How to Define, Design, and Deliver Decentralized Clinical Trials?


Interest in decentralized clinical trials (DCTs) is now full steam ahead – and so is the confusion. The Covid-19 pandemic especially propelled forward the awareness and adoption of DCTs, as sites were unable to stay fully operational during lockdowns. However, even today, there is still much confusion as to what actually constitutes a decentralized clinical trial and who can really claim to be implementing them.

With this in mind, ProofPilot Chief of Strategy Joseph Kim recently spoke to Hassan Kadhim, global head of clinical trial business capabilities at Bristol-Myers Squibb (and writer of an actual research thesis on remote clinical trials!), in the latest episode of his Research Confidential podcast

Defining Decentralized Clinical Trials

Firstly, Joseph asked Hassan how he and his team, as part of a large pharmaceutical company and sponsor of DCTs, define a decentralized clinical trial. Hassan admitted he doesn’t like the term, and so decided to come up with some defining ideas for what constitutes DCTs, through a collaboration with colleagues in IT and procurement. In the end, the clinical trial business capabilities team at BMS outlined four core technical elements that are essential for a trial to be labeled a DCT, namely:

✔️ eConsent
✔️A patient engagement app / platform

They also added four optional capabilities that can augment a DCT model (and potentially become mandatory in the future):

✔️ Direct-to-patient shipping
✔️Home Health
✔️ Metrics dashboards (incorporating analytics)

In addition to the above, one other factor was necessary for a trial to be considered a DCT: a proportion of the study design has to be at home. Which part of the study, or how much should be done at home is not specified, but as an example, some of the study visits would have to be done from home.

Recognizing the amount of work and time needed to implement novel technologies, Hassan’s team chose this somewhat ambitious definition with the intention to drive internal cultural change in a long-term and sustainable manner. Having a strict definition makes it harder for BMS to implement DCTs as defined by their own definition, however, it also provides important clarity, and enables teams to set out requirements clearly to potential vendors from the beginning, and therefore Hassan feels it will be worth it in the long term. And maybe most importantly, if BMS is to measure an ROI on DCTs, the definition needs to be rigorous and crystal clear in order to avoid false positives or negatives with regard to benefit.

One other guiding principle that Hassan’s team strives to abide by in DCTs is keeping the patient burden as low as possible. That is, as well as expanding access to clinical trials, DCTs also enable a greater range and volume of patient data to be collected (e.g. through wearables and mHealth technologies). However it is important that the data being collected, or more specifically, the tasks that patients are being asked to complete - e.g. complete a diary, or collect biosamples - are based on their value to the outcome of the clinical trial, and not just being collected because they can be. Of course, when you rely more on patients, the support given to them has to match the responsibility you expect of them. ProofPilot offers a key capability to Pharma in supporting patients in a wide variety of tasks though our Co-Pilot product.

How to Design and Plan DCTs?

Joseph then asked Hassan about how to go about actually making a DCT work in real life. Hassan felt that for DCTs to work, they need to be “decentralized by design”. That is, the trial, including the protocol, needs to be planned with decentralization in mind right from the start.

Clinical teams need to be asking themselves from early on in the trial planning process where different DCT capabilities (e.g., remote eCOA, telemedicine, remote econsent) can be introduced, or where site visits can be reduced. It is NOT enough simply to plan and design a trial and protocol in the traditional manner and then go back and ‘retrofit’ it for decentralized implementation. In fact, retrofitting will fail. In the end, DCT methods cannot be seen as a hammer that sees everything as a nail - it must be focused on solving a specific problem.

How to ‘Sell’ the Idea of DCTs to the Various Stakeholders?

According to Hassan, this is where one of the largest challenges in implementing DCTs lies. It turns out that highly intelligent, well respected and successful medical opinion leaders are not always the most eager to drop well-established, proven methods, and adopt new, digital ways of doing things.

When explaining reasons for adopting DCTs, Hassan believes that in order to get buy-in from various stakeholders, sponsors should focus primarily on communicating the need to build flexibility and resilience against disruption in clinical trial processes. Also, reminding the research community that, as so many aspects of life became digitized during the Covid-19 pandemic – including grocery shopping, schooling, and even many aspects of healthcare – people have realized that there is another way of doing things, that is, the remote, or digital way. Patients also understand this, and now want more remote functions in clinical trials too, to lift some of the burdens of time, effort, and expense that participating in traditional trials can represent. This is meaningful to clinical teams as well, as it’s not just salespeople from vendors of the new technologies that are pushing the benefits of DCTs - patients themselves are demanding it.

How to Successfully Roll out Decentralized Clinical Operations?

Hassan highlighted the importance of collaboration between relevant teams within an organization, in his case that means especially colleagues in IT and procurement. He stressed the need to ensure the right kinds of (flexible, long term) agreements are in place with the right kinds of vendors, and also that all DCT technologies themselves integrate seamlessly with the sponsor's own systems. If possible, one of the keys here is having partnerships with vendors that can provide more than one DCT solution. After all, introducing five new categories of vendors into a clinical trial just adds complexity - it does not improve efficiency. On top of that, the ability to orchestrate all the tasks, tech and personnel is paramount to success, since the trial is no longer being conducted “under one roof.” Fortunately, ProofPilot’s Digital Protocol Automation platform is built to orchestrate a wide range of tasks and technologies, no matter the setting.

What About the Orchestration of DCTs at Site Level?

This is an industry-wide challenge Hassan felt, and groups such as the Society for Clinical Research Sites (SCRS) and others are working to find solutions to the heterogeneous nature of sites’ preparedness for DCTs. In Hassan’s experience though, there tend to be three types of sites, in terms of outlook towards DCTs: some sites have already invested in their own DCT-enabling technologies and are therefore not willing to use sponsors’ DCT technologies; then there are the ‘technology agnostic’ sites, that will adopt any technology that the sponsor provides; finally there are the sites that are more resistant to using DCT technologies of any kind.

Added to differences between different sites’ approaches, there are also differences in different countries’ regulations that govern how things need to be done. Again, collaboration with relevant internal teams - in this case regulatory - can provide insight into what the requirements and therefore best strategies are for each different country. However, there is still a lack of harmony among sites in terms of approaches to DCTs.

One way to address this is to build specific questions for sites, to assess their readiness for conducting DCTs, into study feasibility questionnaires. The fact remains though that today, many sites are still not ready to conduct DCTs, but in order to generate the data needed to get new treatments approved, such sites will continue to be used, and sponsors will need to accept that the transition to fully decentralized trials will not happen in one step. This is where ProofPilot’s ability to accommodate custom workflows, down to the site level, can really help Sponsors adopt DCT methods with precision and flexibility, while not alienating sites who can still provide value.

Looking Ahead

Finally, for a glimpse of the future, Joseph asked Hassan what success would look like to him in three years’ time. Hassan’s personal definition was simple: for DCTs to be a reality, to be a viable option, that could actually be considered in every study’s design.  Through ProofPilot's Digital Protocol Automation platform, we aim to help Hassan and the industry achieve this vision by simplifying the complexity of DCT implementation.

Joseph Kim


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