Tribulations and trials: redactions of clinical trial protocols

Balaban and colleagues’ article describes the worsening epidemic of protocols being redacted when published in medical journals.1 They explain that the main excuse for redaction is fear of release of commercially sensitive information or trademarked intellectual property.In the UK the problem is taken one stage further—Freedom of Information Act (FOIA) requests concerning disclosure of clinical trial protocols may be refused by the NHS Health Research Authority (HRA) on the same grounds.HRA defines a protocol as “a full description of your research study. It acts as a manual for the research team at research sites to ensure adherence to the methods outlined.”2 HRA provides some protocol development tools and templates which don’t seek commercially sensitive information.Under the FOIA I asked HRA to see the protocol for ██████████’s NextCOVE vaccine trial.3 HRA declined to supply even a redacted version as it contained “detailed and specific information regarding product development plans … that…
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