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The estimated percentage of unpublished clinical trials is hotly debated, and lies somewhere between 10% and 50%, depending on what methodologies were used or what article you read.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 …
Late last year, ministers, researchers, pharmaceutical companies and charities from around the world gathered together at the G8 dementia summit to make a declaration and commitment for global action against dementia. This led to a significant increase in the budget to spend on research into the prevalence, diagnosis, clinical care, and policy issues in dementia, and the latest advances in these topics were highlighted last week at the 16th national conference on dementias in London. Some of the main discussions from the meeting have been highlighted below.
Prevalence and improving quality of life
Martin Prince gave an excellent overview of groundbreaking global epidemiological studies including some from the 10/66 Dementia Research Group. One of …
“It is difficult to make informed decisions if publication bias and selective reporting are present”
World Health Organization
For years, researchers have drawn attention to this, highlighting discrepancies between protocols submitted to research ethics committees and those reported in the results papers, issues concerning statistical power, and the difficulty in identifying unpublished studies. Indeed, it was concerns like these that lead to most major medical journals making registration of clinical trials a prerequisite for publication.
However, even for those clinical trials that have been registered, it can be difficult to track down related content. Not all journals publish the trial ID in the body of the article; therefore, although a results article may cite …
Published on behalf of Robin Packer
Over the last year, there has been a growing demand for increased transparency in clinical trials. The increasing momentum is demonstrated by the launch of the AllTrials initiative in January 2013, calling for all clinical trials – past and present – to be registered and their results reported, and further by the recent report by the UK Parliament Science and Technology Committee, which calls for the UK to stand up and show the world how greater transparency might one day be applied at a global level.
BioMed Central continues to support efforts to increase transparency through our policy to require registration of all clinical trials, the publication of
The AllTrials campaign (explained in a recent interview in our online magazine Biome) and books such as Ben Goldacre’s Bad Pharma have brought the issue of registration and reporting of clinical trials into the spotlight. The push for greater transparency continues to gain momentum. Recent discussions around the European Medicines Agency’s (EMA) proposal to proactively publish the information submitted to them as part of the standard marketing-authorisation application process has further brought the issue to the forefront. This data submitted to the EMA would be made available for independent reanalysis, after the EMA have completed their decision making process on the application.
Recently, BioMed Central attended a panel discussion organised by Oxbridge Biotech Roundtable (OBR) in which panellists, …
Clinical trials in Alzheimer’s disease (AD) are under enormous pressure to produce results, as there have been no new successful AD drugs in recent years. A large multi-centre study published in Alzheimer’s Research & Therapy identifies an important issue in AD clinical trials; that participants that have been on acetylcholinesterase inhibitor (ChEI) treatment for mild AD may skew results when included in a study for a new drug.
Currently, the main treatment for mild-to-moderate AD is ChEIs, which include donepezil, rivastigmine and galantamine. These have been shown to have positive symptomatic effects on cognition and function and act by improving neuronal communication by preventing acetylcholine (ACh) degradation. Levels of ACh in the synaptic cleft of …
“Industry and academics must share all trial results: without this information, doctors are misled, and patients are harmed.” That’s Ben Goldacre summing up the motivation behind the campaign AllTrials, and yes, it’s just that simple.
Launched in January 2013, AllTrials is an initiative on behalf of Sense about Science, Bad Science, the BMJ, and others calling for practical steps from regulators, industry, funders, and publishers and learned societies in order to ensure all trials are registered and reported. By highlighting the value of negative results, the AllTrials initiative is part of a growing effort to eliminate publication bias toward positive results and complete the scientific record. AllTrials is not concerned with patient data, regulation of …
Posted on behalf of Helene Faure
Clinical trials have been in the spotlight for a number of months in the UK, from the publications of Dr Ben Goldacre to the launch of the AllTrials campaign to demand public listings of all clinical trials (read an interview in the BioMed Central magazine Biome), from a major Parliament Enquiry to the Health Research Authority – which looks after the interest of trial participants – insisting on timely reporting of trials.
Plainly and simply, there is a general consensus that scientific information and results around clinical trials should be made more accessible and understandable to the general public. Not only research funders and policy makers but publishers have a role to play …
On May 20, 1747, James Lind pioneered a scurvy trial on board the HMS Salisbury. Providing some crew members with two oranges and one lemon per day, while others were given cider, vinegar, sulphuric acid or seawater, along with their normal rations, Lind’s experiment is ranked as one of the first clinical trials in the history of medicine. More than 250 years later, the anniversary of his groundbreaking work is celebrated as International Clinical Trials Day. Held annually by the National Institute of Health Research, the principles of Lind’s work still form the basis of modern clinical trials.
In a commentary for Trials, Dr David Sackett offers his perspective on more recent developments in clinical …