1 Boring Old Man

The release of regulatory documents under EMA policy 0070: Now you see them, now you don’t

British Medical Journal

by Khaled El Emam, Tom Jefferson, and Peter Doshi

15 Sep, 2015

The European Medicines Agency (EMA) has issued its long anticipated new policy (policy 0070) on prospective access to clinical trial data, and is now in consultations to figure out the details of its implementation. We were invited to join these ongoing consultations, and have previously reported on the debate here and here.

We have been particularly concerned about the anonymization and redactions of the content of clinical study reports (CSRs), and especially concerned about the approach proposed by some in industry.

But now we are getting really worried. Current drafts of the EMA’s evolving guidance documents for the anonymization of CSRs leave too much leeway for creative interpretation of acceptable anonymization practices, and an EMA follow-up meeting on 7 September made clear that some industry associations are pressing to apply a standard known as the TransCelerate approach. While almost all approaches sound reasonable (after all, they are intended to protect the anonymity of trial participants—a good thing), the TransCelerate redaction approach would cripple the usefulness of CSRs.

Take a look for yourselves. Figure 1 (below) is a page from a Tamiflu CSR (Research Report No. 1005291) that Roche released to us after a four year long battle for access. Figure 2 shows what would be likely to happen if Roche applied the TransCelerate redaction standard to that same document. Applying the TransCelerate approach takes the Tamiflu document and turns it into a page of black boxes. For instance, all dates relating to individual trial participants have to be redacted, as well as other patient information such as sex, age, weight, height, race, ethnicity, and socioeconomic information. All patient narratives would also have to be removed.

[see figures linked above]

Figure 1: Line listing from Tamiflu trial WV16277 (Research Report No. 1005291) redacted by Roche for public release. Available from http://dx.doi.org/10.5061/dryad.77471

Figure 2: Line listing from Tamiflu trial WV16277 (Research Report No. 1005291) redacted according to the TransCelerate guidance. Available from http://dx.doi.org/10.5061/dryad.77471

Why “likely to happen” and not “happen”? Because we had to create figure 2 ourselves. Ideally, those advocating a redaction approach would send around shared examples for the rest of us to see and discuss. But there were no clear examples at the EMA meetings.

Using redactions to assure the anonymization of data in CSRs is emerging as a make or break issue for the success of the EMA initiative. The intensive redaction of the TransCelerate approach risks nullifying most of the progress towards transparency made so far in Europe…

It seems to me that the history of Clinical Trials of drugs is not unlike the stories told by many of our patients with personality disorders – the solution to the last problem is the beginning of the next problem. With the trials, the last reform movement creates the loophole that allows things to essentially remain as dysfunctional as they’ve always been. Right now, we’re committed to Data Transparency, and we’re now watching is be picked apart in front of our eyes. The watchdogs on the byline here are front and center on the case along with others, but they may be like the little Dutch Boy, running out of fingers to stick in the leaks.