Sponsors of clinical trials are required to provide result summaries in a format that is understandable to laypersons, as outlined in the EU Clinical Trials Regulation 536/2014 (Article 37) (EU … Continue Reading Guidance and important steps to consider when writing lay summaries
In 2007, the US Food and Drug Administration (FDA) issued the US FDA Amendments Act (FDAAA), in which it stated that all clinical trials of FDA-regulated products must be … Continue Reading Has the FDA Amendments Act improved clinical trial registration and publication?
In a new paper published in the BMJ, Ben Goldacre and co-workers suggest that pharmaceutical companies have variable policies on the reporting of clinical trials. While some have clear procedures … Continue Reading Audit of pharma policies on the reporting of data from clinical trials
What drives scientists to publish their research? The furtherance of science? The recognition? The advancement of one’s career? At many universities in China, researchers are financially incentivised to publish their … Continue Reading What are the implications of China’s cash-for-publications policy?
The ongoing push towards increased transparency around clinical trials has seen the evolution of regulatory requirements for data reporting and sharing in Europe and the US over the past decade. … Continue Reading The evolution of regulations for improved clinical trial transparency
In recent years, the International Committee of Medical Journal Editors (ICMJE) has been striving to make widespread data sharing the norm. In January 2016, the committee published a proposal to … Continue Reading ICMJE announce new data sharing requirements for publication of clinical trial reports
Many funding organisations now encourage or require researchers to share their datasets in full upon publication, for example by linking to a data repository such as Dryad or Figshare. It … Continue Reading Less than a quarter of top biomedical journals require data sharing
A hot topic in the reporting of clinical research, Medical Publishing Insights and Practices (MPIP) is inviting interested parties to share their perspective and ideas on What Transparency Means to … Continue Reading Join the conversation: what does transparency mean to you?
The pharmaceutical industry has previously been accused of failing to submit all clinical trials data for publication, particularly if the results are unfavourable for the drugs in question. However, a … Continue Reading Does submission or publication bias exist in human drug studies?
In a drive to improve the quality of scientific research, prevent fraudulent reporting, and to reinforce their core belief that openness and transparency are core tenets of scientific research, a … Continue Reading Editor asked to resign from journal after making a stand on data sharing during peer review
Many journals now require authors to make their data freely available after publication. These include the British Medical Journal (BMJ), which first published an editorial encouraging the sharing of data … Continue Reading Data sharing promised but not delivered
The New England Journal of Medicine (NEJM) has sponsored a new initiative to promote the responsible sharing of clinical trial data. The journal is calling for entries in the SPRINT Data … Continue Reading Call for entries: NEJM challenges you to help advance data sharing
“Medicine is a mess”. This is the view of Ben Goldacre, physician and author of Bad Pharma, in a recent article in the Times newspaper. It comes after the publication of … Continue Reading Association between principal investigators’ financial ties to pharma and published trial outcomes
Over two days last month (17-18 January, 2017), around 250 delegates and exhibitors attended the 2017 European meeting of the International Society for Medical Publication Professionals (ISMPP) in London. The … Continue Reading Meeting report: Summary of Day 2 of the 2017 European #ISMPP Meeting
Over two days last week (17-18 January, 2017), around 250 delegates and exhibitors attended the 2017 European meeting of the International Society for Medical Publication Professionals (ISMPP) in London. The … Continue Reading Meeting report: Summary of Day 1 of the 2017 European #ISMPP Meeting
Publishing research with negative or neutral results can be difficult in traditional scientific journals. Similarly, non-typical articles such as those reporting methods may also be overlooked in favour of papers … Continue Reading Innovative publishing platforms encourage sharing of ‘grey literature’