Patient Centricity in Clinical Trials: Where Do We Go Next?

Tom Krohn, Chief Development Officer, Antidote

Tom Krohn, Chief Development Officer, Antidote

This article is the first in a series on patient centricity in clinical trials. 

Over the last few years, clinical research organizations have piloted and explored a number of innovations in the hopes that new ideas—from wearables to social media recruitment—would improve the efficiency of conducting clinical trials. While there has been some progress and rays of hope, the clinical trial enterprise is still largely the same. It is time to embrace full patient involvement, and not just the platitudes of patient centricity.

While there are lots of opinions about, and approaches to, patient centricity, this blog begins a series of posts intended to share, from the perspective of a digital health company seeking to bring patients and researchers together, a fresh and pragmatic view on patient centricity and its implementation. We’ll look at such topics as the challenges of the current site-centric approach for enrollment, the difficulties tied to patient decision-making when considering a trial, and the importance of patients as part of the study design process.

Research remains too slow and expensive, and society’s need for research remains high. Around half of all American adults live with one or more chronic health conditions. In cancer specifically, every year 12.7 million people are diagnosed, but only a discouraging turnout of 3% of people with cancer participate in a clinical trial. For many diseases, a clinical trial should be considered as a care option—it may be a patient’s best chance, and is typically accompanied by expert care and a full workup. As Jennifer Byrne of the Greater Gift Initiative recently shared, clinical research as a care option is also good business.

How can we design trials that are the right fit for patients, and then how do we make sure patients know about those trials? Patient centricity has been an industry buzzword for a few years now, and it’s just as relevant today. The U.S. Food and Drug Administration now states that trial design, to begin with, should be driven by patients to make trials less burdensome. Patient diversity is also a priority.

Patient data can be used to create smarter trial design, along with input from patients themselves on everything from what treatments would most impact their lives, to the minutiae of how to set up the study schedule. Traditional study design often looks to data to help the design process by asking the question: “Do patients that fit this eligibility criteria exist?” While this is a good starting question, just because the data say such patients exist doesn’t mean they are willing to participate. How we view patient engagement data can have a profound impact on study design, execution, and performance.

I doubt anyone in the clinical research space would disagree that patient recruitment is another challenge area that could use a boost of innovation. To start, traditional patient recruitment is study-centric, not patient-centric. Researchers ask, “does this patient match MY study?”; however, patients are not looking for a study, they are looking for improved health through treatment options. A fresh approach can shorten recruitment timelines by connecting more patients with trial matching opportunities.

Clinical research professionals also have a significant role to play in improving the patient experience and, ultimately, the success of each trial. From initial study design all the way to interacting with patients at a site, it is critical that people who work in clinical research keep patients at the center—as their “north star.” In fact, we’ve heard from patients that their interaction with study coordinators is what drives them to continue engaging in a study. ACRP is committed to improving clinical research by offering support to clinical research professionals, and we’re glad this support includes exploring the various facets of patient centricity through this new blog series.

Author: Tom Krohn, Chief Development Officer at Antidote