Faster Safety Reporting: AI qualitative analysis

According to the PLOS One study, 23 CTU staff participated in four focus groups (01-July-2024 to 04-March-2025) and reported that safety reporting is experienced as "walking on a tightrope" between over-reporting and under-reporting PLOS One.

• 23 participants across four focus groups were included in the analysis conducted between 01-July-2024 and 04-March-2025, reported in PLOS One on 30-Jul-2026.
• Participants had a mean of 13.3 years working in trials (SD 9.5), reported in PLOS One, indicating experienced staff nevertheless face uncertainty about safety-reporting decisions.
• The PLOS One authors link their findings to the UK regulatory change that came into force on 28-Apr-2026, which reduced duplicative reporting to RECs according to the MHRA and UK legislation.
• The PLOS One study recommended clearer regulator guidance, role-specific training, and CTU-level knowledge sharing platforms as practical next steps.

The PLOS One study found that trial staff balance risk-proportionate reporting against risk-aversion, creating inefficiency and uncertainty.

According to PLOS One, the study used four online focus groups conducted between 01-July-2024 and 04-March-2025 with 23 participants from 10 of 52 UK registered CTUs, and data were analysed using Reflexive Thematic Analysis PLOS One.

PLOS One reported a central theme, "Walking on a tightrope: Making justifiable decisions, " and five subthemes: (1) uncertainty about consequences, (2) bureaucratic red tape, (3) competing demands, (4) lack of clarity and transparency, and (5) variable experience and training.

"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, " said Participant 16 in the study (PLOS One).

"It feels difficult and there is always that element of anxiety that you’ve got it wrong, " said Participant 20 in PLOS One, which the authors link to conservative, time-consuming reporting practices that can obscure safety signals.

CTU managers should prioritise role-specific training, because the PLOS One study shows knowledge gaps and low confidence drive conservative reporting choices.

According to PLOS One, participants recommended shared templates, mentoring, and case studies to standardise practices and reduce duplication across sponsors and sites.

Regulatory alignment matters: the PLOS One authors link operational burden to inconsistent requirements across portals such as EudraVigilance and national forms, and note that the UK changes effective on 28-Apr-2026 reduce duplicate REC reporting (MHRA/legislation).

Embedding patient-reported outcome measures is recommended by ICH E6 (R3) 2025, and PLOS One highlights PROMs as one route to capture low‑grade toxicities that affect quality of life.

The PLOS One study documents how 23 UK CTU staff describe safety reporting as a tightrope between over-reporting and under-reporting, and it recommends clearer guidance, training, and sharing platforms to restore balance PLOS One.

AI qualitative analysis for safety reporting turns focus-group insights into auditable, regulator-ready evidence, shortening the time from transcription to action and addressing the PLOS One recommendations for shareable templates and training.

If you manage trial operations or lead a CTU, try a focused pilot: run one recent focus group or SAE review through an AI-assisted thematic pipeline and export a decision log to test with sponsors and sites.

To get started, Try Evidano for free and see how thematic analysis, transcription, and exportable audit trails can help you implement the pragmatic, risk-proportionate reporting practices the PLOS One study calls for.