Squaring regulatory issues in decentralized clinical trials

Alison Shurell
Global Head of Marketing

As decentralized clinical trials become more commonplace, due to the accelerated adoption in response to the environment created by the global pandemic, trial professionals are taking a close look at a number of challenges. One that’s near the top of the list is aligning the changes that come with decentralized clinical trials with regulatory requirements, according to a recent survey of clinical research professionals conducted by Informa Engage on behalf of Oracle.

There is particular concern with the introduction of wearable devices and remote monitoring technologies, two key components of decentralized clinical trials. Of the 252 respondents in the survey, 42% said there are “complicated regulatory considerations” involved in those efforts. Further complicating the adoption for nearly half the respondents: What they see as unclear regulatory guidance, leaving them uncertain about how to adopt various elements of decentralized clinical trials without possibly running afoul of agencies or even having to start a trial over because of a regulatory misstep.

Regulatory catch up

Many regulatory agencies are just beginning to undertake the work needed to update their rules and processes to account for the shift to decentralized clinical trials. While many of these agencies support decentralized clinical trials from a policy perspective, the devil is in the details, says James Streeter, Oracle’s global vice president, life sciences product strategy.

“Things just aren’t aligned yet,” he says. “Regulatory agencies, at a high level, want companies to move to decentralized trials” because it can both streamline trials and make it easier to enroll a diverse set of patients. Yet, existing regulations remain in place that can make it difficult to actually design and run a decentralized clinical trial, and newer ones haven’t been written or implemented yet, meaning “there are a lot of murky waters.”

Challenges with Compliance

Even for companies who believe the regulations are clear, complying with them is not as easy as it might seem, as the survey revealed:

  • Challenges with training, monitoring, and ensuring compliance with new data collection methods is a concern for 39% of the respondents
  • Almost as many, 37%, say regulatory guidance can create difficulty when it comes to maintaining quality and integrity of the study
  • Three in ten say complying with regulatory guidance can hinder the speed at which they can introduce changes to trial protocols, potentially disrupting the study
  • More than a quarter worry about keeping up-to-date with frequently changing guidelines from regulators

Tellingly, only 12% of the respondents said they have experienced no difficulties in complying with regulations around decentralized clinical trials.

Because so much of the concern revolves around data, it makes sense for companies to manage trials with an integrated platform that provides a single repository for data and a common view into that data. Such an environment can help companies better manage data collection, maintain the integrity of that data, and streamline the presentation of the data to regulators – even potentially allowing regulators to examine the data online rather than via massive filings.

“This really affects a lot of companies from a process point of view and what they have to do to bring all these regulatory issues together,” Streeter notes.

As sponsors increasingly shift to decentralized clinical trial methods, the industry – sponsors, CRO, sites, and regulators – will have to work together to ensure everyone is clear on how to do it in a compliant manner that ensure data quality and control.

You can find more details of the survey results by downloading the research report.

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