A survey of more than 50 senior pharmaceutical and biotechnology executives has found that 88% of sponsors face delays of at least five weeks in critical clinical trial reporting and statistical programming activities.

Clinical trial workflows face multi-week delays

The survey, commissioned by clinical development technology company PhaseV, examined timelines, spending and vendor use across clinical trial data workflows.

More than half of respondents, 51%, said pre-trial activities including study synopses, protocols, schedules of assessments and case report forms typically take five to eight weeks.

Delays were also reported during later stages of trial reporting. One-third of respondents said developing statistical analysis plans, SDTM and ADaM datasets, tables, listings and figures, and clinical study reports takes nine to 12 weeks.

A further 43% said these activities typically take five to eight weeks.

The findings suggest that clinical development teams can face prolonged data and reporting workflows before trial results can progress towards regulatory submission.

The survey also found that sponsors reported an average of four protocol amendments during a typical Phase 2 or Phase 3 trial.

Protocol amendments can require changes to study documentation, data systems and operational processes, adding further work to already complex clinical development programmes.

Multiple vendors add to data handoffs

Vendor fragmentation was another issue identified by respondents.

The survey found that 76% of sponsors use up to three vendors per trial across the workflows covered, while 12% use four to five vendors.

The use of multiple suppliers can create additional handoffs between teams responsible for protocol development, statistical programming, data preparation and regulatory reporting.

Among large biotech and pharmaceutical companies, median post-trial workflow spending was reported to increase from approximately $250,000 in Phase 1 to $900,000 in Phase 3.

PhaseV said the findings indicate that sponsors remain reliant on fragmented workflows as pressure increases to improve research and development efficiency and reduce clinical development costs.

The survey, titled The State of Clinical Trial Data Handoffs: Spend, Timelines, and Vendor Dynamics, gathered responses from more than 50 senior executives working in clinical operations, biostatistics, statistical programming and regulatory affairs at pharmaceutical and biotechnology companies.

AI could target fragmented workflows

The findings come as pharmaceutical companies increasingly explore artificial intelligence and automation for clinical development activities.

PhaseV said its AI Conductor platform is designed to automate parts of the clinical development workflow, including protocol development, statistical analysis and preparation of regulatory submission materials.

The company said its technology uses artificial intelligence and machine learning to generate clinical trial documents and statistical programming outputs while maintaining consistency between related materials.

However, the survey results do not establish that AI automation would eliminate the delays reported by respondents.

Raviv Pryluk, CEO and co-founder of PhaseV, said: “When late-stage reporting can stretch to three months and teams are stuck juggling multiple vendors just to cross the finish line, the clinical development model is clearly broken.”

The survey highlights the potential operational impact of delays in clinical trial data workflows, particularly as programmes move into later-stage development and the volume of documentation and analysis increases.

For sponsors, reducing duplicated work and improving connections between clinical trial data, statistical analysis and regulatory documentation could provide opportunities to shorten development timelines and reduce operational costs.