13 Jun, 2014The European Ombudsman, Emily O’Reilly, notes the statement EMA published after its management board meeting on 12 June. As EMA now intends to finalise a revised wording for its proactive clinical trial data policy, the Ombudsman cannot yet comment in detail on what may emerge. However, the Ombudsman notes that she shares the grave concerns expressed by members of the scientific community about EMA’s draft disclosure policy. In her view, it was defective on three fronts:
It allowed data only to be seen on-screen using an interface, thereby preventing researchers from downloading the data. According to EMA’s 12 June statement this point seems to be subject to change by "giving the possibility to download, save and print trial data for academic and non-commercial research purposes". If implemented, the Ombudsman would welcome this change.
In 2012, subsequent to a request to release clinical study reports relating to two medicines [Humira and Esbriet], EMA decided to release these clinical study reports with only limited redactions. It recently agreed, as part of a compromise deal with a pharmaceutical company, to make more extensive redactions to the Humira documents. The Ombudsman is currently carrying out an inquiry to determine the legality of those additional redactions. The Ombudsman remains puzzled as to why EMA abandoned its original draft disclosure policy from 2012 and substituted it with a different draft policy, more in line with the pharmaceutical industry’s wishes.
British Medical Journal Blogsby Tom Jefferson and Peter Doshi13 Jun, 2014Yesterday’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.
This is an example of how criticism from the blogosphere can pressure political change. One thing malefactors hate is a chorus of outcry. Congratulations, Dr. Mickey, for adding your voice to the chorus.