Pharmaceutical companies are showing a ‘significant trend’ towards increased clinical trial transparency according to a new ABPI study published in the peer-review journal Current Medical Research and Opinion (CMRO).
24 Nov 2016 Posted in News Release By Press Office
The study – Clinical trial transparency of recently approved medicines – is the latest in a series spanning a five-year period, and shows results of 90% of clinical trials on all 34 new medicines approved by the European Medicines Agency (EMA) in 2013 were disclosed within a 12-month timeframe.
Together with results from two earlier studies, this research, conducted by Livewire Editorial Communications on behalf of the ABPI, indicate that the disclosure rate of industry-sponsored clinical trials at 12 months has steadily improved year on year from 71% in 2009 to 90% in 2013.
"These latest findings highlight the trend towards increasing rates of disclosure for pharmaceutical industry-sponsored clinical trials, reaffirming the industry's commitment to greater transparency across all of its relationships and activities," said Dr Jacintha Sivarajah, Head of Medical Affairs at the ABPI.
"Whilst we are delighted to see such positive progress, we acknowledge that there is more work for the industry to do globally on increasing openness around clinical trials and we will continue to work with our European and international counterparts to achieve this."
This study assessed all completed company-sponsored trials related to new medicines approved by the EMA in 2013 and shows that of the 539 evaluable company-sponsored clinical trials related to 34 new medicines licenced to 24 different companies:
Dr Bryan Deane, co-author of the report, said: "The pharmaceutical industry continues to improve on its commitment to greater transparency in clinical trials. Analysis suggests a significant trend towards increasing rates of clinical trial results disclosure at 12 months over the continuous five-year period of EMA approvals assessed in this ongoing study."
Seventy two percent (28/39) of the undisclosed trials were early phase I or II trials. Many of these were initiated more than ten years ago, prior to the publication of industry commitments, implementation of regulatory requirements and the availability of clinical trial registries, and at a time when they would not have been expected to be published as individual studies.
"As long as medicines that began development before 2005 are still reaching approval the disclosure rate is unlikely to reach 100%. These early stage trials pre-date industry's commitment to greater transparency," added Dr Deane.
"However, now that registration and reporting of clinical trials has become routine and industry, particularly large multinational companies, is increasingly focussing on ensuring its transparency requirements are fulfilled, it is reasonable to expect that the trend for increased disclosure rates will continue."
The study highlights two ways in which disclosure rates could be improved or more easily tracked in future years in areas where the report authors and others studying disclosure rates have found difficulty in tracking information:
"The medicine development process is a global and complex process and, although the industry is making great strides in its commitment to greater transparency, we recognise the implementation of globally effective systematic processes to achieve this will take time," added Dr Sivarajah.
* International Committee of Medical Journal Editors. Recommendations for the Conduct, Reporting, Editing, and Publication of Scholarly Work in Medical Journals—updated December 2015. Available at: http://www.icmje.org/recommendations/ (Last accessed 24 May 2016)
** World Health Organization. WHO Statement on Public Disclosure of Clinical Trial Results. April 2015. Available at: http://www.who.int/ictrp/results/reporting (Last accessed 24 May 2016)
All ABPI reports on clinical trial transparency are available for download:
Clinical trial transparency of recently approved medicines (2016) can be downloaded here.
Clinical trial transparency update (2015) can be downloaded here.
Clinical trial transparency (2014) can be downloaded here.
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The ABPI represents innovative research-based biopharmaceutical companies, large, medium and small, leading an exciting new era of biosciences in the UK.
Our industry, a major contributor to the economy of the UK, brings life-saving and life-enhancing medicines to patients. We represent companies who supply more than 80 per cent of all branded medicines used by the NHS and who are researching and developing the majority of the current medicines pipeline, ensuring that the UK remains at the forefront of helping patients prevent and overcome disease.
Globally our industry is researching and developing more than 7,000 new medicines.
The ABPI is recognised by government as the industry body negotiating on behalf of the branded pharmaceutical industry for statutory consultation requirements including the pricing scheme for medicines in the UK.