Putting the patient at the center of COA development
“Patient-centricity” is a hot topic within life sciences, and clinical trial sponsors are increasingly cognizant of designing trials that yield a positive, inclusive experience for patients. In any trial, patients, sponsors, and clinicians all ultimately want the same thing: an efficient, well-designed experience that leads to the development of safe, effective, and life-improving medications and devices.
In practice, however, details get in the way—and there can be a disconnect between what matters to patients and what matters to clinicians. When trials and their components are designed without patient input, the result can be unsatisfied patients and unclear results—which are not the outcomes anyone wants.
What matters to patients in a clinical trial
Patients involved in clinical trials care deeply about their health, safety, and ability to preserve their lifestyle. Patients who participate in a clinical trial care about the trial’s impact on their quality of life. They care about any side effects that may arise from the therapy prescribed. They care about the convenience of the trial: whether they can easily access the trial site, whether their clinical staff is accessible, and whether the amount of time required to participate in the trial is reasonable. They care about the burdens—including paperwork and other non-medical tasks—placed upon them throughout the course of the trial. And they care about feeling understood, educated, included, and empowered.
What matters to clinicians in a clinical trial
The qualities of a clinical trial that matter most to patients may not top the list of clinicians’ priorities. Clinicians involved in clinical trials care most about the quality of the data they collect and its ability to help them meet their primary endpoints. That means that qualities like patient compliance, data accuracy, and volume of participation matter most. Sometimes, these clinical priorities can clash with patients’ inherently human requirements.
How to bridge the gap
One way to narrow the divide between patient and clinician priorities during a clinical trial is to prioritize the patient voice in the COA instrument or platform design process at all relevant points. There are a variety of approaches to user testing which can improve accessibility for different demographic groups. These include:
- Linguistic validation to ensure cultural validity, accuracy and appropriateness of COA translations, all of which can impact the psychometric properties of an instrument.
- Readability testing and face validation to ensure comprehensibility and proper function of COAs as written in their source language for specific populations.
- Usability testing to improve the patient experience of responding to COAs in specific modalities (e.g., eCOA) and the quality of the data they collect.
- Equivalence testing to ensure that data collected by COAs across modalities, culture or time is comparable.
Initial and continued assessment of core outcome sets is another component of prioritizing the patient in clinical trials research, as patients’ priorities and needs for reporting their symptom experience or assessing treatments may shift unpredictably across cultures, countries or time. By collecting feedback directly from patients from different linguistic, cultural, geographical, and socioeconomic backgrounds, the linguistic validation process offers an ongoing opportunity to assess and update COAs so they maintain the ability to collect clinically useful data that accurately reflects the patient experience.
All of these approaches can be deployed within the development process, at various points, to maximize representation of the patient voice, and ideally can be applied as COAs age and are extended to new populations and contexts.
Interested in learning more about keeping patients at the center of COA development? Reach out to our team today.