Has the Fully Digital Clinical Trial Finally Arrived?


A fully digital clinical trial – where patients can participate from the comfort of their home – seems like a pipe dream. But as it turns out, it might not be.

It’s no surprise that the healthcare industry is turning to tech to streamline clinical trials. Trials continue to struggle with patient recruitment and retention, attempting to manage skyrocketing costs while finding enough patients to continue their studies.

More and more trials are turning to patient centricity as a solution to recruitment and retention issues. Although new technology is improving the patient experience over time, the holy grail is the site-less, fully digital clinical trial. This may sound ideal, but just how close are we to achieving this goal?

Finding the Golden Goose

As it turns out, we may be closer than we think to fully digitized trials. In 2011, Pfizer and Exco InTouch launched the first major attempt to conduct a randomized clinical trial. Patients enrolled online and then participated entirely from home through drug delivery and a mobile app. But only a year later, the trial was discontinued due to lack of enrollment.

Though the 2011 experiment was unsuccessful, subsequent attempts have validated what Pfizer set out to do. Two trials – one in 2015 and one this year – were successfully able to conduct studies remotely without a centralized trial site or CRO involvement. Administrators involved with the trials reported faster recruitment, a wider selection of participants, and more robust data sets.

Patient Centricity

For a digital clinical trial to be successful, a focus on the patient experience will have to take center stage. Since trials won’t be able to monitor patients through regular visits, it’s in their best interests to make patient-friendly adjustments that improve retention. This means abandoning stacks of paperwork or lengthy journals in exchange for wearable sensors or voice-enabled data capture.

Thankfully, new technology has made it easier than ever before to develop tools for remote monitoring and patient adherence. Especially notable is Apple’s ResearchKit, which trials can use to build smartphone apps to the protocol’s specifications. Digital trials may also be helpful in testing this technology – if we can prove the usefulness of these technologies with post-market drugs or therapies, trials can start to put them to use more quickly.

Determining a Timeline

The question now becomes: when will digital trials become commonplace? Up until this point, clinical trials have been slow to adopt new technology. But as we begin to see proof points for the value of digital trials, concerns will fade and sponsors will embrace innovations that make trials more convenient for patients, minimize costs, and speed up the research process.

It helps that the FDA has recently released a new mandate for how it will approach software and mobile health technology, which will speed up the regulatory process and lend credibility to the platforms and sensors that enable remote trials. The agency will still prioritize safety and efficacy, but will open some additional pathways for streamlined evaluation and approval.

Fully digital trials probably won’t become reality for another 10 years, but we can expect some improvement In the short term. The first innovations that trials will adopt will likely solve two problems: remote monitoring and data integration. We’ll see greater adoption of medical-grade sensors, as well as the development of digital platforms that collect all the data related to a given patient in one convenient place.

Even if digital trials aren’t just around the corner, clinical trials can take steps to improve patient centricity within the next few years. Every time a trial adopts new technology, the medical community brings a fully digital future just a little bit closer.

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