Patient Safety in Early-Phase Research: More Than a Checklist

World Patient Safety Day provides an opportunity to reflect on what patient safety means across healthcare and clinical research. Working as a physician in a Phase I clinical research unit and as a member of an HRA Research Ethics Committee, I see patient safety from two different but complementary perspectives.

In early-phase research, safety is at the centre of almost every decision. Participants may be exposed to an investigational medicine for the first time, or to medicines for which the clinical safety profile is still developing. Protocol eligibility criteria, dose-escalation rules, stopping criteria, laboratory monitoring and adverse-event reporting all provide essential safeguards. But patient safety cannot be reduced to following these processes correctly.

It also depends on clinical judgement.

A laboratory abnormality, a new symptom, or a change in vital signs may appear relatively insignificant in isolation. Recognising when it represents an emerging safety signal requires clinicians and multidisciplinary teams to look beyond individual data points, consider trends and context, and escalate concerns appropriately. Creating an environment in which team members feel able to question decisions and raise concerns is therefore an important part of a strong safety culture.

My work with a Research Ethics Committee has reinforced another aspect of safety: protecting participants begins long before the first dose is administered. Ethical review considers whether risks have been appropriately identified and minimised, whether the scientific question justifies those risks, and whether potential participants are given clear and understandable information on which to base their decision.

This is particularly important when considering equality, diversity and inclusion. Information may technically be available without being genuinely accessible. Language, health literacy, disability, cultural differences and individual circumstances can all influence whether someone can understand research information, communicate their concerns, and participate meaningfully in decisions about their care or research participation. Inclusive research practice is therefore not separate from patient safety; it is part of it.

Perhaps the most important reminder is that participants themselves are partners in safety. They are often the first to notice a new symptom or change in how they feel. Listening carefully, taking any concerns seriously, and ensuring participants know when and how to seek help are fundamental safety measures.

World Patient Safety Day reminds us that safe research is not created by one procedure, one profession, or one committee. It comes from well-designed systems, thoughtful clinical judgement, open communication and a culture in which both participants and professionals are empowered to speak up.

For those of us working in pharmaceutical medicine, maintaining that culture should remain central to how we develop medicines and generate evidence for the patients who will ultimately use them.