The future of clinical trials is taking the road of digitalization and modernization. Thanks to the advancements made by the FDA, the foundation for digital health has been laid down, resulting in the evolution of patient-centered approaches.
Although the draft guidance from the FDA is quite vague and does not define digital health use in clinical trials directly, it provided the groundwork to objectively measure outcomes in trial endpoints.
Suffice to say that the industry is approaching a new age of clinical trials.
According to chief operating officer of clinical research organization ICON, Steve Cutler, “Clinical trials are getting more complex and increasing amounts of data are being collected,” requiring better approaches to meet the challenges presented by the “increasing numbers of patient subgroups, difficulties in finding those patients, and trials in rare diseases and orphan drugs becoming more common.”
Three Main Technologies
In a report published on Accenture’s website, managing director Kevin Julian pointed out three main technology categories that could reshape clinical trials – cloud, analytics, and mobile.
Where digitalization across R&D is concerned, a cloud is not just a hosting and storage unit. It is also “a means to seamlessly integrate and collaborate with external partners,” says Julian. Using the cloud has become a significant trend in R&D.
According to Julian, better analytics will allow staff to “make much better decisions about whether the product is performing the way the company wants it to earlier on in the process.” Based on the findings, adjustments can then be made in a timely manner; something that was impossible in the past since data collection tends to be slow and cumbersome.
This refers to wearables and other smart devices that help with investigator interactions and patient enrolment. Julian used Fitbit as an example, where a patient receiving treatment and wearing it can provide a “very objective set of patient data that is more encompassing of your real-world experience … see what someone’s mobility is like, you can see how many steps they took a day before the trial and during it, you can see how someone sleeps”.
In addition, digital technologies will revolutionize patient recruitment, electronic health recordkeeping, and cloud and collaboration.
As for health records, technology can resolve any inefficiencies in finding where the right patients are. Cutler believes that greater access to electronic medical records will provide the right direction in finding prospective participants.
The future of clinical trials may also include carrying out remote trials, a concept that the technology and consulting company eClinicalHealth has already experimented with. They tried it in the phase IV of the VERKKO remote online clinical trial for diabetes.
For changes in clinical trials to happen, however, mindset changes must first happen, according to Cutler. He believes that some pharma companies may be slow in doing this. But due to significant pressure, they will work to improve their part in taking clinical trials to the digital and modern world.
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