Glenis Willmott MEP (S&D, UK) took the initiative to bring together experts to discuss the extent to which more transparency could be workable in non-commercial clinical trials. The debate, which took place in the European Parliament on 10 April, served to present the key arguments for and against increased transparency in the context of administrative and data reporting requirements for academic researchers and patient safety.
EPHA’s Position on Clinical Trials urges political decision makers to make available as much information as possible when it comes to trial results (ie. full results rather than summaries), as clearly, more information will help to avoid duplication of work (and hence make savings on research), save patients’ lives, and enable stratified data analyses by researchers and other parties.
As Peter Gotzsche of the Nordic Cochrane Centre (Denmark) highlighted, there can be potentially harmful consequences of not knowing trials results. Moreover, results can be skewed, through selective reporting in trial summaries. He also pointed to the importance of knowing potential side effects for people on combination therapies. He argued that wasting resources on repeating trials already conducted also stifles innovation, and so he welcomes the European Medicine Agency’s new stance in favour of providing comprehensive information, including raw data.
Teresa Alves of independent drugs bulletin Prescrire also mentioned the Joint Open Letter ”Protect Public Health: Choose Transparency! co-signed by 11 EU or international organizations including EPHA members AGE, EATG, and HAI Europe.
David Hammerstein of the Transatlantic Consumer Dialgue added that reliance on media reporting for certain medicines creates non-compliance with drug treatments amongst patients, as they don’t have access to better information and often abandon their treatments out of uncertainty. He reminded participants that drugs are the third most common cause of death in the EU and urged political decision makers to ‘’leave behind the dark ages of secrecy’’.
In the context of the Commission’s proposal for a Clinical Trials Regulation and MEP Willmott’s report released in January 2013, the meeting represented an exchange of views between parties advocating for full transparency and those in favor of a middle ground (i.e. providing a summary of trials results plus a master file and/or additional documents as necessary). A number of university representatives expressed worries about additional administrative, budgetary and human resource burdens related to providing raw data of trial results in the required format. Some stated that this would be especially difficult for small study groups that could not afford hiring expert data managers able to present the information correctly. Hazel Baird of the NHS Foundation also mentioned concerns about patient confidentiality, breach of anonymity and consent which had been identified as barriers to full transparency in the UK’s current framework guiding clinical trials.
Anastassia Negrouk of the European Organisation for Research and Treatment of Cancer cautioned that if data were freely available to the public, the risk to both patients and to public health could be high as individuals and groups could potentially be identified through coded data. In her opinion, access should thus be proportional to risk (especially in off label settings), data protection rules must always be respected, and data users must be obliged to declare their intentions to avoid misuse and breaches of confidentiality.
Trish Groves of the British Medical Journal stated that academics tend to sit on their data for too long as sharing may not always be beneficial for their career development. However she reminded the audience of the requirements enshrined in the Helsinki Declaration, notably the need to provide complete, accurate and balanced results. She argued in favour of ‘’open but controlled access’’, which could offer a potential solution to the problem.
As a middle ground solution, Peter Gotzsche proposed an approach where less data would be required in the full report in order to reduce administrative burden; he stated that the ICH-CSR guidelines were too comprehensive.
For further information:
– European Commission, DG Health & Consumer Policy – Clinical Trials
– Health Action International – Europe
– Transatlantic Consumer Dialogue
– Nordic Cochrane Centre
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