights into the barriers physicians facein participating in OLD clinical trials or prescribing OLDs, such as recruitment challenges, low willingness to prescribe withoutclinical data, and stigma. Notably, only palliative care participants self-identified as “frequent prescribers” of OLDs, despite highnational OLD prescription rates among patients with cancer. Participants found the HCD approach engaging, with 60% (9/15)
completing this study; scheduling conflicts caused most of the dropouts. Over 150 ideas were generated in 3 co-design sessions,with the groups voting on 15 priority ideas that the design team then refined into 3 final recommendations, especially focused onincreasing the participation of physicians in OLD clinical trials.
Conclusions: Using participatory HCD methods, we delivered 3 concepts for clinical trial support resources to help physician
stakeholders overcome barriers to pursuing clinical trials for OLDs to treat cancer. Overall, integrating the HCD approach can
aid in identifying important stakeholders, such as prescribing physicians; facilitating their engagement; and incorporating theirhttps://formative.jmir.org/2024/1/e51604

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perspectives and needs into the solution design process. This paper highlights the process, methods, and potential of HCD to
improve cancer clinical trial design. Future work is needed to train clinical trial designers in the HCD approach and encourage
adoption in the field.
(JMIR Form Res 2024;8:e51604) doi: 10.2196/51604
KEYWORDS
human-centered design; clinical trial design; design methods; clinical trial; trial methodology; barriers; off-label drugs; stakeholders;
cancer; medications

Introduction
Project Goals
Cancer clinical trials involve the coordination of many
stakeholders but frequently fail to meet enrollment goals,
prespecified end points, and timelines [1,2]. Effective
stakeholder engagement can be essential to cancer clinical trial
design, conduct, and reporting of clinical research [3]. However,traditional design approaches often lack consideration of
stakeholders’ needs, preferences, and experiences, which canlead to recruitment and retention challenges or to study resultsthat are less generalizable or applicable to real-world settings.
Trial stakeholders include physicians who face unique barriers,
especially when designing trials for off-label drugs (OLDs) totreat unmet clinical needs in cancer treatment [4]. Assumptions
that stakeholders will be willing to participate in a trial may notadequately factor in the unique challenges and barriers thatpatients with cancer and stakeholders face. In addition,
underrepresented and marginalized populations’ needs can also
be missed because their perspective is rarely represented byclinical trial designers, which can lead to a lack of diversity inclinical trial participants and potential disparities in treatment
outcomes [1].
To overcome these limitations, a human-centered design (HCD)
approach offers both a process to learn about the needs of thetrial stakeholders as well as flexible tools to test assumptions,uncover barriers, and work collaboratively with study
stakeholders to optimize the clinical trial design. An emerging
body of literature on HCD for health care innovation yields
many HCD methods to choose from [5], making it difficult for
novice innovators to know where to start and which methods
to use. The purpose of this paper is to demonstrate HCD
methods through a case study, where cancer care physiciansparticipated in developing solutions that reduced barriers
associated with initiating clinical trials for promising OLDs.

Background
HCD is a problem-solving methodology that focuses on
discovering needs and developing solutions for individuals
within a system; it is increasingly being used in cancer caresettings [6-8]. HCD is particularly well-suited for uncovering
and understanding the complex attitudes and barriers
contributing to physician off-label prescribing behavior for avariety of Food and Drug Administration–approved drugs withstrong safety profiles such as aspirin that may have anticancer
properties [9]. These medications have shown early evidence
when prescribed off-label, in reducing the risk of developing

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certain types of cancer such as colorectal cancer, or in improving
patient outcomes. However, due to low financial incentives andresources, and the lack of further clinical testing to provide
definitive prospective data, physician awareness is low, andprescription adoption has been minimal [10]. To help build
incentives and engage physicians to consider repurposed OLD
options, the Morningside Center for Innovative and Affordable
Medicine (Morningside Center) [11] based at Emory University
worked with staff trained in HCD methods from the Innovation
Catalyst program within the Georgia Clinical and Translational
Science Alliance (CTSA) [12]. The Georgia CTSA team set
out to first learn more about the barriers to these types ofprescriptions and then work together with physicians to propose
support programs to increase the consideration of repurposed
OLD treatment options for their patients. We explored theimplications of these findings for physician receptiveness to
conducting clinical trials with repurposed OLDs.

