Abstract
Life might not be fair, but that doesn’t stop us trying to make it fair. Science helps make life fairer by providing evidence on which to base our decisions for better health, a more equal society and a more sustainable planet. But not all science is of itself fair. Indeed, much of published and reported science is flawed, barely believable or outright nonsense. Eighteen months of pandemic policy feuding shows that science doesn’t have all the answers, and that sometimes it can be part of the problem.
The best medical science addresses questions of importance to patients and uses ‘fair’ methods to answer those questions. Fair tests are required to answer research questions about vaccines and treatments. In the frenzy of a health crisis, it is more important than ever to appreciate the effects of bias and the play of chance when evaluating an intervention, to understand the deep history of ‘fair tests’, and to appreciate why absolute truths do not exist in the interpretation of medical science.
Since 2003, the web-based James Lind Library has explained and illustrated the evolution of fair tests of medical treatments. It is now a remarkable collection of wisdom about the greatest global developments in clinical trial design, written by and about the leading thinkers in the clinical sciences. With physical libraries under financial pressures, the James Lind Library shows how libraries can evolve to add value but also to pull us back to coolly consider the hard earned lessons of history and the ‘fair’ principles upon which any new intervention must be evaluated.
JRSM has demonstrated its faith in the important work of the James Lind Library by carrying a contribution each month dating back to 2005, 1 for sound science is the backbone of any ambitious medical journal. Of the two hundred or so JRSM papers that this mutually beneficial collaboration has generated, perhaps this month’s contribution about the RECOVERY trial platform is the most significant?
Amid worries about the reliability of the studies on diagnostic studies, and the concerns about the lack of safety data available from vaccine trials, the RECOVERY and SOLIDARITY trial platforms established to test preventative and therapeutic interventions for COVID-19 have created history before our eyes. SOLIDARITY is a parallel global WHO initiative that shares many of the features of RECOVERY. Glasziou and Tikkinen explain how RECOVERY in particular has built on the trial features long championed by Richard Peto to become a milestone in randomised trial design and execution. 2
RECOVERY has used simple patient entry criteria, a single hard outcome (death) and central randomisation to deliver fast, reliable, ‘fair’ results that have certainly saved lives. The trick wasn’t just simplicity, but also successful democratisation of clinical research, whereby clinicians across the UK supported the clinical trials organised by the RECOVERY team instead of a handful of clinical trial units.
The enterprise was endorsed by the Chief Medical Officers of all four nations. ‘The Nation’s Doctor’ is a role that comes with prestige, respect and invariably controversy. 3 The response to England’s Chief Medical Officer Chris Whitty during the pandemic has exemplified the sharp divide in public opinion about the government’s pandemic performance. To some, he is a hero, a gallant doctor inspiring the next generation; to others, he is an arch villain, a denier of civil liberties. But Whitty will always be able to share in the success and the legacy of RECOVERY, since his leadership of the National Institute for Health Research was key in establishing the network and structure that enabled RECOVERY to be delivered so successfully.
The lessons from RECOVERY are for future pandemics but also for non-pandemic treatment questions. The playbook for funders and trialists is written. But the value isn’t just in the cold detail of a trial protocol or a summary report, it is also in the story of the research and the motivations of the people who created history. That’s why we retell these stories in JRSM, unashamedly standing on the shoulders of the peerless work of the James Lind Library.