Personal experiences of taking part in clinical trials – A qualitative study

Abstract

Objective

To investigate people's experiences of and attitudes to participation in clinical trials.

Methods

42 in-depth qualitative interviews, covering different types of trial and intervention, analysed thematically using a modified grounded theory approach.

Results

Many participants argued for a right to participate in research. This may be partly because personal benefit was a common primary motivation for taking part – but the benefits cited were not only personal health outcomes. Whilst most were satisfied with information received, some felt it was too complex. Gaps in understanding were evident, especially around randomisation, but trust in trial staff was high. Desire for feedback of trial results was common.

Conclusion

Unintended consequences may arise from efforts to give full information and challenge therapeutic misconceptions. People wanted ‘enough’ information to help them decide, but their definition of ‘enough’, and the relative importance of written information versus discussion/advice from trusted professionals, varied by individual. In seeking to minimise misunderstanding we stress uncertainty and risk but have perhaps lost sight of the value people derive from trial participation.

Practice Implications

Better information on trial availability, shorter trial leaflets and greater emphasis on face-to-face discussion are suggested. Recruitment literature could appeal to a wider range of benefits.

Introduction

Clinical trials are necessary for the advancement of medical science and the improvement of healthcare. Trialists rely on the public's willingness to volunteer, and reaching recruitment targets can be a challenge. Members of the public who volunteer do not always have a clear understanding of trial process or design, despite the best efforts of ethics committees and researchers. There is an extensive literature on problems in understanding trials and ways to improve information-giving [1], [2], [3], [4], [5], [6], [7], [8], [9], [10], [11], [12], [13]. Ethics committees are rightly concerned that people should not feel coerced into taking part, and that they should understand the uncertainty and potential risks involved in testing new interventions. There is particular anxiety about ‘therapeutic misconception’ [14], whereby patients misunderstand the purpose of a clinical trial to be therapeutic. As a result, efforts are made to avoid misleading mention of personal benefit. UK National Research Ethics Service guidance notes: ‘It is important not to exaggerate the possible benefits’ and suggests as a model formula ‘We cannot promise the study will help you but the information we get from this study will help improve the treatment of people with [name of condition]’ [15].

However, what is meant by ‘personal benefit’ is often narrowly focused on direct health outcomes. We have argued elsewhere [16] that people's reasons for taking part are multi-faceted and many people cite benefits which have little to do with direct clinical improvement, including more relaxed and more frequent appointments or access to an expert team. Other studies have also found that people are motivated by considerations of personal benefit as well as more moral or altruistic concerns [17], [18], [19], [20]. Using an extended form of the Health Belief Model, Verheggen et al. suggest people considering trial participation make a ‘personal balance account’ in which they weigh up the physical and emotional benefits they expect from a trial against the risks and time commitment involved [21]. Yet such benefits are rarely addressed in information given to patients.

A further consequence of efforts to ensure informed consent is that participants are expected to read large amounts of often complex information. Even with lay involvement to help simplify language, information sheets may be long and detailed. Manson and O’Neill [22] argue that ‘widely accepted informed consent requirements…typically propose exaggerated and impractical standards’ (p. 183). As Fortun and colleagues demonstrate [23], comprehensive trial information sheets can result in poor understanding and low recall of risks. They suggest in their study it was ‘not so much the content but the sheer length that may have discouraged subjects from reading the sheet correctly’, and propose that shorter leaflets might actually produce more informed consent, especially if combined with increased interaction between participant and researcher. This is supported by a systematic review of interventions to improve research participants’ understanding [8], which found that extended discussion between study staff and research participants resulted in statistically significant increases in understanding in three of five trials, and trends towards improved understanding in the other two. The review found little impact from various strategies to improve leaflet readability, apart from one study where halving the length of the form produced significant improvements in understanding [24].

In this paper we report findings from a recent qualitative interview study, which aimed to investigate experiences of and attitudes to clinical trials, and in particular opinions about the need for conducting clinical trials research, motivations for taking part, understandings of trial process and design, and receiving feedback about trial results.