Feeding back the results of clinical trials to participants has long been seen as good ethical research practice, and new guidance from the Health Research Authority, the national regulatory body for research in England, makes it clear that feedback is part of researchers’ commitment to participants. But what are the consequences of sharing results with participants? Our new study investigated how participants reacted to negative trial findings, and found that the impact of sharing results is far from straightforward.
We interviewed 38 women who had taken part in a clinical trial in pregnancy and a subsequent long-term follow-up of their children. The trial tested two antibiotics that were believed to be helpful for treating pre-term labour or pre-term broken waters. The trial (1,2) and follow-up research (3,4) – led by Dr Sara Kenyon and colleagues – unexpectedly found that the children born to women who had had one or both antibiotics were at increased risk of health problems.
The trial findings were very important, and helped to change standards of care for pregnant women and their babies. The findings were also unwelcome, since everyone involved had hoped to find evidence of benefit of the antibiotics – or at least no harm. Despite this, around three-quarters of the women we interviewed remained comfortable with their choice to take part in the trial. Many acknowledged that research involves uncertainty, and that the negative outcomes of the trial had to be balanced against the importance of knowledge gained about safe care for women and their babies. Receiving the results allowed them to feel they had contributed to the ‘common good’, and thus to retain a sense that participating had been a positive experience. This participant expressed a common sentiment:
Just the thought that something that you’ve done might help somebody in your position in the future’s a really good feeling.
But the impact of getting these results was more negative for around a quarter of the women in our study, who reported feelings of guilt, regret, and anger about the negative outcomes. Although the trial had been conducted according to best ethical practice, with careful attention paid to informed consent, some women were shocked at the outcome and felt let down by the doctors, midwives, and researchers involved. Some felt that it should have been possible for regulatory systems to anticipate and prevent any risk of harm. Getting the results led to the profound experience of a breach of trust for this small group women. One woman said:
[I am] shocked that they could give a drug like that and not fully know what the reaction would be to the unborn baby.
The nature of randomised control trials makes some sort of distress at the results very likely. By their very definition trials compare whether a given treatment is beneficial for patients compared with controls, and there is always uncertainty about what the outcomes will be. When findings show no benefit from new treatments, or evidence of side-effects or harm associated with trial participation, some patients will feel upset or disadvantaged. Even following consent protocols and ethical guidelines to the letter may not be enough to prevent this; indeed it is probably an inevitable outcome that has had too little attention so far.
Our study raises important challenges. How can researchers uphold commitments to feedback research findings, while avoiding the risks of patient distress and of potential damage to trust in medical research?
Better public understanding of clinical trials would clearly help. If patients fully understand the uncertainties inherent in clinical trials then they are less likely to be shocked or disturbed by negative trial findings. Good resources are out there – the NHS choices website includes fair and clear information about the implications of taking part in clinical trials, including a helpful video by Ben Goldacre, and a page on joining a clinical trial, which clearly states that new treatments ‘may turn out to be no better, or to be worse, than the standard treatment’. But not all potential trial participants will seek out these resources, and the fact remains that patients often enter trials in the hope of a positive outcome.
For researchers, it will remain important to recognise the potential for the feedback of results to cause distress or other negative emotions. This underlines the importance of finding ways to support participants when trial results are shared with them.
Dr Kenyon said ‘In sending the findings to participants we went to great efforts to think about how this should be done and to put support in place for those who might need it. We consulted trial participants on the content and layout of the results leaflet, alerted all GPs in England as to what the results were, and set up a helpline that women could call if they needed support after receiving the results. My advice would be that in the future researchers should ensure they have adequate resource and time to enable consideration of the possible impact on participants and careful preparation of the feedback process.’
Sharing of research results appears on the face of it to be an ethical obligation, but we need a more nuanced understanding of what constitutes ethical practice in feeding back trial findings to participants, and a recognition that the right approach may vary depending on the nature of the trial and of the findings themselves.