Welcome to the November 2020 edition of our DCT blog.
The current discussions around the clinical trial industry are heavily weighted around Decentralized Trials (DCT) and how COVID19 has been a catalyst. This has heighted the awareness across our industry as we are finding many new technology companies entering this space. While many of these companies try to focus on their technology capabilities, the challenging piece of the puzzle that is often not highlighted is the strength and depth of their operational workforce utilizing these digital assets in a fit-for-purpose way. The institutional knowledge that a CRO brings from a molecule to commercialization approach is invaluable as we look to find new ways of offering therapies to patients while utilizing our digital assets for patient diversification, centricity and safety in clinical trials.
Being a CRO, we often talk about the solutions we offer from the lens of capabilities, costs, timelines, and how they connect to meeting sponsor goals or patient needs. It’s very easy to go straight from trial design concepts to plans for NDA submissions while glossing over a lot of the nitty-gritty detail required for successful trial implementation. Often, the place where “the rubber meets the road” – even in trials using DCT methodologies – is the investigator site. To this point, in a survey* earlier this year, only 9% of investigators responded that they were very confident that sponsors and CROs can shift toward hybrid/virtual trials quickly. [*reference: https://pharmaintelligence.informa.com/resources/product-content/the-new-normal-for-clinical-research-in-the-wake-of-covid-19 ] This survey was conducted in May 2020, when the spring peak of COVID-19 had forced many trials to pause, delayed others from starting, and precipitated a shift by many sponsors to taking an urgent look at DCT methods as a suddenly less risky alternative to traditional clinical trials.
We are confident that our approach to DCT will instill a greater sense of confidence for Investigators on their thoughts from a Sponsor or CRO perspective. We have spent this year selecting and evaluating a scalable, flexible, configurable technology platform not only to transform the services we offer, but also to ingrain the operational strategy and execution to become part of our DNA. It’s just the way we do business! Achieving this involves developing the appropriate organizational culture, awareness and leadership alignment to create optimal team structures and processes. This was done deliberately, by accelerating plans already developed, and enabled us to create a fit-for-purpose trial execution capability. Along the way we reinforced connections between different parts of our enterprise… labs, data sources, interactive response technology teams, monitoring staff… and added new capabilities such as our acquisitions of GlobalCare and snapIoT.
As the role of the traditional CRO shifts into a that of a digital and data-enabled partner, it’s imperative to have an operational framework that leverages our core competencies of drug development, with the nimbleness of a technology-enabled approach. Only in this way can we combine the twin imperatives of “diverse patient-centric trials” and “better results, faster” that are at the core of the DCT promise.
The value DCT brings from an operational lens spans across transforming the regulatory landscape, Startup Activities, RBM Activities, Trial Monitoring Plans, Project & Data Management as well Patient Safety. There will be a fundamental shift within roles in the organization towards a value-based activity model, and these are all the elements that truly change the way we do business vs having just a technology solution.
We are excited to be able to synergize the values and response times of Labcorp, especially during COVID-19 and humbled to be a part of transforming drug delivery to be able to make a difference for patients.
We look forward to further insights from the investigator community, as well as patients and sponsors, to continue informing our approach. Our goal is to be able to maintain trial continuity through challenges like COVID-19 and into the future, but we can only accomplish this through continuous evolution of the DCT model. Each new challenge brought to us is reviewed by our team of SMEs and contributes to “the flywheel of innovation” that lets us enable you as the sponsor to develop better drugs, sooner.
Learn more about how we can help you build efficiencies into decentralized clinical trials
You can also find additional DCT resources like case studies, white papers, scientific articles and more.