On 18 September 2014, following a call for comments from the Health Research Authority (HRA) on their proposals to promote transparency in research, key stakeholders met to discuss feedback on the proposals and what the next steps should be for registering and reporting clinical trials in the UK.
Times are changing for clinical research. The passing of the European Union Clinical Trials Regulation (EU CTR) in April this year will mean changes to how clinical research is approved and conducted. The EU CTR comes into effect in 2016, so it is time to learn from past mistakes and start preparing for a new paradigm.
This is what the HRA has done; it has started the ball rolling for …
Writing in BMC Medicine last week, one of our Medical Editors, Jigisha Patel, made a case for training and specialization in peer review. With kind permission from The BMJ, here we republish a piece by Jane Feinmann which takes a look at the article’s recommendations.
This article first appeared on The BMJ blogs.
Blind faith that the publication of medical research in peer reviewed journals elevates a study to the status of “the evidence,” and therefore “the truth,” may be on the wane among those in the know. But for the public, and a vast number of doctors, this “naïve and misplaced” credulousness persists.
According to Dr Jigisha Patel, medical editor of BioMed Central, this idea must be challenged. Writing in
No one ever said that doing a clinical trial was easy. Indeed it often feels like a Sisyphean task, when faced with obdurate funding committees, or centres that seem unable to recruit a single patient, when just six months previously they were inundated with them. Every piece of research has its pain points; however, sometimes we do have a tendency to over-complicate things.
This was exactly the message of Shaun Treweek’s talk at the 2nd Clinical Trials Methodology Conference in November last year, where he asked if we were making our own lives more difficult than they needed to be. We have a tendency to do trials the way we do because that’s the way we do …
New research published today in Alzheimer’s Research and Therapy has shown that the failure rate for Alzheimer’s Disease drug development is 99.6%. In this guest blog, Dr Simon Ridley, Head of Research at Alzheimer’s Research UK, discusses the challenges we are facing in tackling this devastating condition, and what we can do to address them.
Dementia is the name for a collection of many different conditions, of which Alzheimer’s disease is the most common. Alzheimer’s is characterised by a gradual decline in memory and changes in behaviour and communication. In the later stages, people often forget their friends and family as well as how to walk and feed themselves …
Following the recent revelation that the EMA’s policy on proactive publication of clinical trial data wasn’t quite what had been expected, we look at how this will impact future research and developments in transparency.
Transparency surrounding clinical trials has been one of the hottest topics of recent years. A day doesn’t pass without a study or blog bringing it to our attention, and for good reason; without access to all clinical trial data it is impossible to make informed clinical decisions, which puts people at risk.
Over the last few years, initiatives and pledges to increase transparency have come from all directions, from regulators to pharmaceutical companies, and from publishers to researchers. We have the AllTrials initiative, the passing of …
A few weeks ago I played the part of an expert witness in the Medical Journalist Association’s mock trial, Trials on Trial. The charge was: “Is the current system of publishing clinical trials fit for purpose?” The jury’s verdict was a resounding ‘no’. You can read more about the event in Jane Feinmann’s write up on the BMJ Group Blogs.
As an expert witness on a panel tasked with giving evidence on different elements of publishing clinical trials, I was asked “how does open peer review work and does it address all the flaws of the current system of publishing clinical trials?”.
I gave my evidence on why I believe that open peer review is the …
With the advent of the AllTrials initiative, the EU Clinical Trials Regulation and the recent Tamiflu debacle, randomized controlled trials (RCTs) have received a lot of attention over the last 12 months. Despite all this recent furore surrounding the reporting of RCTs, there are those of us who have been banging this drum for a while.
These are nothing new, and it was in 1994 that a group of determined researchers, collaborating with medical journal editors, published SORT, which was to become the first Consolidated Standards of Reporting Trials (CONSORT) statement in 1996. Twenty years later, the CONSORT Group held its most recent meeting in the Château d’Ermenonville, Paris, which I was delighted to have …
‘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 …
Been too busy to follow all our blogs over the last month? Never fear! We’ve done the hard work for you and pulled together some of the highlights from across our blogs network in April.
Are journals ready to abolish peer review?
At the beginning of the month, one of BioMed Central’s Biology Editors, Maria Kowalczuk, took part in a debate at City University ‘Is peer review broken?’. In this blog, Anna Perman and Tim Sands write that the debate concluded it’s ‘chipped, not broken’.
But that was just the start of a busy month for Maria, as she went on to write about in ‘Are journals ready to abolish peer review?‘. And it wasn’t just Maria getting involved: our Editors …
Thursday 10 April saw the publication of the Cochrane systematic review on oseltamivir and zanamivir, or Tamiflu (Roche) and Relenza (GlaxoSmithKline) to give them their better-known trade names. In short, the review found that Tamiflu doesn’t work quite as well as we thought; a finding that is the culmination of a four-and-a-half year battle for access to the raw data from the clinical trials.
The authors – Jefferson, Heneghan and colleagues – uncovered what they characterized as ‘multisystem failure’, with poorly-defined endpoints and confusion as to the authorship and contribution of the clinical trials. They also found that all studies were conducted against placebo, rather than against current best practice. Overall, the reviewers felt that the published studies were …