From guinea pigs to partners: a changing relationship with research participants
People enrolled in clinical trials are often active partners in research, but this wasn’t always the case. Here Dr Jane Cope, former Director of the National Cancer Research Institute and an MRC staff member for more than 30 years, looks back on how patients have changed from passive subjects to active partners in clinical trials.
In the early 2000s, when working at the MRC Clinical Trials Unit, I took a call from a man who rather gruffly enquired about our guinea pig research. Animal activists had been in the news, so I told him rather curtly that we weren’t involved in anything like that. Only after I put the phone down did I realise he was probably asking about clinical trials. I should have advised him to talk to his doctor.
This example serves to show how even a decade ago, as a non-clinician involved in research, I was not in touch with how patients talk about trials ― it hadn’t occurred to me at first that ‘guinea pigs’ might mean people. Fifty years ago, in 1964, the MRC published guidelines on ‘Responsibility in Investigations on Human Subjects’. The MRC was a pioneer of clinical trials, but the term ‘human subjects’ now seems dated, if not as offensive as ‘guinea pigs’. Today we talk about ‘involving patients’ and ‘participants’ in trials. And it is not just the language that has changed.
Take the issue of consent in clinical trials. In 1964, the MRC said that if the doctor had ‘reasonable grounds’ for believing that a new procedure would benefit a patient, it was OK to simply assume the patient’s consent. They suggested it would be considerate to get the patient’s agreement but this is a long way from the fully informed consent required today.
With some kinds of research, doctors know that participants are unlikely to benefit directly ― the purpose is to learn how to better treat patients in the future. In 1964, the MRC thought that, in general, researchers should gain consent for these trials. But for patients with a possibly fatal illness, they said it may not always have been in patients’ best interests for researchers to indicate that they didn’t know which was the best treatment.
This was still the advice when I joined the MRC as a research manager in 1983. I was told that in cancer research, patients were not always asked for consent because they weren’t even being told they had cancer. That shocked me. But we were coming to the end of the paternalistic era of ‘doctor knows best’.
The AIDS epidemic, which started in the 1980s, affected, among others, a young and politically vocal group of patients – gay men. As portrayed in the film Dallas Buyers Club, they wanted new treatments now even if they were unproven. In the US some patients sabotaged double-blind trials by pooling their tablets and sharing out the mixture. That way all patients were likely to get some active treatment as well as some dummy pills. Doctors started to realise they would need a collaborative relationship with patients if trials were going to work.
In the 1990s in this country, The Health of the Nation, the government white paper of 1992, brought in targets relating to health improvements rather than processes like reducing waiting lists. The term ‘evidence-based medicine’ came into use, and in 1993 the Department of Health set up their Health Technology Assessment (HTA) programme, which complements the MRC’s fundamental research. The National Institute for Clinical Excellence (NICE) was started in 1999 to assess evidence and decide which new treatments should be introduced into the NHS. It was no longer OK for doctors to experiment on the basis of a hunch.
When I joined the National Cancer Research Institute (NCRI) in 2004, I was delighted to find an active Consumer Liaison Group, whose members were working with study groups, planning trials across many tumour types. Patients (or service users as some like to be known) and carers now influence study design and sometimes make the difference between success and failure.
For example, researchers running a trial in prostate cancer, known as ProtecT, consulted groups of patients about how they would prefer to be approached about participating, and how the trial was described to them. When the results were implemented, the acceptance rate for the study rose from 40 per cent to 70 per cent of those asked. Coming from behind in the 1980s, cancer research is now leading on patient involvement: at NCRI I was in touch with patients and carers on a weekly basis.
Now patient choice is a mantra, which is good for many of us. As a patient, I want to analyse the pros and cons of all treatment options open to me, and research possibilities too. But not everyone is like me and some patients do still want a doctor to take responsibility for the decision. And there is no single answer to the right language for professionals to use either: participants? consumers? service-users? Take your pick, so long as it’s not ‘guinea pigs’.
Jane will be reflecting on her 30 years of working for the MRC and NCRI in the next issue of Network magazine.
Find out more about the MRC and clinical trials governance.