The study, published in the peer-review journal Current Medical Research and Opinion (CMRO), highlights a positive trend of increasing levels of disclosure for industry-sponsored clinical trials, but shows that more remains to be done. The Association of the British Pharmaceutical Industry (ABPI) is calling for this research to be a catalyst for further change, leading to greater transparency across the pharmaceutical industry.
The study, which was commissioned by the ABPI, surveyed various publicly available information sources to identify all industry-sponsored trials recorded on a clinical trial registry and/or included in an European Public Assessment Report (EPAR) relating to all new medicines approved by the European Medicines Agency (EMA) over a recent three-year period (2009-2011 inclusive). In this period, there were 997 evaluable trials in patients posted across all registries and databases, relating to 53 new medicines1. From this information, an assessment was undertaken on the disclosure of results of clinical trials which were conducted in patients and sponsored by pharmaceutical companies for new medicines recently approved in Europe.
The key findings show that:
• Over three quarters (76%) of all industry-sponsored clinical trials for new medicines recently approved by the European Medicines Agency (EMA) had some results disclosed within a year of completion or of regulatory approval.
• Rates of disclosure have continued to rise and almost nine in ten (89%) of these trials had disclosed results by 31 January 2013.
This is thought to be the first study to assess the proportion of industry-sponsored clinical trials for which at least some results were publicly disclosed by searching a range of clinical trial registries and databases, and/or by publication in the scientific literature, without regard to prevailing reporting requirements.
Commenting on the report, ABPI Chief Executive Stephen Whitehead said:
“The ABPI is a strong advocate for transparency in clinical trial data, so it is encouraging to see a distinct upward trend towards even greater disclosure of results in industry-sponsored trials. However, more can be done to achieve even greater transparency. There are no quick fixes to this global issue, but this research provides an important baseline that identifies where there is still work to be done. As part of a global industry, we have been actively engaging with our European and international counterparts, as well as many other stakeholders, over several years to increase clinical trial transparency. This study marks an important step, and we fully expect to see the trend towards greater transparency continue on this positive trajectory."
The ABPI is committed to undertake compliance monitoring for products launched in 2012 and 2013 and has also made available a new clinical trial disclosure toolkit to assist companies.
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Notes to Editor
1These figures include industry-sponsored completed trials in patients from all sources and removing duplicates and exclusions.
Rationale for study
In December 2012, amid continuing concerns and publicity around the transparency and disclosure of clinical trial information, and a year after the Health Research Authority was created in the UK to protect and promote the interests of patients and the public in health research, the House of Commons Select Committee on Science and Technology announced an inquiry into clinical trials and disclosure of data. The ABPI initiated this study in light of the variation in reported disclosure rates, and in response to the call for evidence in the House of Commons Select Committee on Science and Technology inquiry.
Industry progress towards greater transparency
The pharmaceutical industry is committed to greater transparency in clinical trial information, in particular, around the occurrence and results of clinical trials.
We recognise that access to information in clinical study reports and patient level datasets may provide important opportunities to conduct future research that can help advance medical science or patient care.
The ABPI has been actively engaged on this issue. So far this year it has:
• Commissioned an independent third party to monitor member compliance with the standards referred to in the ABPI Code of Practice
• Published an online clinical trial transparency toolkit to provide good practice guidelines, compliance checklists and template standard operating procedures for pharmaceutical companies.
• Given oral and written evidence to the House of Commons Science and Technology Committee inquiry into clinical trials
• Run a stakeholder workshop to explore definitions and guiding principles to enhance transparency in clinical trial reporting. A follow up stakeholder workshop is taking place later this month.
In addition to UK activity, in July, the European-wide and US pharmaceutical industry bodies released ‘Joint Principles for Responsible Clinical Trial Data Sharing’ which seek to support companies in making additional information available to the public, patients who participate in clinical trials, and to qualified researchers. The principles can be viewed here.