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Insight blog: Posts tagged with clinical trials

Stories about the people, science and research of the Medical Research Council.

Clinical trials: why multi-arms are better than two

25 Jul 2014

A pile of blue and white pillsIn their quest to speed up the discovery of new treatments for patient benefit, MRC researchers at the MRC Clinical Trials Unit propose an efficient solution: the multi-arm clinical trial. But how do these trials work and why should the traditional two-arm clinical trial be the exception and not the rule? We asked Annabelle South, Policy, Communications & Research Impact Coordinator at the MRC Clinical Trials Unit, to explain this change in approach, as published in The Lancet.

Randomised controlled trials are the best way of finding out if new treatments are better than the current standard treatment. But trials take a long time to set up and run, and can be expensive.

Here at the MRC Clinical Trials Unit at UCL we are keen to find faster and more efficient ways of working out which treatments work best, so patients can benefit sooner. That’s why we are urging researchers and drugs companies to move away from the traditional ‘two-arm’ approach to trials, and adopt more innovative, efficient approaches like the multi-arm trial. [...]

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Pete Coffey: Driving stem cells to the clinic

20 Feb 2014

Pete Coffey*

Pete Coffey (Image copyright: UCL)

Professor Pete Coffey, Professor of Cellular Therapies at the Institute of Ophthalmology, University College London, is an MRC-funded researcher who is developing a stem cell therapy for a degenerative eye condition that is the leading cause of blindness in UK adults. He spoke to Katherine Nightingale about the long road to the clinic.

Researchers seldom like to predict how long it might be before their discoveries are tested in patients. “At least five years” is a typical response, but one that should usually be taken with a pinch of salt. Research is complex, there are many obstacles to overcome, and some promising ideas never get anywhere near a clinic.

All the more surprising then that Pete Coffey gave himself and his team five years from 2007 to ready a stem cell therapy for a degenerative eye condition for clinical trials. And perhaps more surprising still — he’s done it.

The condition in question is age-related macular degeneration (AMD). Most people with AMD have the ‘dry’ form, which occurs when a carpet of cells behind the retina start to die. These retinal pigment epithelial (RPE) cells nourish the ‘seeing’ cells of the retina, as well as removing dead cells that would otherwise build up and cause damage. People with AMD gradually lose sight from a part of the retina called the macula, which is responsible for sharpness of vision in the centre of the visual field — the vision needed for reading, driving and recognising faces. There is no treatment for dry AMD. [...]

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The road to randomisation: patulin and the common cold

20 Jan 2014

Women at work in a Royal Ordnance factory in 1943 (Image source: Wikimedia)

Women at work in a Royal Ordnance factory in 1943 (Image source: Wikimedia)

Randomised clinical trials (RCTs) are regarded as a ‘gold standard’ method for assessing the effects of treatments. But how did they come to be accepted? Here Sir Iain Chalmers describes an often overlooked MRC trial of a potential treatment for the common cold, and explains the role it played on the road to randomisation.

When people look back on the history of clinical trials, the MRC trial of streptomycin for pulmonary tuberculosis reported in 1948 tends to receive a lot of attention. But there’s an earlier MRC trial that helped to develop methods to ensure that there is no bias in how patients are allocated to particular treatment groups, to ensure that ‘like is compared with like’. And, unlike the streptomycin trial, this earlier trial used placebos to reduce bias in measuring treatment outcomes.

The trial had been prompted by conflicting reports about possible beneficial effects on the common cold of patulin, a fungal toxin often found in rotting apples. Between 18 January and 11 April 1944, volunteers at three London units of the General Post Office, along with four Royal Ordnance factories, and seven other factories participated in the MRC’s first well-controlled multicentre clinical trial. [...]

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Make all research results public

4 Apr 2013

Iain Chalmers (Copyright: Ian Milne)

Iain Chalmers (Copyright: Ian Milne)

All trials registered, all results reported, a new campaign which the MRC is supporting alongside other research organisations, calls for the results of all clinical trials to be made public. Sir Iain Chalmers, Coordinator of the James Lind Initiative, says that longstanding biased under-reporting of clinical research must stop.

Successful conduct of clinical trials depends on many factors, but these studies are impossible unless patients agree to participate in them. For many patients the principal motivation for participating in clinical trials is the hope that they may receive better care, and perhaps more effective treatment.

All participants in clinical trials, however, believe that their involvement will help to increase knowledge about the effects of treatments. They expect that people with health problems like theirs – and perhaps they themselves – will be able to make better informed treatment decisions in future as a result of their contributions to knowledge.

How come, then, that the research community, including research funders and regulators, have acquiesced for decades in the nonpublication of around 50 per cent of all clinical trials? Can this be characterised as anything other than a gross betrayal of the trust in researchers which motivated volunteers to participate in clinical trials in the first place? How many of them would have agreed to participate if researchers had told them “If the results of this trial don’t serve our academic or commercial interests we won’t make them public”? [...]

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