Intended for healthcare professionals

Rapid response to:

Observations Open Data Campaign

Open letter: European Medicines Agency should remove barriers to access clinical trial data

BMJ 2014; 348 doi: https://doi.org/10.1136/bmj.g3768 (Published 06 June 2014) Cite this as: BMJ 2014;348:g3768

Rapid Response:

Re: Open letter: European Medicines Agency should remove barriers to access clinical trial data

We write on behalf of a team that has taken on the task of rewriting GlaxoSmithKline’s Study 329 of paroxetine in adolescents under the RIAT (restoring invisible and abandoned trials) project (http://www.bmj.com/content/346/bmj.f2865).

Our RIAT team was granted access to the Data from Paxil Study 329 to do an independent reanalysis by GSK, and we've now had months of experience working with their "remote desktop" interface as a portal to their information. It is a single windowed multiple document interface, totally self contained that can't be accessed by any software other than that provided inside the window. Multiple passwords are required multiple times for access, and on some days, one is frequently thrown from the system without warning, necessitating repeated logins. There's another internal window from SAS that contains the data and allows one to run SAS programs to analyze the data. The data is also provided as text-based CSV files that can be moved outside the internal SAS window and displayed in spreadsheets [Open Office is provided]. The open source statistical program, "R" is also provided. In our case having no-one fluent in SAS procedures and programming, we are using "R" which has the necessary statistical functions. Getting the data into the proper format required by "R" means using multiple spreadsheets - which is very difficult in the cramped space provided - sometimes taking days and involving many "start-overs." Once the data is analyzed, one can only export non-data containing files with results, and that's only by application for approval. Using the primitive graphing functions of Open Office or "R' in the "remote desktop" is very difficult and the graphs can't be exported. That finally lead us to copy the information for the graphs by hand to get it into the computer proper to create our images. The process of using this interface for analysis is unnecessarily maddening and a severe obstruction to the task.

The original hand written CRFs are provided as PDF documents. In our case, there are some 275 subjects, many with several pdfs, each pdf containing 200+pages. In the interface provided, we can see only one page at a time of the nearly 60,000 pages. Tallying the adverse events from the pdfs is hard enough work, but doing to without being able to make printed copies and referring back and forth is a double nightmare, requiring days of wasted time, and delegation is impossible. Working inside of this little window brings home how important it is to have a workspace that allows simultaneous display of lots of information, and this isn't it. One of our team has lost one assistant already over this interface. The EMA's decision to even consider using this kind of interface is, at best, ill advised, and a negation of the initial promise of Data Transparency. If we didn't have a retired member and some members with assistants, we couldn't do it. It is impossible to imagine that anyone contemplating this decision who knows the ins and outs of data analysis has tried it out in this kind of environment. We would liken it to going to sea to see the world in a submarine, looking through a periscope.

Competing interests: No competing interests

10 June 2014
Jon N Jureidini
Child psychiatrist
John M. Nardo
University of Adelaide
PMHTU, 55 King William Road, North Adelaide, 5006, Australia