EU Regulation on Clinical Trials: Further enhance clinical data transparency

Open Letter | 11 October 2013 | Download PDF

EU Regulation on clinical trials: further enhance clinical data transparency

A clear stance by the Council in favour of freedom of information for European citizens and of public access to clinical trial data is needed.

Selective publication of only those results which favour the drug in question biases scientific analysis, Medicines Agencies’ decisions and clinical decision making, therefore putting public health at risk and wasting resources of Member States’ healthcare systems (a). Moreover, it is an unethical practice contrary to the Helsinki Declaration and to the basic scientific and political principle of transparency, and it calls for a political answer (b).

On 29 May 2013, the Environment, Public Health and Food Safety (ENVI) Committee adopted a perfectly reasonable demand in order to finally allow for independent analysis of clinical trials: that clinical data contained in clinical study reports (CSRs) “should not be considered commercially confidential once a marketing authorisation has been granted or the decision-making process on an application for marketing has been completed” (amendment 30, creating a new recital).

This demand is in line with the European Medicines Agency policy on access to documents (1) and with the position of the European Ombudsman who found that clinical study reports (CSRs) do not contain commercially confidential information or personal data (participants’ clinical data are previously anonymised) (2). This was confirmed by an in-depth analysis of 78 clinical trials by two researchers from the Cochrane Collaboration in early 2013 (3) (c).

However, since the beginning of the discussions, the pharmaceutical industry has been fighting heavily against citizens’ freedom of information right:
– In March 2013, two pharmaceutical companies, AbbVie and InterMune, supported by European and US pharmaceutical industries trade associations (EFPIA and PhRMA), brought cases against the EMA and its 2010 access to document policy at the European Court of Justice (d) (4);
– In July 2013, EFPIA and PhRMA proposed deficient and non-binding self-regulation principles that would maintain the status quo and are unlikely to be implemented by their members (no access to clinical study reports, demands for applications to be reviewed by a “scientific board” to be appointed by the company in question);
– In addition, in July 2013, EFPIA and PhRMA have made concrete proposals for a lobbying strategy that entailed “mobilising patient groups to express concern about the risk to public health by non-scientific reuse of data” (5).

Throughout the trilogue negotiations, a clear stance must be adopted by the Council, in favour of freedom of information for European citizens. This is necessary in order to ensure that the new Regulation on clinical trials will advance public access to clinical trial data, and will be of benefit to the public at large.

We therefore ask you to support Amendment 30 of the ENVI report, and also to add this requirement to the Regulation, in the form of an article. This would also enable the European Medicines Agency to defend itself in the procedure brought before the EU Court of Justice by the two companies challenging its 2010 policy on access to documents.

We also moreover ask you to further strengthen transparency requirements by demanding the publication of clinical study reports (CSRs) (e), within 1 year from the end of the clinical trial, and at the latest within 3 years if the company has not by then applied for marketing authorisation, to ensure that these results are not forever lost to science should the company decide in the end not to seek marketing authorisation.

Clinical trials should also aim to determine how well patients tolerate new medicines. The Regulation only requires the reporting of serious adverse drug reactions by the trial sponsor to the Agency if they are “unexpected”. Yet recent evidence suggests companies are reluctant to their drugs’ adverse reactions to health authorities (6).

We urge you to demand reporting by the investigator (the clinician) of all serious adverse reactions, whether “expected” or not, via the centralised portal, in order to avoid harmful delays in the decisionmaking process, especially when urgent measures are needed to protect participants. We would be happy to further discuss this issue with you, as well as that of participants’ protection (read in annex 1), and hope that you will be able to take our recommendations into account.

Association Internationale de la Mutualité (AIM), Medicines in Europe Forum (MiEF), Nordic Cochrane Centre, TransAtlantic Consumer Dialogue (TACD), Health Action International (HAI) Europe, WEMOS, International Society of Drug Bulletins (ISDB)

a. In Europe, in 2009, several EU governments stockpiled millions of doses of Tamiflu° to combat A/H1N1 influenza, even though the effectiveness of Tamiflu° in the prevention of influenza complications was unproven, so wasting billions of euros. Health authorities made decisions without seeing the full data set (ref. 2).
b. See the AllTrials Campaign (, as well as other campaigns ( calling for access to clinical trials results. Clinical trials data are scientific data and should be open to scrutiny by independent parties (for more information, read “Debunking 4 secrecy myths which hinder transparency” here:
c. Moreover, in a recent study, the German health technology agency IQWIG showed that in contrast to CSRs, publicly available sources provide insufficient information on patient-relevant outcomes of clinical trials, and called for CSRs to be made publicly available (ref. 7).
d. In an intervention in August 2013, an Abbvie representative explained its opposition to transparency asserting that some adverse drug reaction data should be considered commercially confidential (ref. 8). At the end of September, the media reported that the former CEO of InterMune is in home detention as part of a six-month penalty for exaggerating the benefits of one of the firm’s product… (ref. 9).
e. Clinical study reports are comprehensive documents containing the following sections: report synopses (about 5 pages), efficacy evaluation (about 13 pages), safety evaluation (17 pages), trial protocol (about 60 pages), and the remaining pages are attached tables and anonymised individual efficacy and safety listings (ref. 8).

1. “Draft policy 70: Publication and access to clinical-trial data” 24.06.2013.
2. Gøtzsche PC. “Opening up data at the European Medicines Agency” BMJ 2011, 342:d2686
3. Doshi P et Jefferson T “Clinical study reports of randomised controlled trials: an exploratory review of previously confidential industry reports” BMJ Open 2013;3:e 002496.
4. Dyer C “European drug agency’s attempts to improve transparency stalled by legal action from two US drug companies” BMJ 2013; 346:f3588.
5. Sample I “Big pharma mobilising patients in battle over drugs trials data – Leaked memo from industry bodies reveals strategy to combat calls by regulators to force companies to publish results” The Guardian, Sunday 21 July 2013.
6. There are many examples, well documented, e.g.: – Healy D “Let them eat Prozac” New York: New York University Press, 2004. – Gøtzsche PC. Deadly medicines and organised crime: How big pharma has corrupted health care. London: Radcliffe Publications, 2013. – “GlaxoSmithKline to plead guilty and pay $3 billion to resolve fraud allegations and failure to report safety data”. July 2012. 3 pages. – “European Medicines Agency acts on deficiencies in Roche medicine-safety reporting”. July 2012. 2 pages.
7. Wieseler B et coll. “Completeness of Reporting of 7-Relevant Clinical Trial Outcomes: Comparison of Unpublished Clinical Study Reports with Publicly Available Data” PLoS Med 2013; 10(10): e1001526. doi:10.1371/journal.pmed.1001526.
8. Hawkes N “Industry and Drug regulators disagree on which data should remain confidential” BMJ 2013 ; 347: f5390. 9- Brown D “The press-release conviction of a biotech CEO and its impact on scientific research” 23 September 2013.