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 …
“Truth never damages a cause that is just” – Mahatma Gandhi
Today, European Parliament will vote on the EU Clinical Trials Regulation, including changes to legislation regarding transparency in Europe.
Over the last 30 years, the battle for increased access to clinical trial data has grown in strength. Without publically-available clinical trial results and methods, it is impossible to make informed clinical decisions. The huge, collaborative support seen for the AllTrials initiative is a clear sign that campaigns for greater transparency are gaining momentum.
The estimated percentage of unpublished clinical trials is hotly debated, and lies somewhere between 10% and 50%, depending on what methodologies were used or what article you read. Furthermore, positive results are more likely to be published than …
Posted on behalf of Lisa Hussey, Associate Publisher, BioMed Central
Food allergies affect up to 8% of children in the US, and 30% of those affected have more than one allergy. It has been estimated that food allergies cost US$25 billion each year, with approximately US$20 million borne by families of people with food allergies.
Oral immunotherapy (OIT) is an effective treatment for food allergies, which works by desensitizing patients to the allergen by slowly increasing the doses of modified allergen that they can tolerate. The initial and maintenance regimen for OIT is usually spread over 3-5 years and has been shown to remain effective for several years after cessation of treatment.
One of the …