The Key To Faster, More Efficient Clinical Trials? Patient Centricity – MedCity News


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Jim Reilly

patient engagement

The pandemic forever changed the way clinical trials are conducted. Sponsors and clinical research organizations (CROs) have evolved to support multiple ways of offering trials, supplementing the traditional on-site approach with new, remote methods. With the support of consumer-like digital applications, this new digital approach put the ease of participation for patients at the center of the trial strategy.

These trial models make it possible to expand reach to more patients including rural populations, shortening the time it takes to travel to sites and enabling those who aren’t feeling well or who have traditionally not had access to clinical research to participate.

While progress has been made moving to more digital ways of executing trials, more work lies ahead for the industry. Nearly all sponsors and CROs report significant challenges with site technology adoption and increased burden for technology-averse patients. To overcome these challenges and empower more patients to participate effectively in clinical studies, sponsors and CROs must work together to create a personalized, digital, and seamless site and patient experience.

Eliminate technology burden
While decentralized trials are convenient, patients want easier ways to provide information, such as trial consent forms, surveys responses, and reporting adverse events. Patients are asked to use various tools, such as electronic patient-reported outcomes (ePRO), electronic informed consent (eConsent), smartwatches, wearables and sensors, videoconferencing tools, and more, to report information on vitals or reactions to therapies.

In some cases, each aspect of a study—from registration and communication with the site to reporting for dosage compliance—can involve a different application a patient has to learn to use. This can cause confusion and frustration for patients and affect accuracy if data isn’t correctly recorded or communicated.

Investing in education and training for trial participants on patient-facing technologies can lower the burden on patients and sites that deliver care and serve as tech support for many. Industry stakeholders recognize this need, as 42% of sponsors and 45% of CROs say they are taking action to educate and train patients.

Make it personalized and convenient
Based on patient needs, the experience of participating in a trial should evolve to deliver personalized technology interactions. For example, a 19-year-old participating in a trial for a new acne treatment and an 80-year-old cancer patient taking part in an oncology drug study will have different needs. At any given time, a patient may prefer a telehealth visit on some occasions and in-person visits for others during the same trial.

How can the industry address this dichotomy? First, by understanding that trial participants have lives beyond the trial. Patients might have jobs, children, and other commitments. Companies need to consider how a trial fits into a patient’s life. Participating in a study should be seamless and straightforward while providing multiple options to complete requests. Older patients may prefer human contact, so offering a hybrid care option would provide the flexibility that this patient population needs. Likewise, sponsors should strive for simplicity when it comes to the technology they offer patients throughout their experience. Patients want simplicity in their personal lives—and the same holds true for clinical trials. Offering them a single app to use throughout the trial process is much easier than trying to get them to use multiple—both for the site and patient.

Added complexity to daily life is likely why patient dropout rates remain high, with 19% leaving studies before completion. Truly patient-centric trials will allow for broader participation, allowing patients to decide how and when they want to engage in a study.

Connecting the dots through digital clinical trials
Companies are starting to expand beyond decentralized models to design digital trials that are more connected across stakeholders. Digital clinical trials link sponsors, CROs, research sites, and patients for seamless information sharing. Using applications on a single cloud platform enables life sciences to lower patients’ burdens and execute paperless processes, fundamentally transforming how trials are run.

A digital trial allows data to flow automatically across patients, research sites, sponsors, and CROs, ensuring no information is lost, and all stakeholders have access. This increases trust among patients since they won’t need to repeat the same step or navigate multiple technologies. Sponsors can also quickly use and analyze the data to determine next steps in the trial while site processes are streamlined and automated.

When clinical trials are patient-centric at their core, research sites and sponsors can achieve better engagement levels, high-quality data, improved retention, and even repeat participants. By embracing a platform approach to technology for clinical trials, companies can deliver convenient and personalized experiences to patients.

Photo: mathisworks, Getty Images

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