When the pandemic hit, many biopharma clinical trials across the world quickly slowed or were suspended particularly as many trial monitoring sites could not operate remotely. According to Genetic Engineering & Biotechnology News, more than 1,000 non-COVID-related clinical trials were disrupted worldwide at the height of the pandemic. Some study sites were forced to close, while some programs were backburnered as resources were shifted from lower-priority therapeutic areas.

As the pace of biopharma trials and R&D operations shifted and slowed, biopharma companies began to evaluate the situation and examine opportunities to adjust their processes and drive further efficiencies. Customer practices and other processes were suddenly challenged. COVID-19 accelerated the modernization of clinical trial processes. Key trends include the following:

  • Virtual or hybrid trials characterized by increased remote patient enrollment, remote patient diagnostics and monitoring, and trials which combine in-person and virtual visits.
  • Next-generation clinical operations tools, incorporating e-clinical assessments, e-consent processes, and remote monitoring capabilities.
  • Increased diversity among clinical trial participants, as a result of leveraging digital and other technologies to help facilitate participation by patients across a wider spectrum of demographics and geographies.

The results have included improved R&D efficiencies, acceleration of development timelines, and improved patient involvement and recruitment. Data analytics and consulting firm GlobalData reports that remote patient monitoring is expected to have the single greatest impact on the pharmaceutical industry in 2021.

These clinical trial processes have enabled regulators to work more closely with industry during trial processes rather than rely solely on clinical endpoint reviews. According to the 2020 Industrial R&D Investment Scoreboard worldwide report published by the European Commission, the pharmaceutical and biotech industry expends more than 15% of its net sales on R&D, the highest percentage level of R&D spend across all industry sectors worldwide. The modernization of clinical trials is expected to have a pronounced impact on biopharma R&D in years ahead.