By Nach Davé, Kristi Miller and Stacy Weil
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.