Authors: Jen Davis, Deputy General Counsel & Chief Privacy Officer and Silvia Chia, Senior Director Regulatory Affairs

Studies with Decentralized Clinical Trial (DCT) elements must be fit-for-purpose—and designed to protect patient safety, privacy, and rights

The European Medicines Agency last month published a recommendation paper for using decentralized clinical trial (DCT) elements in support of regulatory submissions. The “Recommendation Paper on Decentralized Elements in Clinical Trials” is part of the Accelerating Clinical Trials in the European Union (ACT EU) initiative, and the paper includes broad perspectives from European regulators as well as from patient and health care professional representatives.

For sponsors and research organizations looking to conduct studies in the European Union with DCT elements, the paper provides recommendations for study design, conduct, and oversight, and should help create better understanding and alignment among clinical trial sponsors, patients and regulators. Based on our extensive experience conducting fully decentralized and hybrid clinical trials, our key takeaways from these new recommendations are as follows:

1. First, do no harm. The agency's overarching goal is to ensure that studies that include DCT elements pose no additional risk to participant safety, rights, and well-being. The paper notes that these “should be protected and prevail over all other interests,” and further encourages sponsors to engage with potential participants, patient organizations, investigators, and healthcare professionals on the design, development, and implementation of studies.
    
2. Utilize DCT elements when they’re fit for purpose. The recommendations paper makes clear that regulators want sponsors to consider the potential risks of utilizing DCT elements to ensure that the approach is the right fit. Variables such as trial population, the disease, the type of assessment, and the risk/benefit profile of the investigational product all influence the appropriateness of including decentralized elements. As such, the agency emphasizes flexibility in study design to account for any number of contingencies should a participant prefer certain activities to be conducted in a more traditional manner (i.e.: to visit the research site, or leverage paper consent instead of electronic consent).
    
3. Have the plan to ensure data integrity and mitigate risk. If any DCT element is likely to have a significant impact on scientific validity, data integrity, benefit-risk ratio or impact on the protection rights, regulators would like to see these concerns spelled out in a specific and documented risk-benefit assessment which includes clearly described mitigation strategies.
    
4. Crystal clear oversight. Regulators are also wanting to see clearly defined oversight and responsibilities for clinical studies containing DCT elements. The agency notes valid concerns about appropriate oversight, participant rights, integrity of data, and so on, and encourages sponsors to develop very clear plans to make sure those key issues are accounted for—and by whom—before a study begins.

Although there’s certainly plenty more to unpack in the agency’s first published recommendations for decentralized clinical trial solutions (outside of pandemic-inspired guidance), the primary thrust is that while there’s a keen recognition on the potential and benefits that decentralized trials bring to clinical research, these solutions must be leveraged correctly. 

At Science 37, our extensive expertise helps pharmaceutical sponsors navigate the implementation of decentralized and hybrid clinical trials (such as the Science 37 Metasite). Some pharmaceutical sponsors still see decentralized clinical trials as new, leading to hesitation to implement virtual forms of clinical trial conduct. These recommendations help further the conversation of how, when and for what purpose sponsors consider incorporating DCT elements into clinical studies. At Science 37, we continue to see the benefits that the Metasite brings to sponsors and patients alike, from improved clinical trial access and equity, to faster trial startup and a more patient-centric experience.  

To learn more about the benefits of the Science 37 Metasite, visit www.science37.com/metasite.