All-in-one vs. one-site-fits-all: choosing the right DCT partner
In the world of decentralized clinical trials, there are numerous technologies, services, and components that can be used for decentralization. It is important to understand Why the DCT Model Isn't "All or Nothing", in order to comprehend how different decentralizing elements exist across different types of trials. For instance, a digital therapeutics (DTx) decentralized trial might be 100% remote using a virtual site model and eClinical platform, whereas a diagnostic DCT could be using a community care site model to recruit patients in person from their local care facilities where they went to seek treatment for an acute illness. Both of these are examples of DCTs however, they use decentralized technologies, services, and other components differently to best execute their study.
It is commonly understood that not all clinical trials are compatible with all DCT elements and therefore sponsors utilize DCTs differently in each study and need DCT partners that can help them do so. When sponsors are selecting their DCT partners for these trials, they may typically be presented with two different approaches, the first, a one-size-fits-all approach, and the latter, an all-in-one approach. This blog compares and contrasts the two approaches to help clarify their meaning and identify key differences and factors to consider when choosing between the two.
The one-size-fits-all approach refers to DCT vendors that have a set decentralized offering that caters to a specific study model. This type of vendor likely has a fixed procedure of decentralizing studies that meet certain criteria and follow a set structure to implement the DCT components. There is minimal malleability in how these DCTs can be designed and what elements can be implemented due to the set nature of the approach.
An example of this approach would be a DCT vendor that offers a software platform with capabilities such as telemedicine, screening, eConsent, ePROs, etc., to allow patients to participate in study components virtually. The DCT vendor will deploy this software platform to specific studies meeting their criteria and likely offer the same technology no matter the type of study. Sponsors meeting specific criteria with the right site model can incorporate this trial platform into their study. In this instance, if a sponsor is looking to incorporate more than a software platform into their study, they may need to find other vendors to do so.
An all-in-one approach refers to a DCT vendor with multiple technologies and services that were built to be flexible enough to address sponsor needs and can execute a decentralized trial from start to finish. The all-in-one approach lets sponsors choose the decentralized components their study needs, all of which are provided by one DCT partner.
An example of this approach would be a DCT vendor offering an eClinical software platform in conjunction with acting as a virtual site and technology-driven CRO. In this example, sponsors looking to run their decentralized trial may work with this DCT vendor to choose the right software platform capabilities, site models, recruitment strategy, etc., to take their study from start to finish with one DCT partner. However, if this particular sponsor wanted only the CRO and eClinical platform, they could choose to do so with the flexible all-in-one model.
Similarities & Differences
DCT vendors are likely to have similarities among their offerings, particularly when it comes to clinical trial software platforms. It is common to offer standard software abilities such as telemedicine, ePROs/eCOAs, eConsent, etc. However, the quality and capacity to perform are likely to vary between vendors. This also applies to trial recruitment. Many vendors market their patient recruitment capabilities, but, the ability to do so successfully varies greatly among vendors.
It can be easy to confuse similarities in language with similarities in services. While vendors may claim to be “full service”, “end to end”, or “purpose-built” these terms are not standardized across the industry to mean the same thing. In reality, the comprehensiveness of the services and technologies being offered vary greatly from vendor to vendor. This guide can aid in clarifying some of this language: The Ultimate Guide for Selecting a Full-Service DCT Vendor.
Take a look at this blog to learn more about common terms in the industry: What universal alignment of industry terminology means for decentralized research.
Why do we need to differentiate?
The one-size-fits-all approach is more rigid in nature in the sense that it can only be applied to certain types of studies. In the example given above, despite the numerous capabilities of a decentralized clinical trial software platform, software covers just one part of running a trial. There are many other factors that this software platform has to be compatible with in order to succeed, limiting its applicability to various study types. If this sponsor is interested in incorporating other trial decentralization components such as a DCT-compatible CRO or site, they will likely need to seek a third party to do so due to the one-size-fits-all vendor having a limitation to what they can offer and how they can execute.
The all-in-one approach gives sponsors optionality which in turn empowers sponsors to offer patients participating in these DCTs optionality as well, which promotes a patient-centric focus and can boost patient engagement and retention throughout a study. By being able to equip sponsors with everything they need from finding PIs, in-house CRCs, multi-channel recruitment strategies, acting as a CRO, virtual and hybrid site capabilities, etc., the all-in-one approach lets sponsors pick and choose the right decentralized components for their study. Furthermore, if sponsors have specific concerns or pain points they anticipate through the study, they can work with an all-in-one DCT partner to implement specific DCT solutions to directly address these.
Why is this important?
Running a clinical trial can be challenging with balancing staff burden, resource allocation, costs, patient recruitment, engagement, retention, complying with regulatory body guidelines, and more.
The purpose of DCTs is to expand patient access, diversify participant pools, alleviate site burden and cost, accelerate timelines, offer patients optionality, and remove unnecessary geographical barriers, and the right DCT vendor can help sponsors accomplish this in an efficient way.
Having the ability to decipher between different DCT approaches and easily identify the DCT provider capable of executing an individual study, reduces the confusion and stress that may come with sifting through to find the right DCT partner.