Planned and unplanned mid-study changes add an average of 30 days to clinical trial timelines, according to a new study by the Tufts Center for the Study of Drug Development (CSDD).1
The findings, based on data collected from 194 global drug developers, found that regardless of company size, each clinical trial has an average of four planned and four unplanned mid-study updates.
Further analysis found that larger companies take an average of 35 to 40 days to resume a trial after a mid-study change. Smaller companies reported delays closer to 25 days.
Ken Getz, professor, and director of Tufts CSDD who oversaw the study weighed in, “Sponsor companies are seeing an increase in mid-study updates as they implement more amendments, conduct more interim analyses, and execute more flexible and ambitious clinical trial designs.
The study demonstrates the challenge and impact of planned and unplanned updates and suggests an important opportunity to reduce clinical trial cycle times.”2
The report comes on the precipice of the clinical trials industry shifting to a post-pandemic mindset. As sponsors and CROs look to reclaim lost revenue due to delayed and disrupted trials last year, they are brainstorming ways to simplify, unify, and accelerate trial timelines.
Additional study results highlighted in the Tufts CSDD Impact Report include the following:
- Companies reported 4.1 planned and 3.7 unplanned mid-study changes per trial on average.
- Planned mid-study changes took 1.5 fewer days to go live again, compared to unplanned changes.
- Approximately one-third of companies reported that database delays, lack of integrated eClinical suites, and solution costs were major pain points during mid-study changes.
- Survey respondents who identified as “more satisfied” with their EDC’s ability to manage mid-study changes reported a five-day advantage in resuming their trials.
Delays due to planned and unplanned mid-study updates were the most frequently reported pain points by approximately half of respondents. Experts believe the abundance of delays stems from increased complexity in trial workflows, combined with disparate systems that delay real-time data transfers and insights.
Getz cited Operation Warp Speed as a leading example of what can happen when trials decrease complexity and increase trial speed through unified measures.
He noted that they were able to achieve a 75 to 80% reduction in traditional clinical testing timelines, but the industry is still waiting to see which changes will persist in a post-pandemic world.
“There’s a lot of resistance to seeing a lot of this translate into ongoing long-term behavior,” says Getz.3
The industry must gravitate towards greater adoption of integrated decentralized solutions, paired with patient-centric workflows that involve the patient perspective in trial design early on.
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Sources
- Tufts Center for the Study of Drug Development, March/April 2021 Impact Report, Analysis & Insight Into Critical Drug Development Issues, Volume 21, Number 2
- Mid-Study Updates Delay Trials at least a Month, CSDD Report Finds
- Mid-Study Updates Pose Major Challenge to Clinical Trial Timelines
