Decentralized Clinical Trials – Looking beyond the Pandemic
November 12, 2021
Since the start of 2020, many conversations have begun with COVID-19, so let’s go there and get it out of the way. Arguably, COVID-19 was the catalyst which propelled Decentralized Clinical Trials (DCT) into the clinical trial mainstream. However, the question we should be asking is whether the current baselining of the pandemic will push DCT back to the fringe where it languished to the end of 2019? We think the answer is most definitely not.
Over the decades, there have been advances in clinical trials that have been slow to pick up but have been game-changing when they do. An example of this is the switch from paper CRFs to EDC. This change took years to crystalize and some clinical trial veterans treated the conversion like some sort of magic that couldn’t possibly be good for science. Well, the conversion eventually happened and now we look back with fond reminiscence on paper CRFs and the (carbon-copied) challenges they provided us. The same could be said for DCT, except the pandemic drove the transition and we skipped the ‘magic not being good for science’ stage.
2020 and 2021 brought huge advances in the thinking and practice of how we conduct DCT. The industry introduced large-scale DCT IT platforms, making telehealth and home health visits the norm. We created complex systems for housing all of our DCT initiatives, from scheduling appointments, to eConsent, to Quality of Life Assessments, EDC and a myriad of others. We made systems so complex and comprehensive we made Skynet look like a 1990’s PDA.
As we look forward to 2022, there is the excitement of having the choice of modular and hybrid designs for DCT. We can take a look at a protocol and work out what’s best for that project. Perhaps introduce a few telehealth visits or we can get a mobile phlebotomist to a patient’s home to do a blood draw. Maybe we add a connected device for an eCOA assessment or eConsent. Essentially, through necessity, we rapidly filled our DCT toolbox with options that we can now, cleverly and with precision, pick and choose the best tools for each study.
Creating a protocol from the ground up to be hybrid or 100% DCT is critical. Assessing the scientific needs of the study, tying this in with the schedule of assessments and then working through which visits and assessments can be done remotely will be important in reducing the site and patient burden. We can also be smart in the way we assess procedures for DCT. For example, we love the idea of eConsent as it fits in with our tech-heavy way of working, and our preference to do things on our phones or tablets. But, is there any point in committing this expenditure to the development of this solution if the first visit on a study has to be in the clinic?
In summary, DCT is here to stay. As an industry, we have developed the tools we need to implement this quickly and effectively and, with smart application, we can make a huge improvement on the patient and site burden.
For DCT, the future is very bright indeed.