What Biology Can Teach Us about Patient-Centric Research
In developmental biology, scientists attempt to understand how a single cell or small group of cells develop into organisms. Cells within a living body (with a few exceptions) have the same DNA, so why are neurons so different from skin cells? The answer lies in how the DNA is regulated to express certain proteins and not others. To understand how DNA is regulated during the development of an organism, development biologists try to define what is necessary and what is sufficient.
The concept of necessity is a factor that is required to express certain DNA. But being necessary (needed) is not the same as being able to cause a change in DNA expression by itself. The concept of sufficiency is that a given factor, or group of factors, together will drive a specific outcome.
So, what on earth does biology have to do with patient-centric clinical research?
My background in developmental neurobiology makes me quick to notice systems of necessity and sufficiency. The push to make clinical trials more patient-centric from regulatory bodies and innovative organizations has led to many claims: "Listen to patients," "leverage decentralization," "engage more ethnically diverse Principal Investigators to access ethnically diverse participants." Each of these claims have merit, yet for all the patient panels convened, patient-centric consultants hired, and internal initiatives launched, data has yet to fully realize meaningful shifts in the accessibility of clinical trials to most folks.
I’d like to suggest that is because even the most valuable initiatives, while necessary, are rarely sufficient to create patient-centric clinical trials. Yes, you should look for regions and sites with access to ethnically diverse patients. Yes, you absolutely should listen to participants and their needs in shaping how you define clinically meaningful outcomes. And certainly, leveraging technology to make studies more modern and accessible is a no-brainer. Each of these steps are necessary - if you don’t do them, your study will likely fail the ‘patient-centric test’.
To achieve patient-centricity in your clinical trial, you’ll want to first identify any missing necessary factors. Three major areas of patient-centricity to consider are:
- Develop your endpoints strategies around both research outcomes and your patients’ experience.
- Listen to what matters most to your patients and design the study operations with their lifestyle in mind.
- Select a technology platform that offers the easiest and most comprehensive solutions to reduce burden and drive engagement.
But the question remains, are these necessary steps really enabling patient-centricity? In clinical research, as in developmental biology, sufficiency is often a collective outcome, not the result of an individual factor. Understanding this is critical. To put it another way, it is often the mix of multiple necessary factors that, when used together, that drive a specific DNA expression at a given time in development.
Similarly, in many clinical trials, it is putting together multiple components of trial design, technological support, and practical application in the real world that draws in participants and keeps them engaged throughout the study. Learn more about how THREAD can support your patient-centric study by visiting THREADresearch.com
With so many companies promising solutions to drive inclusion, speed, and efficiency, why does the data indicate trials are getting longer, slower, and more expensive? To achieve your study’s objectives, you may need to think about decreasing friction. More on that next time...