With the onset of COVID-19, sponsors and CROs are actively looking for ways to continue non-COVID-19 trials that have been left in a standstill due to shelter-in-place and local lockdown enforcements. The modern and highly regulated clinical trial industry has never faced a pandemic of this magnitude, and trial continuation is critical when patients’ lives are in the balance.
The FDA has approved and encouraged the use of eSource since 2013, but some were still resistant to adopting virtual protocols. “I foresee COVID-19 being the catalyst to following the FDA guidelines on decentralized and virtual trials. Just doing the status quo is no longer going to be acceptable. Sponsors who were once resistant or hesitant to utilizing remote monitoring or eSource will be moving into doing so as a direct result of COVID-19,” said Brady Gilje, Sr. Data Manager at Trialrunners.
“I foresee COVID-19 being the catalyst to following the FDA guidelines on decentralized and virtual trials.”
In the 2013 Guidance, the FDA said that capturing source data electronically into the eCRF should eliminate unnecessary duplication of data, reduce transcription errors, facilitate remote monitoring of data, promote real-time access for data review, and facilitate the collection of accurate and complete data. So why the hesitation? Some sponsors found the upfront costs to be too great, even though moving to eSource has proven to reduce overall study costs. For many, paper-based studies were more comfortable – it’s what they’ve always done and it worked, so why change?
“I’ve never grown when I was comfortable. You learn when you’re uncomfortable. It’s time for sponsors to rethink study designs and data collection strategies. A lot of studies are on ‘pause’ right now, not discontinued, but they have to take a moment to think about a path forward. Moving to a virtual trial is a large discussion, but at the very least, we have to consider moving to a hybrid model utilizing eSource,” explained Tanay du Plessis, Vice President, Data Strategies & Solutions, Bioforum the Data Masters.
Some trials may be able to continue on a hybrid in-clinic/remote approach. For those trials, the ePRO Consortium recently released a COVID-19 Risk Assessment and Mitigation Strategies report that you can access here. This report outlines that patient safety should never be compromised and gives guidance on how to continue to collect PRO data originally intended to be collected electronically from in-person visits at study sites. Additionally, as part of the decision tree, it’s recommended to have a web backup solution. Medrio offers a cost-effective and quick configuration web backup in less than 4 weeks.
From the patient perspective, decentralization is preferred. Removing patient burden has proven to increase engagement and provide cleaner and more consistent data while maintaining compliance. ePRO and eConsent are two popular tools that achieve these goals. The accessibility of technology has increased patient expectations, and as such, allowing patients to use their own devices (BYOD) is another key element in the decentralization of clinical trials.
Pandemic aside, decentralized trials have shown improvements in patient recruitment and retention, accelerated study timelines, and reduced overall study cost. If you are looking for a way to continue your clinical trials, a combination of EDC, eSource, ePRO, and eConsent can keep your trial moving forward, while maintaining patient engagement and compliance.
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