Human-Centered Design for Clinical Trial Improvement: A Step-by-Step Guide with an Off-Label Drug Case Study (Preprint)

Abstract

Utilizing a human-centered design (HCD) approach and methods can provide clinical trial design teams with a better understanding of 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 off label drugs (OLD) to treat unmet clinical needs in cancer treatment. However, the HCD approach and methods are not commonly taught in the context of clinical trial design and few step-by-step guides like this study are available to demonstrate its application.

The aim of this study is to demonstrate the feasibility and process of applying a human-centered design approach to creating clinical trial support resources for physician stakeholders to overcome barriers to pursing clinical trials for off label drugs to treat cancer.

A human-centered design approach was used to develop OLD clinical trial support concepts. Semi-structured interviews were conducted with 15 physicians to identify barriers to prescribing OLDs for cancer treatments (outside of a clinical trial and absent national guidelines) and initiating cancer clinical trials for OLDs. Affinity mapping and thematic analysis of qualitative data gathered from the interviews informed further co-design exercises with 9 participants in 3 sessions. These in-person sessions included creative matrix exercises and concept voting to refine and prioritize the ideas that the design team used to produce 3 recommended concepts.

Findings demonstrate the potential of HCD methods to uncover important insights into barriers physicians face in prescribing OLDs and initiating and completing OLD clinical trials such as recruitment, financial disincentives, and stigma. Participants found the HCD approach engaging and 60% participated for the duration of the study despite their full clinical schedules. Over 150 ideas were generated in 3 co-design sessions, with the groups voting on 15 priority ideas which the design team then refined into 3 final recommendations.

Using participatory human-centered design methods, we delivered 3 concepts for clinical trial support resources to help physician stakeholders overcome barriers to pursing clinical trials for off label drugs to treat cancer. This paper highlights the process, methods, and potential of human-centered design to improve cancer clinical trial design. Future work is needed to train clinical trial designers in the HCD approach and methods, and to encourage adoption in the field.