Randomisation in clinical trials

Posted on Jan 7, 2011 by Kelly Gleason in Research

Randomisation is often listed as a barrier to recruitment into randomised clinical trials. It is a difficult concept to explain and most healthcare professionals develop their own personal way of explaining randomisation to their patients.

In 2002, Jenkins et al, carried out research asking doctors, patients and the public, which descriptions, from of a list of eight descriptions of randomisation, they preferred. The outcome was that all groups chose those explanations which were simple, clear and concise, such as ‘once you have agreed to enter the trial, you will be allocated to one of the two treatments with equal chances of each treatment being the one you will receive’.

This research also pointed to explanations that patients found unfavourable, such as ‘their fate resting on a toss of a coin’, or that ‘the treatment decision was made independent of themselves or their doctor’. These explanations did not seem to offer the careful consideration required by a patient when making an important decision about their health.

This research by Jenkins and colleagues in 2002 was helpful in helping us to find the right words and the right tone when explaining randomisation in clinical trials to patients.

A more recent paper by Jenkins et al in 2010, looks at patients’ attitudes towards participation in randomised controlled trials (RCTs). In this study, 55% of participants stated that they would personally be willing to participate in research when their treatment was chosen at random, leaving 45% uneasy about participating in RCTs.

What was interesting, however, was that further along in this paper it states that two thirds of the group of patients that were ‘unsure’ of their willingness to participate in a randomised clinical trial were willing to change their minds if:

the logic of the trial and all the treatments were explained to them
they were made aware that they had the right to withdraw at anytime
they were provided with information about the treatments and possible side effects

These findings emphasize the importance of a full discussion at the time of informed consent, in order to allow those initially ‘closed’ to the idea, the opportunity to reconsider a clinical trial as a treatment option.

For patients, deciding on a treatment plan can be very confusing and grappling with the sheer volume of information being offered can feel overwhelming. Support in decision making can help patients feel more comfortable and confident with their chosen treatment. Research nurses are perfectly placed to offer this support and, arguably, seem to understand the need for such support better than other members of the healthcare team.

A study by Wright et al 2010 highlights the importance of decision support, suggesting that interventions aimed at decision support could positively influence recruitment in to clinical trials. He suggests that ‘total impartiality to the patient’s predicament in an effort to avoid coercion, may not be the most appropriate strategy. Communication approaches that acknowledge, and are empathetic to the difficulties patients’ face when deciding on entry to clinical trials, may be more appropriate.’

This would therefore mean that by supporting patients in deciding on the right treatment, it helps patients have more confidence in their decision and allows them to be more open to the possibility of participating in a clinical trial. I feel it is however important to acknowledge the fine line between coercion, and information and support – always maintaining respect for patients’ vulnerability when receiving a diagnosis and navigating their way through information to find the right treatment, the treatment that fits them and their situation best.

I will mention again, I believe research nurses are perfectly placed to support patients in deciding whether or not to participate in a clinical trial, and that by nature many nurses seem to understand the importance and the power of empathy and support.

Nurses are also good communicators and when familiar with their clinical area, their patients and their studies, they are able to share the necessary information with their patients, give them time to digest this information, process it and communicate their choice for a treatment plan so that they can move forward with confidence and a good understanding of their chosen path.

The three papers mentioned above help us to see that patients need the ‘complete’ information, presented in a simple, clear and concise way – as well as support and guidance to help them choose their treatment with confidence. If this approach also improves trial accrual, then this looks like a win-win situation to me.

Jenkins V, Leach L, Nichills K & Newsham A (2002) ‘Describing randomisation: patients’ and the public’s preference compared with clinicians’ practice’ Br J Cancer 87(7), 854-8.

Jenkins V, Farewell D, Batt L, Maughan T, Branston L, Langridge C, Parlour L, Farewell V & Fallowfield L (2010) ‘The attitudes of 1066 patients with cancer towards participation in randomised clinical trials’ British Journal of Cancer 103(12), p1801-7.

Wright JR, Whelan TJ, Schiff S, Dubois S, Crooks D, Haines PT, DeRosa D, Roberts RS, Gafni A, Pitchard K & Levine MN (2004) ‘Why cancer patients enter randomized clinical trials: exploring the factors that influence their decision’ Journal of Clinical Oncology 22, 4312-18.