By: Patrick Smith
This post is part of a blog series on what we believe the responsibilities of eClinical technologies to be in a time of increasing demand for trial decentralization. Here we examine the need for Diversity. If you are looking for a more detailed dive into our thoughts on the matter, please consider taking a look at our whitepaper.
When we say that technology used for decentralized trials must improve diversity, we’re speaking specifically to expanding the typical reach of sponsors and CROs in their efforts to locate patient populations. This is one of the most pronounced benefits of this industry-wide shift into decentralizing clinical operations. Use of ePRO and eCOA, and the expanding portfolio of sensor-based technology, all allow information to be collected closer to the patients themselves. By effect, allowing clinical trials to reach new patient populations that were traditionally excluded by more site-centric models.
But what does it mean for the ecosystem of eClinical technologies to support diversity? Decentralized and hybrid trials improve diversity naturally, by design, but only if the systems underlying the whole process can support it. ePRO may allow you to collect eSource information directly from patients, but the system needs to be seamlessly integrated with your EDC housing patient casebooks.
If these complications are unaddressed by technology, they can very quickly erode any benefits offered by new approaches to clinical research.
Technologies like DT Direct streamline the addition of eConsent and eCOA to clinical programs. Using a simple intuitive application available on the web or from any mobile device, we are able to enroll and consent patients in clinic alongside their physician, or in the comfort of their own homes. When direct patient data is captured and sent to the EDC, it is automatically scrubbed of any protected health information. During a trial, the same patients are able to complete surveys, eDiaries, and collect sensor data on their smartphones or laptops without having to take time out of their lives to travel to a participating clinical site. This fact alone can dramatically improve enrollment rates, compliance, and patient retention.
It is not uncommon for patients participating in clinical research to face travel times on the order of hours to complete their scheduled site visits. Reducing this burden on subjects allows the benefits of clinical research to reach communities that may be distant from major cities, or people who simply cannot balance the time requirement of traditional trials with those of their work and families. Most trials fail to recruit enough patients, and among those recruited, dropout rates remain consistently in the low double-digits across trials. Finding willing participants is only part of the mission here. Ensuring the end-to-end experience of the trial is one of trust, safety, and convenience is critical to ensure patient retention.
We enable convenience by providing intuitive tools for the design of clear electronic consent forms and diaries. They allow the inclusion of multimedia supplementation like audio and video, to ensure patients always have a well-informed picture of what is expected from them and what they should expect further down the road in the trial. Automated notifications allow subjects to remain compliant with the guidelines of the protocol without needing to invest any more of their time and attention on the trial than is necessary. People do us all a great service by agreeing to participate in the advancement of medical research. It is a good place to be in as an industry when we realize that focusing on greater inclusion, comfort, and convenience for our subjects is a benefit to everyone.
Diversity is arguably the most significant outcome of a move towards trial decentralization. It promises to simultaneously allow more people to benefit from clinical research, and improve the efficiency and effectiveness of the whole industry. In supporting diversity, the role of eClinical technology is to provide a guarantee to those questions above. It is our responsibility to ensure these new kinds of clinical trials can be designed, and that they can collect information from new sources safely, efficiently, and with little to no burden on the teams and patients they support.