Recruitment into clinical trials can be a testing task, leading to a push more recently into patient-centric approaches. Technology is a major resource in this respect but there are some important aspects to consider as Mike Novotny, founder and CEO of Medrio, discusses further.
clinical trials
A great deal of recent research has looked into the top challenges the clinical research industry faces today, and the conclusion always seems to be the same: Patient recruitment is among the greatest obstacles, if not the number one, that researchers say stands in the way of clinical trial success. As a result, the industry has seen a great push, in recent years, to make clinical research more patient-centric, expand eligibility criteria, and thereby shore up enrolment numbers enough to keep their studies moving.
Technology has been a major resource for organisations who have embarked on these endeavours. How does technology play a role in patient centricity, and what do organisations need to consider as they begin to take advantage of it?
Meeting the needs of patients
Among the greatest factors behind the recruitment and retention struggles the industry faces are a wariness of unproven treatments (often referred to as the ‘guinea pig fear’) and the fact that, for many potential clinical trial subjects, committing to regular site visits over a period of months or years is inconvenient or simply unfeasible. In this light, it will be interesting to see to what extent organisations utilise advancing technology to mitigate these challenges.
As patient reported outcomes, for example, go electronic, researchers are empowered to better demonstrate an investment in the patient experience and ensure patient safety and comfort. And as conversation continues to swirl around mHealth and wearables in clinical trials, one can’t help but wonder about the patient-centricity value of these methods of remote data collection: The ability to collect data remotely, without a site visit, could significantly reduce the burden of clinical trial participation.
It’s necessary, however, to keep any optimism cautious. For the use of next-generation technology to truly be feasible, there are some important considerations. For one, any technological platform in use for remote data collection will need to be able to transmit that data to the central EDC or other eClinical system in use in the study; APIs will need to be in place to streamline integration, so that manual data transfer doesn’t slow down study timelines. It’s not enough for a wealth of technological solutions simply to exist; they need to be able to work with one another, as well — and until they do, it won’t be feasible to harness them for patient centricity or any other purpose.
What do regulators have to say?
Then, of course, there’s the regulatory question. During technological boom times, the creation of innovative solutions can outpace the evolution of the regulatory frameworks that govern their use. In an industry as sensitive to regulations as clinical research, this is an essential consideration.
The good news, however, is that major regulatory bodies have recognised the promise of innovative clinical trial technology, and have moved to announce their encouragement and develop guidance around it. Since 2013, the FDA has been officially in favour of eSource; just in the last year or so, institutions ranging from government, non-profits and the private sector have collaborated to hash out guidance and recommendations for the use of mHealth technology in clinical trials.