Post Clinical Trials & Research February 16, 2023 Common myths about decentralized clinical trials Traditional clinical trial models are oriented around a study site, requiring participants to travel to the clinic to provide data. Decentralized clinical trials (DCTs) are a newer study model that uses digital technology to enhance all stages of a trial from recruitment and enrollment through engagement, retention, and data collection, with capabilities only possible outside the confines of a clinic. A decentralized study model offers a number of benefits, including an improved participant experience, but clinical trial sponsors and researchers have been slow to adopt this model. Here we address five of the most common misunderstandings about DCTs that have contributed to this lack of adoption. Myth 1: All study components are decentralized The term decentralized clinical trial can imply that the entirety of a study protocol is digitized and moved out of the clinic. However, DCTs are simply defined as studies that involve digital data acquisition outside of a research site, and not studies that collect all data virtually. Many trials that currently use DCT technology employ a hybrid trial model that provides participants more optionality and thereby potentially increases engagement and compliance. In much the same way that digitization is more than just moving paper-based processes into computers, DCT technology and digitization enables different elements of a protocol to be optimized to best suit the study aims and increase potential pools for recruitment while maintaining engagement. This provides more options to meet the participant in ways which are both efficient for the study and the participant. This gives the study team the opportunity to choose options that would not have been possible due to geographic or physical limitations. With the optionality enabled by DCT technology and digitization, in-person data collection can be accompanied by study tasks where the participant is able to choose how they prefer to complete them. Surveys, or participant-reported outcomes, for example, could be completed remotely, at the participant’s convenience, or in the presence of a study coordinator during an in-person visit. Similarly, blood or saliva samples might be collected in the clinic or through a Quest location or at-home kit. These options enable participants that live under a much wider range of situations and constraints to participate. Ultimately, DCT technology enables better engagement and more reliable data collection with the participant experience in mind. Myth 2: Virtual recruitment is less effective A common misconception about DCTs is that recruitment is too difficult without having an established in-person relationship with a patient population. Instead, recruitment can be enhanced by enabling a larger population to engage for potential enrollment by removing geographic barriers to participation. This recruitment is further enhanced by expanded recruitment channel options including social media, QR codes, websites, emails, and more. By allowing in-person and remote engagement, participants may discover clinical trials on their own rather than solely relying on clinicians to refer patients to relevant upcoming trials. This further enhances trials by expanding the range of outreach and, therefore, participant populations can be more diverse. Ultimately, this means DCT technology can reach more individuals and lead to more generalizable study results while using the best in person and remote methods to find and retain participants. Myth 3: DCTs exacerbate the digital divide When considering incorporating DCT technology in a clinical research setting, a common concern is introducing biases derived from requiring the use of a mobile phone or other device with internet access. Recent analyses, though, indicate that the digital divide has narrowed within the United States and underrepresented populations—sexual and gender minorities (SGM), ethnic/racial minorities, females, and other underrepresented or underserved populations—make good candidates for participating in digital clinical studies. For example, 85% of SGM people use social media in some capacity and 91% of people with a physical or mental disability use a smartphone or tablet. Despite the narrowing digital divide, clinical trials that use DCT technology do not only rely on strategies that require effective use of personal mobile devices. Importantly, DCT technology does not exclude traditional methods of executing study protocols. Data collection can still be done in person for those that don’t have access to technology or demonstrate low digital literacy. DCT technology expands the methods for any participant to provide data and engage effectively in a study. Myth 4: Digital, eConsent models reduce study comprehension Participants are generally able to understand common components of clinical trials (e.g., voluntary participation, freedom to withdraw at any time) through traditional long-form consent documents. However, many participants still struggle to understand the concept of a placebo, randomization, risks, and potential side effects. This lack of comprehension can impact recruitment, study adherence, and retention rates. A common misconception with DCTs is that participants’ understanding of a study will further decrease with digital, eConsent models—where a study coordinator is not walking the participant through the consent in person. However, DCT technology can enhance consent forms in a manner that may improve study comprehension. Through technology, clinical trial consent can be enhanced through multimedia content and ease of presenting the information in a participant’s preferred language. Multimedia content has been shown to increase participant understanding of trial details. As participant learning styles may vary, it can be helpful to supplement long-form consents with this multimedia content. Technology also allows for easy presentation of consent information in a language that the participant may understand better. Additionally, comprehension can be assessed and improved by targeted questionnaires that confirm understanding and potentially provide more resources to fill in identified gaps. Ultimately, if targeted populations or groups of participants still need one-on-one discussion with a study coordinator, it can be more focused on the specific individual’s needs. Myth 5: DCTs add burden to study sites and participants DCT technology introduces change to study sites which brings with it a natural concern around new burdens and complexity. However, a well-implemented DCT focuses on how to remove the burdens associated with mandatory on-premise activities for both participants and coordinators while improving the manageability of these tasks in a virtual setting. For study sites, DCT technology shifts work from the clinic setting to a convenient time in the participant’s day, making interactions more convenient for the participant. Not only is this time more convenient but often information is requested closer to an important event and the burden associated with recall is also decreased. As long as this increased convenience is not offset by requesting more data, participants often prefer this method of interaction. In addition to increased participant convenience, DCTs often require less time from the study coordinators as a number of assessments no longer require direct engagement. To achieve this benefit, some upfront planning is necessary to design the participant-facing interfaces, notifications, and reminders. These features keep the participants on track with completing consents, assessments, and surveys with minimal coordinator prompting. Time saved in coordinating assessments and reminding participants of upcoming tasks and visits to maintain compliance can be focused on high impact engagement for targeted participants with unique needs. Throughout clinical studies, study teams can see higher compliance and adherence rates with less time and effort through automated notifications and reminders, as well as participant dashboards and reward systems that enhance trial engagement. Ready to decentralize your next clinical trial? 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