A brave new world – ‘research with’ not ‘research on’ patients

James Lind
James Lind (1716–1794)

‘On the 20th of May 1747, I took twelve patients in the scurvy, on board the Salisbury at sea. Their cases were as similar as I could have them.’ James Lind

This is a description of one of the first ever clinical trials, investigating the impact of citrus fruit on scurvy. According to Lind, scurvy caused more deaths in the British fleets than French and Spanish arms combined, and it was this that prompted him to pioneer one of the first clinical trials in the history of medicine.

It is now 267 years to the day since James Lind’s seminal work, and the way in which clinical trials are conducted has changed dramatically. Medical research has seen huge advancements, including novel study designs, better methods of blinding and randomization, more sophisticated statistical methods and better definition of outcomes.

However, while the intent behind clinical trials was, and remains, to help inform the treatment of patients, for many years their role was viewed solely as a passive one – a data point. ‘Their cases were as similar as I could have them’ Lind said.

It is difficult to pinpoint any one time to mark the change in attitudes towards patient and public involvement in research. There are some examples from as early as the 1970s, such as Rose Kushner’s thorough review of evidence of the effects of radical mastectomy, as well as more recent examples, like that provided by well-organised groups of people with AIDS in the 1980s, as evoked by the recent blockbuster Dallas Buyers Club.

Since the recognition and acceptance of patient and public involvement, there has been a rapid accumulation of evidence regarding its worth and it has been implemented in many health-care systems across the globe. Here in the UK, the National Institute for Health Research (NIHR) is now established as part of the government strategy ‘Best research for best health’, and is thinking differently about patient and public involvement in research with the ‘Breaking Boundaries’ review. We caught up with Simon Denegri, NIHR National Director for Public Participation and Engagement in Research and Chair of INVOLVE, to ask him his views on the role of patient and public involvement in research – past, present and future.

While there has been huge progress in involving patients and carers in research, there are still many barriers, not least the rather idiosyncratic language often used in research articles. In 2011, the Association of Medical Research Charities examined how patients and the general public could be given the right tools to make sense of the increasing amount of research reported in the media. One of the key findings was that all published scientific papers would benefit from having a summary section in plain English. While this is far from the case today, efforts are being made to ensure that trial information is more accessible and understandable to the general public.

Besides the overarching ethical mandate for patient involvement, as captured by the ethicist Raanon Gillon in 1994, active participation of patients in research can potentially improve the credibility of the results, due to higher rates of enrolment and retention, as well as increase their direct applicability to patients, by leading the researchers to ask pertinent questions about outcomes that the patients themselves consider important. However, these are all ways in which patient participation can help the researcher, neglecting the many ways that it can be beneficial for the patient themselves.

We spoke with Karl Stengal from Denver, Colorado, who has been a participant of three separate clinical trials for the treatment of his Parkinson’s disease, about his views on patient participation:

Patient involvement in research is founded on the belief that a collaborative approach to research is necessary if the uncertainties that matter most to patients are to be reduced. While clinical trials have come a long way from Lind handing out oranges and cider on the deck of the Salisbury, encouragement is still needed to promote true collaboration and partnership between clinical trialists and patients.

To celebrate International Clinical Trials Day 2014, BioMed Central’s Medical Evidence portfolio is offering a 25% discount for all articles submitted during the week from 19 May to 27 May.  Full details are here.

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