A study assessing clinical trial transparency, published in 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, 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 a European Public Assessment Report (EPAR) relating to all new medicines approved by the European Medicines Agency (EMA) over three years, from 2009 through 2011. In this period, there were 997 evaluable trials in patients posted across all registries and databases, relating to 53 new medicines. From this information, an assessment was undertaken on the disclosure of results of clinical trials conducted in patients and sponsored by pharmaceutical companies for new medicines recently approved in Europe.
The key findings showed 76% of all industry-sponsored clinical trials for new medicines recently approved by the EMA had some results disclosed within a year of completion or of regulatory approval; and rates of disclosure have continued to rise, and 89% of these trials had disclosed results by Jan. 31.
This is thought to be the first study to assess the proportion of industry-sponsored trials for which at least some results were publicly disclosed by searching a range of registries and databases, and/or by publication in scientific literature, without regard to prevailing reporting requirements.
Stephen Whitehead, ABPI chief executive, said, “The ABPI is a strong advocate for transparency in clinical trial data, so it is encouraging to see a distinct upward trend toward 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 also has made available a new clinical trial disclosure toolkit to assist companies.
In Dec. 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 U.K. 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.
In addition to U.K. activity, in July, the European-wide and U.S. pharmaceutical industry bodies released Joint Principles for Responsible Clinical Trial Data Sharing, which seeks to support companies in making additional information available to the public, patients who participate in clinical trials and qualified researchers.