Allowing Patients to Use Their Own Words Generates Better Clinical Trial Insights, Study Finds

March 13, 2019

A patient-centric approach to clinical trials doesn’t just improve participation – but may also lead to more valuable medical insights.

Could open-ended questions on patient surveys actually yield better clinical trial results? A recent study from the University of North Carolina Lineberger Comprehensive Cancer Center attempts to answer this crucial question.

By comparing typical survey methodologies with a more patient-centric approach, researchers found there were indeed differences. In fact, there were significant advantages to giving patients the opportunity to use their own words. This suggests that a patient-first perspective isn’t just crucial for attracting and keeping trial participants – it can also elicit more detailed and insightful responses from patients.

The Patient Response Study

Published in the Journal of the American Medical Informatics Association, this unique study focused on two methods for collecting patient information, surveying 1,760 patients in three major cancer clinical trials. In this scenario, patients could either choose to describe their symptoms by choosing from a predetermined set of medical terms (which is how most clinical trials collect patient data), or by detailing their symptoms in their own words.

In this study, patients were given free rein to choose and describe their symptoms, which revealed additional issues and symptoms that would otherwise have gone unmentioned. Patients typically provided more than two entries, and 58% entered additional symptom information. Researchers manually cross-referenced the free-text entries with standard medical terms, although more efficient machine-learning tools could be designed and implemented for future use.

In response to these results, the study’s lead author, UNC’s Arlene Chung, MD, MHA, MMCi, and Associate Director of Health and Clinical Informatics, suggested the standard approach “may not be sufficient to capture what patients are experiencing during cancer treatments.” With this kind of free-text approach, researchers could better identify possible symptomatic adverse events. And down the line, doctors could more accurately counsel patients on what to expect from treatments.

Taking a Patient-Centric Approach

There are many reasons to take a patient-centric approach when it comes to clinical trials. With some 85% of clinical trials failing to recruit enough participants, patient recruitment is a recurring challenge. But patient-conscious questionnaires can help turn the right leads into actual participants. A more personalized approach at the beginning, including consistent digital communication, can also go a long way in encouraging patients to enroll.

Maintaining continuous participation is crucial, too, as 30% of patients drop out of studies after entering. Taking a patient-centric perspective during the study often means considering barriers to participation, such as getting to and from the investigator site. To minimize these obstacles, trials could provide transportation through partnerships with Lyft and Uber. In other cases, they could implement sensors and wearables that automatically provide individual insights, without additional effort from patients. Taking this UNC study as a cue, researchers may also want to consider an open-ended questionnaire when polling patients about barriers to participation.

Ensuring continued trial participation is, of course, key. But as this study shows, a patient-centric approach does more than get people in the door. It can actually make a difference in collecting valuable information from trial participants. It’s crucial to design studies not just to ensure client participation, but to learn as much as possible, even with limited time and budget. This strategy is better for your trial, and ultimately better for patients, including future patients who will benefit from these insights.

Making patient-centric changes to clinical trials doesn’t have to be complicated. Implementing open-end questions is a simple yet effective way to think differently about patient insights – and let participants know how much their input is valued.