Clinical Trials

Being asked about taking part in a trial

How people are asked to take part will depend on the type of trial. At one end of the spectrum, people may themselves actively look for trials to join, or answer adverts in newspapers, newsletters or notice boards. Often people will be contacted through their GP. The GP may speak to patients personally or send a letter on behalf of the trial, or the trial may get the GP’s permission to contact suitable patients directly. In some cases, trials are based in GP surgeries.

Several other people we talked to had been approached in hospital, perhaps at a time when they were feeling vulnerable and worried, for example after a serious diagnosis or an urgent admission. The approach might come from their consultants, or from other staff involved in their care such as midwives or nurses, or from research doctors or research nurses.

As in Sue’s case, people will normally be given a few days or even weeks to go away and think about it, and most felt this was a good approach. A few people did not want the thinking time they were offered. Rose said immediately she would take part in a trial but the doctor “seemed to get most perturbed by this” and insisted she take the leaflet home and read it. Others commented that having too long to wait and think could make people feel anxious, especially if they were keen to get treatment started. In some cases it may not be possible to have much time to think, especially if a decision about treatment is needed very quickly.

As in Merilyn’s case, the importance of having a good rapport with staff was a common issue, whether or not people had to make up their mind quickly. Often people said they wanted to trust someone to advise them. On the other hand, Rose said it would be a bad thing if people said yes just because they got on well with staff. There is considerable debate about how much information is ‘enough information’ to be sure consent can be properly informed. (See also ‘Information and questions’).

There should never be any pressure on anyone to join a trial, however little time is available. Virtually everyone recalled being told it was their decision, and remembered staff making every effort to explain but not to influence them. Just occasionally people sensed that health professionals were really hoping they would say yes, even if they did not say so out loud. In one case, Elizabeth felt under a bit of pressure from the consultant when he came to see her after her operation. She said, “I felt that was the main thing behind the consultation, really, getting me on that trial.”

Approaching patients raises practical and ethical difficulties for staff.

Many people remembered staff being very careful to say that the trial might not bring them any personal advantage, while others, particularly in drug trials, felt they were being offered the possibility of extra benefit. Wendy, for example, said the professor told her she was an “ideal candidate” and “led me to believe it was a really successful drug, and that’s why they were trialling it with other people.” Staff who are very committed to a particular trial may try to ‘sell’ it to patients in subtle ways and they may be unaware that they are doing so.

Of course trials are done because there is a possibility that a new treatment will be better than the standard or control treatment, and it may have already been shown to work for other conditions or groups of patients. However, trials are just as likely to find that new treatments are no better, or indeed worse. Patients who desperately want to get better may interpret doctors’ words in a way doctors do not mean, or “read between the lines”, as Wendy said. (See ‘Feelings about being allocated (randomised) to a treatment group’). This underlines the importance of staff being very careful about what they say and how. Patients may feel that there are benefits from participating, such as extra monitoring and appointments, or a feeling of helping others, but they need to make these judgements based on unbiased information about the trial. (See also ‘Reasons for taking part – personal benefit’ and ‘Reasons for taking part – helping medical science and other people’).

Patients are often unfamiliar with hospitals and research, and some felt staff did not do enough to explain who they were and what organisation they worked for. There is a website called Research People (see Resources), where you can see people involved in research teams talking about their different roles. One day Danny noticed a staff badge saying ‘Research scientist’. She said, “No-one told me that I would actually be being handled by research scientists. Now, I don’t know if that’s someone with a biology ‘O’level or whatever, or they’re doctors. I don’t know. I haven’t got a clue.” Marie was also not sure who she was talking to about the trial. (See also ‘Funding and publishing trials’).

Gill thought it was important for researchers setting up trials to think ahead about how people would be asked to take part and talk to staff who would be approaching patients on their behalf. Otherwise they might not be aware of important practical problems.

If staff are not consulted or properly involved, they may not explain things properly, or may put people off. A participant in another Healthtalk study of antenatal screening was told by her midwife there was a local trial of screening in pregnancy for sickle cell anaemia. She recalled the midwife encouraging her to say no.

“I just felt so overwhelmed with tests that when she asked about it I just thought, “I can't do this.” And then she was behind the blinded envelopes, she had these two envelopes and she was just holding them up saying ‘Say no, say no.’ And I was going to say no anyway, but I said no, and she said, ‘Oh that's good, it's so much paperwork’.”

(See also ‘Information and questions’, ‘Difficulties finding a trial to join’, ‘Public awareness and involvement’ and ‘Messages for health professionals’).

Last reviewed July 2015.

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