A CRO perspective on accelerating clinical development
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 – Lessons Learned from COVID-19 Vaccine Trials – 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.
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.
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