GSK Official Supports 'Lockbox' Approach to Publishing Trial Data

The proliferation of clinical trial registries has started raising red flags among drug companies, some of which are starting to express concerns that making all clinical data publicly available will leave valuable trade secrets exposed.

Some requirements for trial registration -- particularly those of the International Committee of Medical Journal Editors (ICMJE) -- threaten to disclose proprietary drug information that could allow competitors access to key information, drug industry officials contend. Composed of a group of medical journal editors, ICMJE recently established strict guidelines for the format of manuscripts submitted to its publications.

One way firms may be able to meet the ICMJE requirements while still protecting proprietary information is using a "lockbox" approach for trial registration, Ronald Krall, senior vice president of worldwide development at GlaxoSmithKline, said at the recent Clinical Trials Congress in Philadelphia.

Krall acknowledged that the disclosure of certain information required by the ICMJE provides assurances that trials aren't being manipulated, but he warned that the information also provides data on development strategies and marketing timetables that could be used by competitors. The data points that are of particular concern, he said, include information on new chemical entities, key trial progress dates and the target number of subjects.

Rather than make sensitive data available to the public during clinical development, Krall would like to see a lockbox approach utilized in which the ICMJE receives the required information at the time of trial initiation, but doesn't make it publicly available until after the drug is approved.