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How to Navigate the Global DCT Landscape

Cassidi Williams

One of the benefits of running a decentralized clinical trial (DCT) is its scalability on a global level. Global adaptation of decentralized clinical trials allows sponsors and CROs to maximize operational efficiency, engage with a wide swath of participants and improve study outcomes. DCT models conducted in Europe, Asia, and Latin America can also reduce overall study costs. To realize all of these benefits requires flexibility in the model to successfully scale cross-nationally. That flexibility is rooted in a continual understanding of and adaptation to three distinct DCT landscapes.

  1. DCT Regulatory Landscape
    It’s fairly obvious that different nations oversee clinical research and trials under varying sets of regulations. However, the move to decentralized trials has brought these to the forefront as reviewers, auditors, and other governing bodies are expanding their own knowledge of this model at different rates. That means that two identical proposals for the same study submitted in two different areas might have very different approval outcomes, for no identifiable reason. It’s important for DCT providers to understand that each step of a decentralized clinical trial, from study approval to clinical deployment to post-study clean-up, is a potential area for divergent regulations country to country (and sometimes even region to region within a country). To mitigate potential regulatory challenges, pay close attention to areas of most push-back and concern globally: data gathering techniques and secure storage; transportation of clinical supplies; protecting patients’ rights and privacy; quality control; dispute settlement; and study validation.
  2. Decentralized Clinical Trial Implementation Landscape
    Similar to regulatory challenges, every step of DCT implementation can be affected on an implementation level. Without proper planning and operationalizing the trial, variation of trial implementation can lead to loss of value which may put findings at risk. Although there are critical roles for your entire team to navigate the global DCT landscape, particular groups can take a significant lead in this area. The financial and legal team that handles contracting should be well-versed in the target regions’ rules, requirements and approval timelines. To lessen the effects of study drug and material accessibility, your procurement team must have deep involvement in study implementation. Finally, implementing a global hybrid decentralized trial means hiring local personnel and training them effectively. Ensure your HR and learning functions have early and ongoing involvement in the process to mitigate staffing challenges that can hinder timely DCT progress.
  3. Diverse Cultural Landscape
    Underlying the above DCT landscapes are the ever-present cultural differences both among and within countries where virtual research projects are run. Areas that fall under “cultural” differences include lifestyle, overall wellness, technology adoption and availability, language, communication norms, trust of medical personnel and response to authority figures. These cultural differences should be acknowledged, incorporated into study design, and managed throughout the DCT to mitigate possible issues with study effectiveness and participant retention. Consider how to fit your study within cultural norms vs. expecting participants to alter their lives for the study. Diversity should be prized and is one reason a decentralized trial approach results in better research and outcomes.

Understanding factors that affect decentralized trials is critical to success. Learn more from four industry experts, including THREAD’s John Reites, about “What Does a Good DCT Look Like?” in our latest webinar.