Methods
Study Design
HCD is an iterative and flexible process for generating solutions
to problems that typically includes 3 phases: learning about thehumans involved in the situation, coming up with and refining
concepts, and implementation. Additional steps can be added
to address the specific needs of the project, and the CTSA
research team emphasized stakeholder analysis because many
stakeholders influence prescription decisions, so understanding
who had the greatest influence was important to forming theguiding questions for the ideation activity. Thus, the teamfollowed four steps with each step matched with an appropriate
HCD method: (1) collect, sort, and analyze insights using
semistructured interviews and affinity mapping; (2) identify
influences using a stakeholder power-interest grid; (3) generate
and prioritize ideas using a co-design activity called a “creative
matrix” [13]; and (4) produce concepts to prototype by refining
and ranking ideas generated from the co-design activity (Figure1). The team identified 45 physicians who met the cancer careinclusion criteria within the Emory academic medical centerecosystem or community practice setting. From this pool, 15
agreed to participate in semistructured interviews. Of the 15
physicians interviewed, 8 were oncologists, 3 were palliative
care specialists, 2 were urologists, 1 was an anesthesiologist,and 1 was a family medicine physician (Multimedia Appendix
1). Although this sample size is small, it was adequate to achieve
insight saturation, or the point where participants were providing
similarly themed insights.

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Figure 1. Illustration of human-centered design process and methods used in this study.

Collect Insights
Within the HCD approach, qualitative research methods suchas interviews, focus groups, or ethnography are typically used
to gain insights about the situation, influencing factors, as wellas the needs and wants of the stakeholders involved. The
Georgia CTSA research team conducted semistructured
interviews, which involve asking open-ended questions thatallow for more free-flowing conversation than in structured
interviews. A set of predetermined questions or topics guided
the conversation, but there was also flexibility to follow-up on
interesting or unexpected responses and to explore topics inmore detail. Some of the key questions the team sought toanswer were:https://formative.jmir.org/2024/1/e51604

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Have you prescribed OLDs? Why or why not?
What level of information or data do you need to prescribe?
Where do you find information on OLDs?
Who influences your OLD prescription decisions?
What influences your decision to participate in OLD clinical
trials?

The interviews produced dozens of pages of transcribed data,
which the team reduced to key points on Post-it notes in
preparation for a thematic analysis process called affinity
mapping. Concepts that are related to each other were grouped,
and a theme was coded for each group (Figure 2). In addition,
stakeholders who influenced prescription decisions were also
noted.

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Figure 2. Screenshot of affinity mapping method used for sorting insights in this study. Mgmnt: management; OLD: off-label drug; Rx: doctor'sprescription.

Identify Influencers
To validate assumptions about who ultimately makes OLD
prescribing decisions and to verify decision-making impact, theGeorgia CTSA research team identified stakeholders based on
the insights collected from the interviews and affinity mapping
process (Multimedia Appendix 2). This list of stakeholders washttps://formative.jmir.org/2024/1/e51604

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then mapped to a power-interest grid, which involves plotting
stakeholders on a 3D grid based on their level of power or
influence over the situation and their level of interest in
outcomes (Figure 3). Stakeholders with high levels of powerand high levels of interest are considered key players and require
the most engagement while high-interest and lower-powerstakeholders should be kept updated.

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Figure 3. Screenshot of power-interest grid method used for stakeholder analysis in this study. FDA: Food and Drug Administration; IRB: institutional
review board; MD: Doctor of Medicine; mgmt: management; OLD: off-label drug; PCP: phencyclidine; PI: principal investigator.

Generate Ideas
Co-design activities include the end users of a solution in theideation of that solution. Co-design is an effective way toincrease stakeholder engagement, which is essential to projectsuccess, particularly in cancer care delivery research [3]. There
are many methods to collaboratively come up with ideas, suchas rapid ideation, brainwriting, mind mapping, thumbnail
sketching, and many others. Which method to select depends
on the goals of the session, the time allotted, and who isparticipating. The Georgia CTSA team selected the creative
matrix method (Figure 4), which concentrates ideation on a

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particular topic using a visual grid with 2 questions and up to
4 categories. This method can generate a high volume of ideas
in a short time and within a specific context. The research teamselected salient topics that arose from the affinity mapping
exercise to create the context for 2 creative matrix exercises
used in three 1-hour co-design sessions with 9 physicians.
Participants were allotted 6 minutes to generate ideas and 3
minutes to select 2 concepts that they believed had the mostvaluable to help support the consideration of repurposed OLDs
for prescription. These “best ideas” were subsequently mappedon a grid for impact versus effort to identify which ideas would
have the most impact and lowest effort.

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Figure 4. Screenshot of creative matrix method of guided ideation used in this study. AI: artificial intelligence; AMC: academic medical center; EMR:
electronic medical record; FDA: Food and Drug Administration; OLD: off-label drug; WG: working group.

