How to Improve the Patient Experience While Extracting More Precise Outcomes from Your Clinical Trial

The patient experience. Patient-centricity. Patient engagement.

If you work in the clinical trials space, these terms are likely front-of-mind. In recent years, trial sponsors and facilitators have strived to improve the clinical trial experience for patients, in turn facilitating easier recruitment, expedited trial completion, and enhanced brand reputations.

Decentralized trials offer sponsors multiple opportunities to improve the trial experience for participating patients. Such trials inherently remove friction and complexity from the patient experience by bringing trial activities directly to the patient rather than requiring the patient to come to a study site. According to McKinsey, 70 percent of trial participants typically live more than two hours from trial sites. By removing the burden of attending the site in-person, trial sponsors automatically create an improved experience for a wider, more diverse population of patients.

In the wake of the COVID-19 pandemic, the prevalence of decentralized trials has grown and will likely continue to grow in the coming years. The increased interest in and adoption of decentralized trials offers trial sponsors the opportunity to continue enhancing the patient experience, certainly—but it also presents exciting new opportunities to collect, analyze, and utilize trial data.

With the right technology, trial sponsors embracing decentralization can do more than craft a stellar clinical trial experience for their patients. Here’s how trial sponsors can leverage a secure, validated, all-in-one platform like iTakeControl (ITC) both to enhance the patient experience and to extract more precise outcomes from their trials.

Improving the Experience with Decentralized Trials

Decentralized trials allow patients to participate in trials more easily, and they remove burdens—including cost, time, and ease of access—typically associated with conducting assessments in-clinic. The benefits extend beyond the ability to avoid traveling long distances; when they participate in decentralized trials, patients also avoid long wait times based on clinician ability. Decentralized trials give patients and clinicians alike the opportunity to complete assessments when most convenient for them, as opposed to at a pre-appointed time. Tools like ITC’s Virtual Trial Platform, which supports at-home video visits, enable these types of trials.

Trial sponsors can realize commensurate benefits by decentralizing. Without needing to limit their search for patients to a confined geographic region, sponsors can widen and diversify their pool of potential participants. Reduced or removed burdens make patient recruitment easier and can expedite the trial process, including improvement to patient retention. Moreover, decentralization can save trial sponsors the costs that accompany running a trial in-person, on-site.

With the right tools, trial sponsors can realize benefits that extend far beyond improving the experience, increasing convenience, and reducing costs. These benefits can also lead with increased patient compliance to trail design. Ultimately, these technologies can enable them to extract more precise outcomes than would be possible with an in-person trial—and allow them to reimagine how they collect and analyze the data that emerges from future trials.

Extracting More Precise Outcomes from Decentralized Trials

Creating an excellent and convenient experience for patients has become table stakes for sponsors of decentralized trials. With an all-in-one platform like ITC, sponsors can ultimately create an innovative, next-generation trial that extracts more precise outcomes and widens the possibilities of the trial itself.

With ITC’s platform, it’s not just easier for a patient to participate in a trial; rather, the platform enables the collection of more quantifiable statistical data from various types of assessments.

In a standard clinical trial, a clinician observes a patient and writes a record of those observations. In a next-generation, video-based decentralized trial, a patient records a video that a clinician observes. The assessment need not stop there, however—the clinician can review the video an unlimited number of times and uncover new and/or more precise insights with every viewing.

What’s more, video collected and reviewed via ITC reduces the risk of user error that could occur more easily in a standard in-person trial. “If you record a video, you can slow it down, stop it, have different folks review it, and ultimately have a great level of reliability of your clinical data,” says ITC partner Scott Bergeron. “If there’s ever a question [about a certain aspect of the data], you can go back and verify its accuracy. That provides a completely new standard for accuracy in the research space.”

How the ITC Platform Works

ITC offers an end-to-end process for capturing, reviewing and scoring video assessments remotely. The all-in-one platform facilitates easy onboarding of patients through a secure study management portal, where trial participants can complete registration and e-consent forms and staff can undergo any needed training. The platform also allows patients to record and upload video data from the comfort of their homes, while enabling clinical raters to review these videos as often as needed at their convenience and record their data (scoring).

The ITC platform is endowed with the highest levels of security. Audio and video data remain within the system the entire time, which reduces the risk of exposed data. Patients are automatically de-identified, metadata associated with each recording is retained, and clinician scores are automatically transferred to an EDC through a secure API.

This platform enables increased precision in multiple ways. First, it provides a repository of clinical data for previously undefined endpoints, which enables clinicians to re-analyze videos without needing to have the patient re-perform the assessment. Second, video inherently offers a greater level of accuracy and reliability in clinical data than do written records. Third, the ITC platform offers the ability to make raters blind to the time point as they review video assessments, which provides an opportunity to remove bias and increase precision of results.

Invest in Clinical Trials of the Future

The clinical trial industry has reached a new normal in which decentralized trials may soon become the norm rather than the exception. Savvy clinical trial sponsors will leverage technology like ITC not only to improve a patient centric approach for those who participate in their clinical trials, but also to reimagine the limits of clinical trial data collection and review.

Interested in learning more? Reach out today for a conversation about how ITC can support your decentralized clinical trial.