The purpose of this research is to explore how the application of specific design thinking techniques (henceforth referred to as DT4CT) impacts the performance of a clinical trial. (For the sake of this study, performance refers to improvements in patient recruitment and/or patient retention into clinical trials; the identification of new/revised clinical trial endpoints; the identification of protocol amendments as a result of patient input to the clinical trial design. If improvements are determined then inferences may be drawn in relation to impact on clinical trial timeline and/or costs).
Clinical trial performance is an area of high interest due to the challenges faced by pharmaceutical companies in this area. Sablinski even argues that the situation is so critical that “inaction threatens the future of the entire clinical research enterprise and thus human health” (Sabliniski, 2014, p.1).
The case studies used in this research are from two large mature pharmaceutical companies and one smaller drug development company who are using design thinking techniques to improve clinical trial performance.
From a comparative analysis made of these cases we established that the applica-tion of the DT4CT process elicited notable improvements in clinical trial performance.
The limitations of this study arise from the size of the data set and the study duration. Also it would have been better for the study to be carried out by more than one researcher to bring greater validity to data coding and results.
Managerial implications from this study are as follows –
1. Overcome the challenges of recruiting patients into trial designs by using employee databases as an easy and less time consuming source of potential patients.
2. To influence and accelerate adoption of DT4CT –
a. Integrate DT4CT training into clinical trial team onboarding programs,
b. Develop and implement a change management program,
c. Insert goals related to the DT4CT process and patient partnership into annual performance plans.
3. Ensure there is enough time assigned to study teams for them to execute all three phases of DT4CT systematically.
4. As part of the protocol approval process managers should request evidence that DT4CT has been used to solicit input from patients. If the evidence is not available then the protocol should not be approved.
5. Managers should measure the impact of DT4CT on trial performance and then publish and promote positive results.
6. Consider ways to influence (incl. financing) the introduction of human cen-tered design processes such as DT4CT into education programs for statisti-cians and scientists as these are the group most likely to resist the introduc-tion of design-related processes into their number centric environment.
7. Consider how to use technology in partnership with DT4CT to make its appli-cation easier and faster.
8. Consider the important roles of managers in DT4CT. These roles are synop-sized in Table 18.0 (p.146). Through this study I am seeking to join the academic discussion on design thinking potential and process (Brenner et. al (2016)) and on pharmaceutical industry drug development models (Duyk(2003) and Sablinski(2014)) for which there is a dearth of information in the literature.
The results of this study authenticate design thinking potential in clinical trials. The study also establishes that the application of the DT4CT process will improve clinical trial performance. So the results from this study are a valuable contribution to domains (DT potential and process) for which there is a shortage of validated data.
The impact of DT4CT on clinical trial performance is also a valuable contribution to the academic discussion on pharmaceutical industry drug develop-ment models for which there is also a shortage of information and real-life data. Keywords: design thinking; empathy; co-creation; prototyping