Trial by Fire: Lessons Learned on the Challenges of Decentralized Trials

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The clinical trial industry has been rapidly transforming from site-based traditional approaches to technology-enabled decentralized processes over the last couple of years. The COVID-19 global pandemic has only fuelled a fire that was already kindled by ballooning costs, high patient burden and patient attrition. Necessity is the mother of invention, and we as an industry have been forced to adapt.

 

Decentralized Trials (DCTs) are now shifting into focus as the preferred method for conducting research. Estimates from leadership within Pharma are that 60% of clinical trials will have virtual trial elements by 2022. However, moving to a DCT is not a panacea for cost-effective or patient-centric research. In fact, many researchers and sponsors are encountering new challenges. This post will cover some of the most common problems encountered by teams who are newly-adopting DCTs, so you can be better prepared to execute effectively.

 

  • Technology should lead, not follow
    When technology gets introduced as an afterthought after the protocol is finalized, technologists are often brought in to execute, instead of being active participants in the overall trial design process. This results in awkward trial procedures where the technology cannot readily conform to the process that was idealized in the protocol. Bringing DCT trial platform technologies into the picture from the beginning can avoid inefficient protocol redesign or attrition from frustrated participants.

 

  • Onboarding can make or break engagement
    Many DCTs rely on Apps, websites, and technologies to inform participants about the trial, screen appropriately, consent, and set expectations about trial participation. The problem is that even when carefully designed and selected these digital experiences may end up being unclear, unfriendly, or too complicated for participants. Let’s face it: DCT trial tools are digital experiences which are competing with well-designed apps, social media, and games for participants’ attention and their expectations for usability. In a trial that utilizes technology, a smooth, clear and well-designed onboarding experience is the difference between an engaged participant and one who abandons before consent.

 

  • Technology is not one-size-fits-all
    Out-of-the-box software necessarily comes with some constraints for use, but the truth is that participants’ experiences with trial technology are going to vary dramatically based on a number of factors, including demographics, education, income and tech literacy. Trial procedures should offer some flexibility when possible. For example, consent may have to be designed to accommodate individuals with differing needs, such as using media, offering teleconsent, e-signature, or with a standard “print and sign.”

 

  • Digital endpoints should consider user experience
    With DCTs, clinical trials are now collecting primary and secondary endpoints digitally using ePRO and digital biomarkers from sensors. But these tools and methods are not always patient-centric or user friendly. Digitization of validated questionnaires in an electronic format should take into consideration form factor, device type, and ease of use while not negatively affecting validation of the instrument itself. Lengthy surveys will bore and fatigue patients, so use of ePRO requires researchers to prioritize outcomes and get quality over quantity. Some sensors can also be uncomfortable to use or wear, or have complicated instructions, leading to poor engagement. Thus, researchers should focus on human factors.

 

  • Fractured technology can cause discoordinated datasets
    DCTs often end up with different vendors selected for different trial purposes from telemedicine, to call centers, to automated drug delivery vendors to home health services. When data generated through services are not designed to integrate into a central data hub, each vendor holds a discrete dataset for their service component. Ultimately, a single study dataset will have to be stitched together (either at the point of interim analysis or at the end of the study) but by then it is too late to address gaps and missing data. CROs and sponsors need to ask whether DCT trial technologies allow for real-time data integration, and provide visibility of end-to-end trial components and services to ensure the highest quality dataset possible.

 

  • Technology is not always the answer
    A study run mainly on technology solutions may feel depersonalized and patients may miss the human touch they recieve with site-based trials. Especially when studies require the use of new technologies and devices, patients may need technical support or may have study-related questions. Without this support, they may discontinue or engage in the trial inconsistently. Having a study concierge who acts as a single point of contact and can provide on-demand support to the patient is critically important to keeping participants engaged. Offering options for patients to complete activities either remotely or with the support of a study team member (at a site, or on call) can help re-engage patients overwhelmed by or disinterested in technology.

 

Have you been experiencing similar trials in your DCT experience? We would love to hear more about your challenges, solutions and needs. Feel free to contact us for a discussion on how we can help you optimize your DCTs.

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