Clinical trials are meant to produce evidence. Our research shows they're also shaped by everyday acts of care.
By Duncan Reynolds
In this blog, Duncan Reynolds discusses his work on the tension between creating new medical knowledge and providing good care in clinical trials.
Randomised controlled trials (RCTs) are often described as the gold standard of medical research. They test whether new drugs, devices or treatments work by carefully controlling as many variables as possible. Participants are randomly assigned to different groups, strict protocols are followed, and every effort is made to produce reliable evidence that can improve healthcare. This scientific rigour is essential. Without it, we would have far less confidence that new treatments are safe and effective. But there is another side to clinical trials that is often overlooked.
Our research, based on 17 months of ethnographic fieldwork in a UK clinical trials centre, found that trials are not simply technical exercises in data collection. They are also places where staff constantly balance two competing responsibilities: producing good science and caring for the people taking part. We describe this as a tension between a “logic of research” and a “logic of care”.
The logic of research prioritises consistency, standardisation and adherence to protocol. If procedures vary too much between participants, the evidence produced by the trial becomes less reliable. Clinical trials depend on this standardisation. Every participant should, as far as possible, experience the same procedures. If researchers begin making exceptions, the quality of the evidence may suffer. From this perspective, following the protocol is essential.
Yet people are not identical. Participants become anxious, ask questions, struggle with uncomfortable procedures and seek advice about their health. Researchers cannot simply ignore these realities, even if responding to them complicates the neat logic of a trial.
Therefore, we also see a logic of care. This focuses on responding to the needs of individual people as they arise. Rather than treating participants as identical cases, it recognises that each person has unique concerns, preferences and circumstances that sometimes require flexibility.
In practice, these two logics often pull in different directions. For example, we observed participants undergoing procedures they found uncomfortable or even distressing because those procedures were necessary to answer the research question. One participant with a severe fear of needles continued to provide consent for repeated blood tests despite finding the experience extremely difficult. Another participant initially refused to repeat an uncomfortable scan but eventually agreed after the researcher explained why another measurement was needed.
These moments were not simply examples of researchers enforcing rules. Staff spent considerable time explaining procedures, reassuring participants and carefully judging whether continuing remained ethically acceptable. Scientific requirements were being met, but they were negotiated through relationships rather than imposed mechanically.
At other times, care took priority over strict research protocol.
Participants in this research were enrolled in trials focused on high blood pressure. During appointments, staff frequently offered advice about reducing salt intake or making other lifestyle changes that could improve participants’ health. These conversations were personalised and often continued across multiple visits. From a scientific perspective, this creates an interesting dilemma. Lifestyle advice could influence participants’ blood pressure independently of the intervention being tested. In other words, helping participants become healthier might also introduce additional factors that complicate the interpretation of the trial’s results.
Yet staff rarely saw this as a problem. They viewed offering helpful advice as part of their responsibility towards participants. Looking after people mattered, even if it introduced a little more complexity into the research.
This illustrates the main argument that clinical trials are not simply environments where scientific protocols are executed exactly as written. They depend on countless everyday judgements about when flexibility is appropriate and when strict adherence is essential. These judgements are largely invisible in published trial reports. Scientific papers describe protocols, recruitment numbers and statistical analyses. They rarely describe the conversations, compromises and practical decisions that make trials possible in the first place.
Understanding clinical trials in this way gives us a richer picture of how medical evidence is actually produced. It reminds us that high-quality science depends not only on rigorous methods but also on skilled professionals who continually navigate ethical, practical and human challenges. The next time we hear that a treatment has been “proven” in a clinical trial, it is worth remembering that behind every dataset are relationships, conversations and acts of judgement. Medical evidence is not produced by protocols alone. It is also shaped by the everyday work of caring for the people who make research possible.
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