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More and more transparency

Last month, the International Clinical Trials Day (ICTD) celebrated the work of James Lind, a surgeon in the British navy who carried out what is now recognised as the first ever clinical trial, by giving scurvy-ridden sailors aboard his ship a combination of different treatments, and with him the importance of clinical trials to lead us towards better treatments for patients.

During the ICTD annual meeting which took place in May 2015 in Tondheim, Norway, the major topic of discussion at was ‘transparency’ in clinical research. It has long since been recognised that informed clinical decisions and hence better patient treatment can only be achieved if doctors have access to the results of all clinical trials, both present and past, with both positive and negative results included.

The last two years have witnessed a number of regulatory and legislative changes to support the publication of clinical trials data. In the EU, a new clinical trials regulation, which will come into force mid-2016, places greater emphasis on transparency, recognising that “Transparency avoids redundancy and duplication. It ensures that even clinical trials with unfavourable results are made public, thereby avoiding ‘publication bias’. Finally, transparency gives patients the possibility to find out about on-going clinical trials in which they may wish to participate[1].

Indeed, the past five years have seen a steady increase in the number of clinical trials being published by industry. The Association of British Pharmaceutical Industry (ABPI) has been tracking disclosure rates of clinical trials for company-sponsored trials and found that since 2009, the disclosure rate has steadily improved from 71% in 2009, to 81% in 2010, 86% in 2011 and 90% in 2012. According to the latest figures [2], of the 340 industry-sponsored trials (completed before the end of January 2014) associated with all 23 new medicines approved by the European Medicines Authority in 2012: 90% had results disclosed on a registry or in scientific literature within 12 months of first regulatory approval or trial completion, and 92% had results disclosed by the end of the study on the 31st of July 2014.

A need for total transparency

However, there is pressure from campaign groups such as ‘All Trials’ to publish full clinical study reports from all clinical trials – past, present and future – on all treatments currently being used [3]. Not having access to all the information about a drug, they explain “…is a serious problem for evidence based medicine because we need all the evidence about a treatment to understand its risks and benefits.” The World Health Organisation (WHO) has recently shown its support by releasing a statement, in which it emphasises that “There is an ethical imperative to report the results of all clinical trials[4]. The WHO recognises that results from past clinical trials still have an important bearing today on scientific research and how doctors treat patients. As a consequence, the WHO are requesting that study findings are submitted to peer reviewed journals and posted on a free-to-access, publicly available clinical trials registry within twelve months of study completion.

Dr Ben Goldacre, one of the founders of the AllTrials campaign, has explained how a central database, rather than peer-reviewed journal publication, may be a better way to display results [5]. In scientific journals, negative results are not often published and the study’s primary outcomes can be modified, explains Dr Goldacre. Research has also found how academic journal reports are inconsistent with the reporting found on sites such as the US National Institute of Health’s clinicaltrials.gov (a registry and results database of publicly and privately supported clinical studies of human participants conducted around the world). Often journal reports contain less complete information on methods, results and adverse effects [6].

Dr Goldacre has suggested that a simple method of auditing may help to improve good practice and ensure companies remain complaint. By recording when results are published, performance metrics for individual companies, funders, drugs, disease areas, institutions, and investigators can easily be deduced. Better scores mean more trust in companies from doctors and patients.

[1] European Commission (2015) Q&A: New rules for clinical trials conducted in the EU. Available at http://europa.eu/rapid/press-release_MEMO-14-254_en.htm [Accessed 04/06/15].
[2] Rawal B & Deane BR. (2015) Clinical trial transparency update: an assessment of the disclosure of results of company-sponsored trials associated with new medicines approved in Europe in 2012. Current Medical Research and Opinion. doi:10.1185/03007995.2015.1047749
[3] AllTrials (2015) The AllTrials Campaign Available at http://www.alltrials.net/find-out-more/why-this-matters/the-alltrials-campaign/ [Accessed 04/06/15]
[4] WHO (2015) WHO Statement on Public Disclosure of Clinical Trial Results. Available at http://www.who.int/ictrp/results/reporting/en/ [Accessed 04/06/15]
[5] Goldacre B. (2015) How to Get All Trials Reported: Audit, Better Data, and Individual Accountability. PLoS Med 12(4): e1001821. doi:10.1371/journal.pmed.1001821
[6] Hartung DM, Zarin DA, Guise J-M, McDonagh M, Paynter R, Helfand M. (2014) Reporting discrepancies between the ClinicalTrials.gov results database and peer-reviewed publications. Ann Intern Med.1;160 (7):477–83.

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The author

Ruth KnowlesRuth Knowles is a freelance science writer who has written articles and press releases on a range of life science and health topics. She received her MSc in Science Communication from the University of the West of England, Bristol.

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