Prior to the COVID-19 pandemic, there was a trend toward decentralized clinical trials (DCTs). DCTs are trials in which some or all of the participant visits occur outside the traditional clinic or hospital setting and separate from the investigator. They often employ communication technologies (e.g., telehealth platforms, smartphone-based apps), digital health technologies (e.g., remote sensors, and other wearable devices), and home health solutions. During the height of the pandemic, many clinical trials were put on hold because of restrictions against nonurgent care and the risk of acquiring the disease. Sponsors and some contract research organizations (CROs), such as PRA Health Sciences (recently acquired by ICON plc), were able to continue some trials by further leveraging DCTs. However, it's not as simple as flipping a switch. There are four approaches that ICON, for example, found useful in operationalizing decentralized clinical trials (DCTs).
Not all indications or clinical studies are appropriate for a decentralized approach. Sometimes face-to-face subject-physician interaction is necessary, such as in certain types of cancer trials with complex procedures and intense and specialized safety assessments. However, when appropriate, DCTs can accelerate trial conduct, create a wealth of high-quality data and improve efficiency. Perhaps more importantly, a key advantage is participant-centricity, meaning the protocol is designed and operationalized to make it easier and more convenient for participants to engage in DCTs, which helps with recruitment and retention, which in turn can help keep DCTs on schedule.
4 Considerations for DCTs
Maria Harrison, senior vice president of Decentralized Clinical Trials and Real World Solutions for ICON notes that making a DCT work involves "change management. It requires a different way of thinking to execute. There's no secret recipe."
There are, however, more effective approaches. Harrison cites four top considerations for conducting DCTs.
Feasibility. That's straightforward, as mentioned above. Not all indications or clinical studies lend themselves to a decentralized structure. Hybrid DCT models that utilize some decentralized components such as sensors, mobile apps or telehealth visits can be used in addition to site visits. Harrison says that it comes down to a simple question. "Do we have the resources and expertise to do it?"
Write a Protocol. It's far easier and less likely to develop hitches if you start at the beginning and write a protocol for a DCT rather than "where you simply rewrite the protocol to wrap it around the participant," says Harrison.
During the height of the COVID-19 pandemic when most clinical trials were put on hold, there were many cases of CROs and sponsors making dramatic shifts from traditional site-visit trials to DCTs in mid-stream. Although some were successful, most found that the transition came with obstacles that could have been avoided had the studies begun as DCTs.
Types of Data and Data Flow. Because the data is coming from even more locations, often in a continuous stream if mobile apps or sensors are being used, the types of data being collected and how it is being organized becomes a challenge. This increased amount of data provides great opportunities for researchers, but standard data management practices don't allow for efficient or effective detection and resolution of anomalies. Issues such as duplicative data entry, data accuracy, interoperability, accessibility and cybersecurity and privacy all become elements to consider. However, with planning, they can be overcome and, as Harrison points out, provide a better "participant journey" with richer data.
Apostolaros et al. wrote in 2020, "Sponsors, CROs, and other parties (e.g., information technology vendors) handling data should control and manage data flow (e.g., data use agreements, service level agreements), as data in DCTs may be transferred to and stored among several different parties, locations, and systems. It may be prudent to start with the trial source data and then map data flow, reconciliation, and storage based on how data reliability and integrity are assured, including data control and security."
Regional and International Considerations. Harrison says that it's important to consider the regulatory environments of the different regions or countries where DCTs are being conducted. Some may have restrictions on telehealth or eConsent, for example. Other considerations such as Internet connectivity and bandwidth, language support for deployed technology, and cultural considerations in deploying home nursing.
Within the U.S., DCTs are often required to manage licensure for participating practitioners on a state-by-state basis. Although Apostolaros et al. indicate that in recent years, telemedicine laws have become more uniform across states, there are still important differences. Those differences can be even more significant in multi-country DCTs.
Decentralized clinical trials are maturing and according to Agrawal et al., 2021, investigators are predicting at least threefold increase in remote participant interactions continuing immediately after the COVID-19 pandemic. Factors making this possible include comfort with communication and digital health technologies, such as fitness wearables and physicians' increasing familiarity with remote technologies; the critical need for participant convenience, or "patient-centricity"; improving tools for remote data gathering and regulatory acceptance; and partner ecosystems, such as those offered by ICON and other CROs.
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Agrawal G, Moss R, Raschke R et al. No place like home? Stepping up the decentralization of clinical trials. McKinsey & Company. June 10, 2021. https://www.mckinsey.com/industries/pharmaceuticals-and-medical-products/our-insights/no-place-like-home-stepping-up-the-decentralization-of-clinical-trials
Apostolaros M, Babaian D, Corneli A et al. Legal, Regulatory, and Pratical Issues to Consider When Adopting Decentralized Clinical Trials: Recommendations From the Clinical Trials Transformation Initiative. Therapeutic Innovation & Regulatory Science. 2020;54:779-787. https://link.springer.com/article/10.1007/s43441-019-00006-4