At Medable, we’re always looking to understand the changing environment of clinical research, and how we can help customers overcome the various challenges, risks, and scenarios that these changes bring.

For the past year, I, various clinicians, and research experts at Medable have been working closely to improve how we conduct research for various therapeutic areas. Much like the results shown in Tufts CSDD’s latest whitepaper, we believe that a well-thought, decentralized approach can help bring new therapies in historically challenging therapeutic areas to markets faster.

The result of this work is a brand-new decentralized approach we’re bringing to the market.

What is Your Therapeutic Area Approach?

We have a holistic approach that pairs the needs and challenges within a particular therapeutic area with a tailored set of decentralized solutions (eConsent, eCOA, TeleVisit, etc.) that will solve them, by leveraging our deep DCT experience as well as understanding and addressing the unique challenges of each TA. The solution set is customized to provide a bridge that’s bespoke to the challenges of that particular therapy area. Thus, our approach for vaccines is different from our approach for cardiovascular metabolism, which is different from our approach for oncology, etc.

The first TA to embrace this approach, which we launched in June, is our Vaccine offering.

As part of this, we established the vaccine pre-build following discussion with external and internal cross-functional experts in Clinical Operations, Engineering, and DCT best practices. 

How we Constructed our Vaccine Pre-Build

To best understand the challenges that vaccine and infectious disease research faces, we engaged expertise from both within Medable as well as partners and customers.  From these discussions, it was clear that there were broad operational similarities across vaccine studies such as a high reliance on PROs, the need for flexibility in deployment, a high volume of participants, a need for increased diversity or participation, and the real-time availability of safety data.  All of these suggest that vaccine studies would lend themselves well to a DCT approach, however, the uptake of DCT solutions across vaccine research was low.  One of the key reasons was due to the time taken to implement new, digital solutions across studies that needed to be started up and conducted relatively quickly.  Therefore, we focused on understanding how we could define a fit-for-purpose solution that could be deployed rapidly without compromising on participant safety or the robustness and quality of data collected, whilst also addressing the operational challenges mentioned above. 

To begin, we looked at historical vaccine studies, extracted the core operational similarities, and used this to create a mock protocol. We built this protocol as if we were building a net-new study for a sponsor, following the same processes of assigning a designated team, preparing a study specification document, and running through our standard engineering build process and testing. However, throughout this build, we tasked the team to keep in mind that we wanted to understand how to build efficiencies to allow for easier use in subsequent studies, such as ensuring the opportunity to “switch off” certain customizations as needed or to maintain flexibility in operational aspects such as visit schedules.  The philosophy behind this exercise was to allow for a templating approach and minimize the need for a “ground-up” build for every new study.

As we went through the specification and build process, keeping in mind the specific TA challenges, we were able to identify the core build components and their structure, including creating a bespoke electronic pre-screening step, defining the appropriate steps to enhance participant engagement, identifying the key data needs for sites and sponsors and by creating purpose-built reactogenicity and surveillance diaries, ensuring that we would be able to answer the questions of the majority of vaccine studies using this template. This allowed us to create an industry-first multi-modal single platform DCT offering that can enhance engagement, improve the experience and deliver data quickly with a rapid, scalable, and sustainable solution to meet the core needs of vaccine studies.

The Benefits

Circling back to the speed of deployment as one of the core needs for vaccine research, by employing our vaccine pre-build template, we are able to launch a DCT-ready vaccine study in as little as 5 weeks from a final specification to “go live.”  Whilst we address other key TA-specific challenges, all of this is alongside the other advantages of employing a DCT approach to clinical trials. 

These advantages are:

  • Tufts CSDD research found that DCTs can provide substantial net financial returns — with cycle time reduction as the largest contributing factor — to sponsors who invest in, and deploy virtual and remote clinical trial solutions;
  • Tufts CSDD benchmark data suggested a nearly 10% reduction in clinical trial timelines associated with DCT usage;
  • Although protocol amendment experience associated with DCTs had a smaller relative impact on the return in DCT investment, benchmark data suggested a 27% reduction in phase II and a 6% reduction in phase III protocol amendments

Additionally, we’re proud that the tools, processes, and methods that Medable employs have been proven to improve patient engagement and data capture and reduce traditional trial conduct timelines by 10% or more.

An increasing global focus on immunization, clinical research, and the ubiquity of digital technology reinforces the need to optimize vaccine trials with a DCT approach - at Medable we’re ready to lead the charge.