It’s important that the European Medicines Agency hears from lots of different voices in support of their good proposals on sharing clinical trial data. So please send them something, even something short. Below is the summary of our response. Please feel free to borrow from this for your response. Remember that the deadline for responses is […]
Should we banish the term ‘negative trials’?
24th September 2013
Sir Iain Chalmers of The James Lind Alliance writes:
I wrote about this in 1985 and I think it is still relevant. Too often people refer to trials as either ‘negative’ or ‘positive’ based on whether or not statistically significant differences between treatments have been found. This dichotomisation […]
European consumer org to support EMA in court cases
20th September 2013
The European consumer organisation BEUC, which represents 41 consumer groups across the EU, has been given permission to support the European Medicines Agency (EMA) in the court cases the agency is currently fighting. The EMA was sued in February 2013 by pharmaceutical companies AbbVie and […]
Organisations to explore role of professional bodies in clinical trial transparency
19th September 2013
Two UK based professional bodies are going to explore what the role of professional organizations can support their members in adhering to standards for clinical trial transparency. The British Pharmacological Society (BPS) and the Royal Pharmaceutical Society (RPS) are both signatories to the […]
The UK’s House of Commons Science and Technology Select Committee has published its report on Clinical Trials today. The Committee described the current lack of transparency of many clinical trials as “unacceptable”, adding that it has not been impressed with Government efforts to tackle the problem to date. The report supports the AllTrials campaign’s calls […]
BPS and ASPET announce support for publication of negative findings from clinical trials
13th September 2013
The British Pharmacological Society (BPS) and the American Society for Pharmacology and Experimental Therapeutics (ASPET) have announced their support for the publication of negative findings from early clinical trials. Their jointly published journal, Pharmacology Research & Perspectives, is at the same […]
The Health Research Authority (HRA) is implementing its plan to ensure UK clinical trials are registered in a publicly accessible database. From 30th September registration of the trial within 6 weeks of the first patient being recruited will be a condition of a favourable ethical opinion.
Failure to comply with this requirement will be a breach […]
The European Medicines Agency wants to hear opinions on its proposed policy on sharing and publishing information from clinical trials. The Agency has committed to proactively publish information from clinical trials submitted in support of a marketing authorisation application, once the decision-making process has ended, and sets out a model for sharing commercially confidential information and […]
BMJ study finds many smaller medical journals do not require clinical trial registration
11th September 2013
Only 28% of medical journals require clinical trials to be registered before they publish a report, a paper in the BMJ has found. Elizabeth Wager and Peter Williams looked at a random selection of 200 medical journals and asked journal editors […]
Pharmaceutical company representative argues that information on adverse effects of drugs should be kept confidential.
On the one hand, some companies such as GSK and Roche are putting a lot of work into making a change to culture and practice that would see transparency become the global norm in drug trials. On the other hand, there are other companies suing the European Medicines Agency to prevent release of clinical trial […]