In a survey conducted by Informa Pharma Intelligence on behalf of Oracle Health Sciences, 76 percent of respondents indicated that the pandemic hastened their adoption of decentralized clinical trial (DCT) approaches. While the shift to DCTs is well underway, concerns remain around patient monitoring and engagement and data reliability and quality. In particular, nearly half of the survey respondents indicated that the current regulatory guidance surrounding DCTs and data collection is not clear1.
In January, the FDA updated its guidance on Conduct of Clinical Trials of Medical Products During the COVID-19 Public Health Emergency with an expanded appendix of questions and answers to help clarify expectations and best practices. Likewise, the European Medicines Agency released the fourth version of its own COVID-19 guidance in February.
Regulators continue to emphasize that patient safety is paramount and that, while data collection methods may change, the standards for data reliability, quality, and integrity remain the same. What remains unknown, however, is how regulatory practices that have been implemented out of necessity will become part of the post-public health emergency normal.
At Premier Research, we have extensive experience helping our partners navigate the evolving regulatory landscape – both before and during the pandemic – as well as managing what’s to come. In this blog post, we discuss three takeaways from our experience designing and implementing DCTs to help protect patient safety and preserve data quality:
- Consider the needs and expectations of all stakeholders. In the transition to DCTs, you as a sponsor may be concerned about maintaining visibility and control. Patients might appreciate the flexibility of off-site visits but have mixed feelings about the perceived level of care they are receiving and the overall trial experience. For sites, implementation of DCT approaches necessitates a shift in mindset and sometimes even roles as they move from traditional processes to decentralized processes that might require different skills. DCT study designs should consider how the needs and expectations of all stakeholders can be addressed while maintaining patient safety and data quality.
- Understand the opportunities and limitations of technology. DCTs often rely on a range of digital technologies to collect safety and efficacy data from study participants. These technologies add layers of complexity to the planning and processes required to ensure data quality. While apps, ePROs, and wearable devices may provide real-time data, increase patient convenience, decrease site burden, and reduce the need for source data verification, they also increase the volume of inputs and the challenge of managing it all. In addition to qualifying both the technology providers and the technologies themselves, you will also need to adopt policies, standard operating procedures, and training for reviewing, managing, standardizing and interpreting the data gathered.
- Ensure appropriate processes and training to support the shift to a decentralized approach. DCTs come with a learning curve for sponsors, sites, project teams, patients, and caregivers. The shift to the use of alternative data sources can be challenging, even for experienced study staff. Managing this change with clear processes and robust training can help to ease the transition and increase confidence in implementing decentralized approaches.
Pandemic-related disruptions have created a proving ground for DCTs. The FDA and EMA have demonstrated a willingness to work with sponsors on developing study designs, but there is very little concrete guidance. One approach to consider is incrementally introducing DCT concepts in a hybrid model that mixes on-site visits with remote visits, enabling the behavior changes needed to successfully execute more flexible but scientifically rigorous studies.
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[1] Oracle. Survey: COVID-19 the Tipping Point for Decentralized Clinical Trials, November 18, 2020. Available at https://www.oracle.com/news/announcement/covid-19-the-tipping-point-decentralized-clinical-trials-111820.html. Accessed April 15, 2021.