Jennifer’s career as a clinical data management and clinical development executive has given her unique insights into where the industry is headed. She thinks DCTs are TNBT (the next big thing).]
Scientific research is challenging. Scientific research on human beings is even more challenging. Factor in a global pandemic that altered nearly every form of human interaction, and you have the perfect storm to drive the clinical trial industry to change course. The good news — perhaps one of the few silver linings to emerge from the COVID-19 pandemic — is that this has largely been a change for the better. Clinical trials are quickly becoming more participant-friendly (and more provider-friendly) through the broader adoption of digital technologies.
The change is long overdue. For years, clinical research trial protocols were designed around accommodating the investigative site, and they rarely thought about the patient experience as an element to inform the study design. But as society at large grapples with and overcomes challenges with remote workers, online shopping and mobile banking, understanding and improving the user experience has taken on added importance within the technology space. Concepts such as user experience (UX) design and mapping engagement around personas, which have been a part of the business-to-consumer world for years, are now quietly working their way into clinical trial designs.
Nowhere is this more evident than in the idea of decentralized clinical trials (DCTs). As COVID-19 made it harder for clinical sites to connect with participant pools and administer on-site services, trial developers began to look for better ways to connect with people and collect data. Decentralizing certain aspects of the trial, whether it was signing consent forms or logging in patient data, made it easier for overburdened doctors and nurses to continue their research without monopolizing what little free time they had. Decentralizing tasks also made it easier for patients to participate in these trials from the comfort of their own homes, measurably increasing the available pool of participants at a time when on-site clinical trials were experiencing the opposite effect.
Although DCT is still in the early stages of adoption, there is vast potential in decentralized trials, from patient-reported outcomes to expanded fields of study. But there are challenges as well, particularly around data collection and validation. For example, DCTs have the potential to collect large amounts of data, which can be a boon or a burden if trial developers need to justify to regulators why specific data is collected and how it’s used, which is often the case. Successfully incorporating DCT requires pivoting to a data-led approach for clinical research that allows you to build with the end in mind and quickly handle change. Pivoting to a data-led approach means understanding not only the data sources of the past and present, but also the data needs of the future. Only then can you build systems and solutions that are agile and flexible enough to support current and future needs without creating data silos or requiring stepwise data transformation that simply moves work around.
Over the next few years, clinical trial developers will incorporate more aspects of decentralization into their trial designs with an eye toward improving the patient and provider experience. In a sense, COVID-19 showed us how inefficient the old system was, just as new technologies like online health portals, artificial intelligence, machine learning and automation are showing us how much better that system can be. Working harder or hiring more people to do manual activities or manage overly complex workflows isn’t a sustainable solution. Moving to more optimized processes through intelligently applied technology is our best path forward.
Today, we know from existing data that DCTs have a positive impact on patient enrollment and participation. Tomorrow, we may have the data to show that DCTs lead to faster and more effective outcomes. And if COVID-19 taught us anything, it’s that time always brings change — in this case, change that will lead to a better future for clinical trials.