Faster Insights: Qualitative Analysis of Safety Reporting

Thompson et al., PLOS One (2026) found that UK academic trials unit staff described an overarching theme of "Walking on a tightrope: Making justifiable decisions" when enacting risk-proportionate safety reporting, and they recommended clearer guidance, shared learning and role‑specific training. Read the full study in PLOS One.

• Thompson et al., PLOS One (2026) ran four online focus groups between 01-July-2024 and 04-March-2025 with 23 participants from 10 of 52 UK registered CTUs.
• Thompson et al., PLOS One (2026) report a mean participant experience of 13.3 years (SD 9.5) and that phase II (N = 10) and phase III (N = 11) trials were most common among respondents.
• Thompson et al., PLOS One (2026) note regulatory reform came into force on 28-Apr-2026, which the authors expect will reduce duplicative reporting for SUSARs and annual safety reports.
• Key actionable solutions from Thompson et al., PLOS One (2026) were: clearer regulator guidance, CTU-level mentoring and shared templates, and concise, role-specific training materials.

Thompson et al., PLOS One (2026) used reflexive thematic analysis of verbatim focus-group transcripts to identify barriers and solutions to safety reporting efficiency in UK academic CTUs.

Thompson et al., PLOS One (2026) recruited 23 participants across four online focus groups conducted between 01-July-2024 and 04-March-2025 and analysed transcripts with NVivo v11.7, as described in their Methods section.

Thompson et al., PLOS One (2026) generated one overarching theme and five subthemes: uncertainty about consequences, bureaucratic red-tape, competing demands, lack of clarity/transparency, and variable knowledge/experience.

The study captured specific quotes that illustrate the decision tension, for example Participant 16 stating, "Generally, you’ve got to balance what you need to collect in terms of safety reporting and in terms of what’s needed to monitor the safety of the drug" (Thompson et al., PLOS One, 2026).

CTU researchers should prioritise building concise, role-specific evidence packages and shared templates because Thompson et al., PLOS One (2026) identify lack of clarity and inconsistent SOPs as a primary barrier to risk-proportionate reporting.

CTU operational leads should adopt mentoring and knowledge‑sharing platforms because Thompson et al., PLOS One (2026) report that participants recommended CTU-level mentoring and shared case studies to increase confidence and reduce over-reporting.

CTU trial managers should align early with Sponsors and sites to agree reporting parameters because Thompson et al., PLOS One (2026) found that competing stakeholder requirements drive duplication and inefficiency.

For audit and regulator dialogue, teams should produce extractable thematic summaries and exemplar decisions because Thompson et al., PLOS One (2026) show that perceived regulatory ambiguity increases risk‑averse behaviour.

Thompson et al., PLOS One (2026) show that experienced CTU staff balance a difficult trade-off between over- and under-reporting and that clarity, training, and shared examples are required to implement risk-proportionate reporting.

AI-enabled qualitative analysis can convert focus-group transcripts and SOPs into reproducible themes, extractable quotes and audit-ready rationales to support those changes.

If your CTU needs faster synthesis, searchable case libraries and secure transcription to implement the study’s recommendations, Try Evidano for free to pilot thematic analysis and AI chat over your safety reporting documents.