DCTs create fresh privacy challenges for review boards. Now there are guidelines.

Decentralized clinical trials (DCTs) are finding a permanent place in the post-COVID world, largely due to their ability to improve convenience, enhance recruitment and promote trial diversity. But the institutional review boards (IRBs) and ethics committees (ECs) overseeing them are struggling to navigate the novel challenges they present.

Patients in DCTs are digitally tethered to research hubs from home or community locations using technology such as cell phones, sensors, tablets or video. While these devices can increase trial efficiency and reach, they also come with unfamiliar privacy and security concerns for IRBs and ECs.

“If you use a phone or a smartwatch, all of a sudden people can know a whole lot more about you than if you had just given them a piece of paper,” said Dr. Pamela Tenaerts, chief scientific officer at Medable, a decentralized clinical trials software company.

Other new considerations are putting more drag on the ethics review process, which is already historically criticized as cumbersome and slow, such as: If you download an app on your phone, does that app have access to your contacts? And does it track you using GPS?

Seeing the need for clarity and guidance, a group of industry stakeholders recently spent 18 months reviewing DCTs processes to create a toolkit for IRBs and ECs. The task force, which included representatives from the Multi-Regional Clinical Trials Center of Brigham and Women’s Hospital and Harvard (MRCT Center), Medable, the FDA, the Office for Human Research Protection (OHRP), ethics committees, sites, patients and patient advocates, created an oversight roadmap they hope will help clear review bottlenecks.

Understanding the differences

In many ways, DCT reviews are similar to traditional sites.

“The core ethical considerations that impact decentralized clinical trials (DCTs) are the same as the ones impacting traditional trials: data privacy, security and quality,” said Tenaerts. “With DCTs, they have a different salience though because the risks can be greater. For instance, a trial that leverages video conferencing is more vulnerable to privacy breaches simply because a patient may not have a private place to engage with trial teams.”

To determine where the risks are, the task force traced patient pathways to create a framework for board reviews. Each of the 13 sections in the toolkit introduces and defines a DCT element, such as eCOA. It provides guidelines and best practices for that element, a list of questions that board members should ask, and a documentation checklist.

“There is a concluding section, too, that provides a broader list of considerations across all DCT elements,” said Bierer.

New targets

The toolkit may ease headaches for sponsors and investigators struggling with frustrating inconsistencies in the DCT review process. To wrap their heads around new digital challenges, some IRBs and ECs request reams of detailed — and sometimes unnecessary — information.

“For instance, some IRBs only want to see the informed consent as a PDF, while others want to see every completed consent screen shot,” Bierer said.

Eliminating this variability can streamline the review process.

With the first toolkit complete, the task force is turning its attention to other DCT problem areas, such as the struggles principal investigators (PIs) face overseeing remote trial sites.

In May, the FDA issued long-awaited guidance that provided clarity over how the agency plans to review DCTs. But unanswered questions remain, including some related to how these PIs operate, such as whether an investigator needs to be licensed in each state where they are overseeing a trial. Having a framework in this area may help make the investigator’s job easier.

Overall, it’s clear that making the transition to DCTs is worthwhile, but there is a substantial learning curve left to navigate. The task force hopes to ease that process.

“Every time you switch systems, you need to have a new way of learning how to do things and that’s what we’re hoping to contribute,” Tenaerts said.