Vote and Produce Prototypes
Involving co-design participants in the idea evaluation process
is important for getting feedback on the feasibility, desirability,and viability of the ideas [14]. It can increase participants’ senseof ownership and investment in the final solution, potentiallyleading to greater adoption and success. While co-design
sessions can generate a high volume of ideas quickly, further
refinement to create workable prototypes for testing issometimes necessary, and this study’s team distilled concepts
that were well-received by physicians during the co-design
sessions into 3 prototype-ready directions.

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Ethical Considerations
This study was reviewed by an ethics committee to ensure theprotection of research participants, and it was approved by
Emory
University
Institutional
Review
Board(STUDY00004025). Each participant provided consent to beinterviewed and that their responses could be used in our design
study without additional consent. The privacy and confidentialityof participants and their responses were ensured by removing
names and any other fact that might point to participants’
identity in this study; also, research records are kept private to
the extent required by law. The compensation for participationin this study was a US $50 gift card.

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Results
Thematic Analysis
Of the 45 physicians we contacted, 15 agreed to be interviewed
and share their experiences and opinions on OLD prescribing
for cancer care. Key themes that emerged from the interviews
showed that, in contrast to documented high off-labelprescription rates in cancer [15-17], the interviewed physicians
were less likely to self-identify as “frequent prescribers,” citinga range of barriers. A lack of clinical trial evidence to support
the prescription was most frequently expressed as a barrier toprescription, as well as cost and reimbursement concerns andthe lack of knowledge of off-label options. A notable exception
to off-label prescription hesitancy was seen in palliative carespecialists who expressed few barriers to prescribing off-label
but emphasized that their focus was on easing symptoms andnot providing treatment. To learn about OLDs, physicians
described a variety of sources but most often relied on
professional social networks to discover and deepen knowledge;
however, they struggled to find information on specific OLDs
when they needed it.
On the power-influence grid, cancer care physicians wereidentified as the stakeholders having the highest power andinterest in patient prescriptions, validating the assumption that

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they are the primary prescription decision makers who require
the most engagement. Patients and their families were mapped
to the high-interest but less power quadrant and were sometimes
the source of OLD prescription requests that did not always
lead to prescriptions.

Concept Generation
The Georgia CTSA research team synthesized insights fromthe interviews into 2 brainstorming themes used during 3
co-design sessions with 9 physician participants. The firstcontext explored types of support needed for physicians to
consider OLDs as concurrent treatment, which generated 70
concepts. The second context focused on what support wasneeded to make it easier to start and complete an OLD clinical
trial, which produced 95 concepts. Of the 165 total concepts,
participants voted for 14 of the ideas that they felt best supported
their needs, which the physicians mapped to identify whichwere high impact or lower effort. The selected concepts included
providing dedicated clinical research coordinators, protected
time for clinical trials, electronic medical record prompts orreminders, incentive programs, an OLD reference database orapp, and endorsements for OLD trials at team meetings to
support recruiting efforts (Multimedia Appendix 3).
The research team further synthesized these concepts into 3
prototype-ready directions listed in Textbox 1.

Textbox 1. Recommended concepts delivered to the Morningside Center after this study.
Concept and description•

Off-label drug (OLD) fellowship program••

OLD clinical trial support package••

An invitation-only program for physicians initiating OLD clinical trials that emphasizes promotional communications for the principal
investigator (PI) to promote the study and offers protected research time.

Sponsored package of select administrative resources including a clinical resource coordinator to facilitate OLD trials.

OLD searchable database•

On-demand digital tool to provide national repurposed OLD updates, identify center-wide OLD trials and PIs, and look up available clinical
trial resources.

In a web-based survey, all 15 physician participants were asked
to force rank the concepts that they felt was the most impactful
to supporting repurposed OLD prescription decisions; we
received 7 responses (Multimedia Appendix 4). The fellowship
program concept surfaced as the leading idea with a mean of

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2.0 (SD 0.93; Figure 5). Overall, concepts that resonated mosteither supported clinical trial development or bolstered social
interfaces from which they could learn about OLDs from otherphysicians.

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Figure 5. Force ranked physician votes for 3 prototype-ready concepts to support repurposed OLD prescription decisions. OLD: off-label drug.

