Clinical Researcher—February 2022 (Volume 36, Issue 1)

SPECIAL FEATURE

Stacy Weil; Nicole Carswell

The data are clear: Decentralized clinical trials (DCTs) are on the rise.

In July 2021, the Industry Standard Research (ISR) Report on Hybrid/Virtual/Decentralized Clinical Trials Market Outlook surveyed 109 industry leaders worldwide who had been involved in DCTs over the past year.{1} Respondents anticipated a 12% increase in hybrid trials over the next two years—and predicted that DCTs would outstrip traditional trial models within three years. They praised the increased ease of patient recruitment and improved patient compliance that DCTs generate. They were also impressed with the access to rich data—often sampled multiple times a day—representing a trove not possible with traditional trials.

Yet that does not mean all is perfect. DCTs—including for our purposes the range of hybrid onsite/offsite, siteless, remote, and virtual trials, depending on your favorite terminology—rely heavily on technology for data capture, and immature technology can pose problems. Therefore it is critical that sponsors choose a contract research organization (CRO) with the specialized experience to foresee and forestall this new breed of potential issues.

Wearables: Drivers of DCTs—And Many of Their Headaches

From a CRO’s standpoint, decentralization is not revolutionary. Technologies used for electronic patient-reported outcome (ePRO) collection and electronic informed consent (eConsent), just to name a few, are longstanding facets of trial management, and other technologies have steadily gained broad-based acceptance and popularity. Further, as wearable technologies and home monitoring devices become standard accessories for the health-conscious, their data gathering in clinical trials seems increasingly natural.

These devices are also producing better results. The rising popularity of DCTs is based primarily on their ability to better support patients—saving them time and out-of-pocket costs while minimizing their exposure to outside pathogens. That increased support has led to improved compliance and better data, which are, after all, the holy grail of any trial.

Yet the sheer volume of data produced is one of the key challenges created by the surge in wearables. Data arrive day by day—sometimes minute by minute—often from multiple devices. Accurately collecting, managing, and analyzing all these data can be overwhelming. Yet, those processes are also critical to trial success—adding pressure to the task of choosing a CRO wisely.

How Accurate is That Avalanche of Data?

The ISR report reveals that the selection of apps, monitoring devices, and online platforms rests primarily with the sponsor. That makes sense since the ultimate responsibility for accuracy also remains with the sponsor. Current International Council for Harmonization (ICH) guidelines specify, “The sponsor should ensure oversight of any trial-related duties and functions carried out on its behalf, including trial-related duties and functions that are subcontracted to another party by the sponsors’ contracted CRO(s).” Yet, the CRO still bears day-to-day responsibility for the data.

The deluge of data not only needs to be managed, it also needs to be verified. After all, the patients responsible for much of the collection aren’t tech experts.

Some of this is business as usual for professionals at CROs. Just as they have ample experience utilizing technologies to alleviate paperwork and decentralize data input, they have been assimilating data from multiple sources through multiple systems for a long time. The issue now is one of scale: DCTs may produce 10 times the volume of data as a traditional trial.

As for patient control of data generation, the ISR report indicates that wearable sensors and connected health devices are the top hybrid trial-related areas in which sponsors invest significant resources; they are also the technology ISR respondents ranked as needing the most improvement, with user-friendliness deemed a key concern.

Many CROs are primed to address patient tech challenges, too. A core competency in developing a DCT is the ability to make it accessible in all ways to a range of patients; that includes helping and supporting patients in using the chosen trial technology.

Can Your CRO Handle a DCT? (How to Judge Before You Hire)

While many CROs are technology-savvy, not all are. Here are eight key areas to consider as you are choosing a CRO partner.

1. A track record of success. This may seem obvious, but it is not as straightforward as it may sound. Be sure to understand exactly how the CRO measures success—and what its role was in every aspect of a “successful” trial.

2. The overall approach to DCTs. Some CROs develop specialized personnel focused solely on DCTs; they may have different offices, different leadership, and different trial teams. This may seem preferable—a group of experts wholly focused on this new way of operating. We respectfully disagree. We see DCTs as a continuum of the traditional model, and advocate actively ensuring that all team members are well versed in what we believe will be the future of clinical trials.

3. Optimal protocol support. As sponsors prepare their trial, they should consider which aspects of the protocol can be decentralized; they can then discover whether the risk management and associated technology abilities of the CROs under review have evolved to support those key aspects.

4. The vendor management process. DCTs may require many more vendors than a traditional trial—and sponsors need assurance about data quality. How do the CROs vet the vendors? Can a CRO or its vendor access the right data, process that data, and perform risk management during the clinical trial? We have had sponsors request that we partner with a specific vendor, then found during the request for proposal process that the vendor would be unable to transfer the data without relying on a third party. By identifying these sorts of stumbling blocks in advance, we can circumvent them.

5. Flexibility and nimbleness. DCTs require partnership with a wide range of companies, some of which may not be precisely aligned in their approach to this evolving process. Does the CRO have a proven method for collaborative vendor management, proactively addressing risks and minimizing quality concerns while remaining collegial?

6. The breadth of in-house technologies available. One way to streamline third-party vendors is to partner with a CRO with several in-house technologies making them more of a one-stop-shop. Ideally, this would comprise a comprehensive data collection, management, and analysis system.

7. Transparency into data lineage. Assuming that a clinical trial is successful, at some point, the sponsor will need to show its data to various regulatory bodies. If regulators have questions, the ability to track and instantly retrieve each piece of data—along with records on how it was collected, queried, and stored—is invaluable.

8. Adoption support. Does the CRO have strategies in place not only to train and support patients on the various technologies, but also to train and support its own clinical trial team?

Data and the technology required to deliver those data accurately are core components of DCTs. By using these eight parameters, sponsors can ensure their CROs can effectively deploy the technology to deliver the necessary data—organized, analyzed, and verified.

DCTs: Delivering On the Future of Clinical Trials

There is no question that COVID-19 accelerated the adoption of DCTs. Previously, the change-averse healthcare industry had been moving slowly and ponderously in that direction; now, there is no going back. Patients prefer DCTs—a preference that has bolstered recruitment, retention, and even compliance. Technology has kept pace, adapting and advancing to support larger, more complex trials while allowing patients to reduce clinical visits. CROs, too, are growing more comfortable, either by creating freestanding DCT teams or developing company-wide expertise.

While there are many questions regarding best practices in DCT management, specifically ensuring data quality, our observations of how data and technology trends are stacking up against quality, utility, accessibility, and patient privacy metrics have cemented our belief that careful vendor management, flexibility, transparency, proactive adoption support, and a fully integrated team can deliver superior DCT results.