Design Thinking in Clinical Research

What is Design Thinking?

Design thinking is a human-centred, innovation platform or framework. It works as a non-linear, iterative process used to understand users, challenge assumptions, redefine problems and create innovative solutions to prototype and test.

Design Thinking is extremely favourable in solving problems that are poorly defined or unknown, leading to better products, services, and internal processes.

Fig 1: 5 Phases in Design Thinking (as per Stanford d.school)

In many ways, although Design Thinking looks more like a platform for designing user experience in products, it is in fact extremely sector-agnostic. If you were to observe closely, it is perfect to apply in the field of scientific research – even more so in the field of clinical research. After all, we are never sure of what the end result of any clinical trial is going to be. It's not just about proving safety and efficacy in the trial - but more so on how we go about it. Typical of any research, even in drug development & clinical development, we start with a hypothesis and test whether to accept or reject the hypothesis.

Design Thinking in Clinical Research

Fig 2: Clinical development process

Clinical research is just one part of the entire drug development process and clinical trials make up the bulk of the clinical research part. Clinical trials are further divided into different phases, based on their objectives, design, complications, expected end results, etc.

How can Design Thinking be implemented in clinical trials?

Fig 3: Flow of events in a typical clinical trial

Design Thinking is different from DESIGNING! And phases of design thinking are tangentially different from phases of clinical trials.

But there is a great amount of design thinking that is already applicable in clinical trials. In every aspect of a clinical trial, one can turn to design thinking to address the unmet or undefined need of the trial itself.

For simpler understanding, let us just take the first problem of “Maintenance phase of a typical Clinical Trial”. The phases of design thinking can be applied thus:

1. Empathy – understanding your stakeholder

Who/which stakeholder is most impacted by the current state of the clinical trial

2. Define – understanding the question

What is the biggest roadblock this stakeholder is facing

3. Ideate – look at possible solutions

What are the possible ways the roadblock can be eliminated, in a human-centred way for the stakeholder

4. Prototyping – your idea(s) to select the best possible one

Of all the maverick ideas that the team came up with, which ideas are at least worthy of giving a shot; discuss the pros and cons for each of them and come up with one that can be taken to the next level – always keeping in mind human-centricity

5. Testing – test the prototype for viability

Test the validity of the most viable idea that the team believes most in – here too the stakeholder’s interests are to be protected

6. Launch – after seeking feedback

Based on the testing and the feedback received from the testers, seek buy-in from the stakeholder to formally launch the solution

For practical applicability, the stakeholder can be any party involved in the trial – subjects, sites/site personnel, clinical operations team, data management team, centralized monitoring team, project manager, CRO, sponsor… the list goes on. And it also applies to any specific issue in the trial – in this case, since we said we will apply design thinking during the ‘maintenance phase’ of the trial, the problem could be – poor data entry, inadequate oversight of sites, under-reporting of adverse events/serious adverse events (AE/SAEs), third-parties like labs or lab data, drug accountability, etc.

At each phase of design thinking, if you are not fully satisfied with the outcome, you can always go back to the previous phase or any of the earlier phases to come back with a better solution. Once you are satisfied with the new outcome, surge ahead.

Fig 4: One can go back to any phase during Design Thinking

Now that the solution has been successfully implemented, what next? Remember that Design Thinking is an iterative process – no solution is a final solution, but always a ‘prototype’ for the next iteration. So, apply Design Thinking human-centricity and find another problem to solve in the clinical trial…

Happy Design-Thinking!