Lesson Learned from COVID-19 Vaccine Trials
A CRO perspective on accelerating clinical development
Institute Report
Apr 28, 2022

Web Summary

The COVID-19 viral pandemic has led to more than 500 million infections and 6.2 million deaths worldwide by mid-April 2022 and has been one of the top three causes of death in the United States since March 2020. The unprecedented modern-day global need for rapid development of effective vaccine and therapeutic solutions was met by a massive and coordinated response across critical health system stakeholders and led to the development of COVID-19 vaccines in well under a year — timelines previously unheard of in vaccine clinical development.

The research behind this report explores model changes that allowed for clinical trial efficiencies from the perspective of the CRO and is based on a set of workshops with COVID-19 vaccine clinical delivery teams. Our emphasis is on understanding what was possible because of the drastic operating environment changes and assessing what can be carried forward into the post-pandemic clinical development pipeline of therapies for other illnesses.

Key findings

  • COVID-19 vaccines were available for public use in seven months from the start of clinical trials in a record-breaking, cross-stakeholder response to the urgent, unmet need driven by rapidly spreading unchecked viral infections.
  • Environmental enablers, including more than $20Bn in public-private funding, regulatory authority focus, and historic investigator and subject interest in trial participation were critical in delivering these vaccines, thanks to a shifted risk-return balance.
  • A CRO explicit analysis of the operational drivers of trial-specific time savings showed pivotal trials led to an EUA filing with a 26-month, or 70%, savings versus historic trials as a result of operational improvements, organizational responses, and clinical development model improvements.
  • Process improvements driven by innovation and resource focus in contracting, start-up, recruiting and database lock were supported by intensive team, governance, and leadership focus. All of the operational and organizational changes could be tracked back to a blended shift in process redesign, resource utilization, decision-making practices, and partnership behaviors.
  • ROI analysis highlights a set of changes that are high efficiencies with potential to drive value going forward if implemented beyond vaccine trials, and a second set that is more investment intensive, but includes important drivers of speed for consideration on larger scale or highly time-sensitive trials.

Other Findings

  • Focus on individual COVID-19 vaccine pivotal trial (Phase II and Phase III) timelines to better understand operational time savings revealed that each stage of trial execution, including contracting, study start-up, enrollment, treatment, and database lock and analysis had pandemic-era specific challenges and opportunities to streamline delivery of clinically proven COVID-19 vaccines.
  • Characterization of how the COVID-19 vaccine trial level changes were achieved surfaced more than 20 critical and impactful changes that can be organized into a nested framework of operational actions, organizational alignment, and model drivers.
  • Operational actions were the specific process innovations, streamlining and shifts in resource utilization that led to in-trial efficiencies; these actions were spread across the trial process and included more than 12 critical changes.
  • Organizational alignment includes implementation of focused organizational constructs including optimized leadership-engagement, sponsor and CRO governance, team working structures, and quality and process management mechanisms to best support operational changes.
  • Model drivers include fundamental behavioral, structural, and strategic business foundations such as partnerships, decision-making processes, process innovation, and resource optimization that were shifted in the context of the pandemic and allowed for all the cross-trial organizational and operational changes.
  • Analysis of these change drivers in the context of pipeline composition can help guide ongoing change implementation to situations likely to yield positive ROI, with most being applicable to large scale, acute-care trials, and some of the higher efficiency changes likely to drive value in specialty care trials.
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