Discussion
Principal Findings
Using this case study, we have demonstrated the flexible natureof HCD as it relates to accommodating unique characteristicsof the project, selecting from a wide range of ideation
techniques, and adapting to participant ideas and preferences.
The findings also demonstrate the potential of HCD methods
to uncover important insights into physician decision-making
processes that can lead to improving OLD prescription andclinical trial practices. Clinical trial designers can similarly use
these methods to gain a deeper understanding of the target
audience’s needs, preferences, and attitudes toward a potential
trial. Insights can help overcome barriers to participation, suchas language or cultural differences, and inform more effective
trial protocols that lead to greater participant engagement andretention. Without using the grounded approach of first
synthesizing stakeholder insights, ideation sessions may not be
as productive.
A notable feature of HCD is high engagement among
participants, also demonstrated in this study with 60% (9/15)
of physicians participating from the initial interviews to theideation and final voting exercises. Further, 1 participant said,“I really appreciate being listened to and would be willing tovolunteer to test these ideas.” HCD can be used to increase
patient engagement by incorporating the needs, preferences,
and attitudes of potential trial participants [18]. Participants
who did not participate in all activities of this study either did
not respond to the invitations or declined because of schedulingconflicts.

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HCD’s participatory nature contrasts with the traditional clinical
trial design, which often does not engage the participants forwhich the trial is designed. This can lead to important
perspectives or data being missed and result in low patientengagement and incomplete or biased research outcomes. The
high failure rate of clinical trials has led to increasing interestin using stakeholder and patient engagement to support clinical
trial design [3,19]. In the context of clinical trial design, aco-design activity could involve collaborating with patients,
health care providers, and other stakeholders to co-design trial
materials, such as patient education materials or data collection
forms to ensure that they are acceptable and feasible.
While HCD offers a flexible process and many methods tochoose from, it is very different from the linear thinking andhierarchical norms associated with traditional scientificapproaches [20], which may thwart the adoption or effective
implementation of the HCD process. Additional challenges can
include the potential for interviewer bias and the time- andresource-intensive nature of conducting interviews and co-design
workshops. While HCD is becoming an increasingly familiar
term, access to training remains low as few institutions haveinternal design teams, usually found in innovation centers [21],to consult with or to run projects. Thus, acquiring and building
HCD expertise can be expensive, and it remains to be seen how
future clinical innovation funding or such services will beallocated.

Conclusions
Although a relatively new problem-solving approach in healthcare, HCD can provide tangible, flexible, and reproducible
methods that include stakeholders in the ideation andproblem-solving process [22]. HCD can help identify and engage
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important stakeholders such as physicians and patients in thedesign process and then integrate their perspectives and needs
into the subsequent solutions, which is increasingly seen as animportant contributor to cancer clinical trial success. This casestudy provides a step-by-step guide on how to apply the HCD

Parsell et alprocess and selected methods to generate stakeholder-centeredsolutions. HCD has the potential to be an important tool toincrease success rates of clinical trials, but increased institutional
support and researcher training will be needed for HCD toprovide its fullest benefit.

Acknowledgments
This work was supported by the National Center for Advancing Translational Sciences of the National Institutes of Health(UL1TR002378) and the Emory Morningside Center for Innovative and Affordable Medicine.

Data Availability
All data generated or analyzed during this study are included in this published paper and its supplementary information files.

Conflicts of Interest
None declared.

Multimedia Appendix 1
List of physicians who participated in the study, their specialties, and co-design session attendance status.
[PDF File (Adobe PDF File), 36 KB-Multimedia Appendix 1]

Multimedia Appendix 2
Brainstorm activity to record all stakeholders who influence the prescption of off-label drugs, used as the first step in the stakeholder
mapping exercise.
[PDF File (Adobe PDF File), 243 KB-Multimedia Appendix 2]

Multimedia Appendix 3
Co-design activity concepts organized by innovation question.
[PDF File (Adobe PDF File), 277 KB-Multimedia Appendix 3]

Multimedia Appendix 4
Descriptions of prototype concepts with survey results from physician participants.
[PDF File (Adobe PDF File), 378 KB-Multimedia Appendix 4]

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Abbreviations
CTSA: Clinical and Translational Science Alliance
HCD: human-centered design
OLD: off-label drug

Edited by A Mavragani; submitted 04.08.23; peer-reviewed by E Vashishtha; comments to author 14.09.23; revised version received
20.10.23; accepted 22.11.23; published 15.02.24
Please cite as:
Parsell MC, Greenleaf MN, Kombara GG, Sukhatme VP, Lam WA
Engaging Cancer Care Physicians in Off-Label Drug Clinical Trials: Human-Centered Design Approach
JMIR Form Res 2024;8:e51604
URL: https://formative.jmir.org/2024/1/e51604
doi: 10.2196/51604
PMID: 38358789

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JMIR FORMATIVE RESEARCH

Parsell et al©Maren C Parsell, Morgan N Greenleaf, Greeshma G Kombara, Vikas P Sukhatme, Wilbur A Lam. Originally published in
JMIR Formative Research (https://formative.jmir.org), 15.02.2024. This is an open-access article distributed under the terms of
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