Yesterday’s announcement that the EMA Management Board may have adopted a less obstructive policy to releasing clinical trial data comes hard on the heels of widespread coverage (see here, here, here, and here) and protests (by the EU Ombudsman, us, us again, Trudo Lemmens, the ISDB/AIM/ Nordic Cochrane Centre/ Medicines in Europe Forum, German IQWiG, and AllTrials). All this, plus a Twitter #screenonly campaign, reveals enormous discontent with the agency’s last minute announcement of “view on screen only” access to clinical study reports (CSRs), new “redaction principles,” and new legal “terms of use.”
In two responses, EMA executive director Guido Rasi defended the agency’s draft policy, explaining that the EMA’s latest draft policy represented “absolutely no change in direction.”
Yesterday’s press release from the EMA announces “more user-friendly amendments proposed by EMA executive director Guido Rasi, that will not only allow the Agency to proactively publish clinical trial data that are submitted as part of marketing authorisation applications, but also give the possibility to download, save, and print the trial data for academic and non-commercial research purposes.”
This appears, on the face of it, to be another major change by the agency, effectively doing away with the peeping tom policy proposal to look, but not touch the material.
However, we urge those who are about to rush to the nearest off-licence and purchase some champagne, to bide their time, and wait until we see the fine print of the policy.
Firstly, even if the “view on screen only” policy has been removed, serious concerns remain about the EMA’s redaction and terms of use policies.
Secondly, we’ve had surprises sprung on us before. Things looked good before the EMA’s sudden “u-turn” in the middle of May. Last week, Rasi told AllTrials that “the issue of the usefulness of on-screen access to data was discussed with academics during the whole consultation process and we do not accept that this is a superficial or useless gesture.” Yet the peeping tom clause came as a surprise to those attending the EMA’s 16 May meeting with academics. Furthermore, many of the researchers who had formally contributed to earlier EMA committee work in 2013 do not appear to have been invited to this final meeting, for reasons as yet unexplained. (A letter, co-signed by Peter Doshi, was sent to Rasi requesting an explanation.)
On this basis, we feel that Ronald Reagan’s old maxim “trust but verify” is more appropriate than celebrations.
Tom Jefferson, reviewer, Cochrane Acute Respiratory Infections Group, 00187, Roma, Italy.
Peter Doshi, assistant professor, Department of Pharmaceutical Health Services Research, University of Maryland School of Pharmacy, Baltimore, MD 21201, USA.
Competing interests: TJ and PD are co-recipients of a UK National Institute for Health Research grant (HTA – 10/80/01 Update and amalgamation of two Cochrane Reviews: neuraminidase inhibitors for preventing and treating influenza in healthy adults and children—http://www.nets.nihr.ac.uk/projects/hta/108001).
In addition:
PD received €1500 from the European Respiratory Society in support of his travel to the society’s September 2012 annual congress in Vienna, where he gave an invited talk on oseltamivir. Dr Doshi is also an associate editor of The BMJ.
TJ receives royalties from his books published by Blackwells and Il Pensiero Scientifico Editore, Rome. TJ is occasionally interviewed by market research companies for anonymous interviews about Phase 1 or 2 pharmaceutical products. In 2011-2013, TJ acted as an expert witness in a litigation case related to oseltamivir phosphate; Tamiflu [Roche] and in a labour case on influenza vaccines in health care workers in Canada. In 1997-99 TJ acted as consultant for Roche, in 2001-2 for GSK, and in 2003 for Sanofi-Synthelabo for pleconaril (an anti-rhinoviral which did not get approval from FDA). TJ was a consultant for IMS Health in 2013, and is currently retained as a scientific adviser to a legal team acting on the drug Tamiflu (oseltamivir, Roche).