How to Integrate Patient Voice Into Your Clinical Trial
Ensuring clinical trials are truly patient-centered is critical for the life sciences field. While the intention to incorporate patient input and feedback can be seen throughout the industry, clinical research studies often don’t rise to this challenge in practice. And that challenge is real; adopting a truly patient-centered study design means acknowledging that every patient comes in with differing backgrounds, needs and expectations. While it might not be possible for today’s clinical research studies to effectively and efficiently address each patient on an individual basis, there is ample opportunity to better incorporate patient voice throughout a trial. Sponsors and CRO’s should take the first step to identify individual needs and find a common thread that can align an entire patient group. In turn, messaging, recruitment, study design and protocol mandates can all be adjusted with the patient voice in mind and for optimal trial success.
Identify the “Who”
Identifying the need to integrate patient input into clinical research presumes a certain definition of “patient.” Of course, actual study patients, the ones receiving intervention from a device or medication, should be the primary audience with whom to engage in the study. However, caregivers and even sites should also be considered when eliciting input into and feedback on a research study. Caregivers, whether family members or paid home health providers have the ability to reduce the patient burden and maximize opportunities to stay within study protocol. In decentralized clinical trials (DCT) there is greater opportunity for these caregivers to play a critical role in wearable device use, telehealth support and other interventions that are done at a patient’s home.
Incorporate Early & Ongoing Feedback From Patients
The saying “don't ask the question if you don't want to hear the answer” aptly applies to gathering patient input for clinical trial work. Sponsors and CROs need to diligently identify areas within a study in which patient input could have an impact and only incorporate those into their feedback models. Two questions that should be at the forefront of any patient input are “what do we do with the information gathered?” and “do we have the resources (time/budget) to make the identified changes?” Talking to patient and advocacy groups early in the process can help identify key areas of interest or concern, which can then be built into timelines and budgets. This stage of input ideally includes conversations regarding if the treatment will help (i.e., will it have value to the population served) and if the identified outcome measures make sense.
Align Clinical Study Design to Patient Input
One of the benefits of running a DCT is the inherent patient-focused flexibility within the virtual study model. DCTs provide options to the patient, allowing participation via both telehealth and hybrid engagement. Sponsors and CROs can also“listen” to participant feedback through the various DCT technologies and methodologies, such as wearables and online diaries. The traditional models for listening to the patient are being disrupted with technologies that use AI and Machine learning-based approaches that yield deeper insights and more powerful analysis. For example, wearables must fit into a patient's life, not be a deterrent to trial engagement. Instead of just asking a patient if they’ll wear a device, trial administrators can uncover questions or concerns that provide opportunities to optimize the study design. In turn, patient data collected from these devices offer feedback immediately, allowing trial managers to alter appropriate study elements in real-time and make improvements systematically.
Learn more in our webinar, Integrating the Patient Voice in the Design and Execution of DCTs, featuring THREAD’s John Reites and inVibe’s Fabio Gratton.
Todd Harnett
Head of North America Delivery
A seasoned client engagement professional with 20+ years’ experience spanning digital health and integrated marketing, Todd has a demonstrated track-record of successfully leading customer and cross-functional teams.