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Deferred public disclosure

Public disclosure of sponsor and Member State (MS) documents and data (except data and documents related to Quality, like for instance the Q-section of the IMPD) in the public database of CTIS takes place at the time of the decision by the MSC, unless the sponsor requested for a deferral of the public disclosure at the initial application when registering the clinical trial in CTIS (see chapter 9 CTIS sponsor handbook).

This deferral is based on the clinical trial category. No deferral is  possible for the main characteristics of the clinical trial, conclusion part I, conclusion part II, outcome and date of decision on clinical trial, start and end dates and temporary halt. An overview of the timing of publication of data and documents in public portal of CTIS in relation to the category of the trial is given in table 1 of the disclosure rules document. There are three categories of clinical trials (based on the use and status of their IMPs) for which the first category can have the longest deferral. Where a clinical trial protocol sets out a multiphase or adaptive study design that falls in both category 1 and 2, the trial will be treated according to the higher of the potential designations.

Category 1 clinical trials (pharmaceutical development clinical trials)

  • Phase 0 clinical trials.
  • Phase I clinical trials.
  • Bioequivalence and bioavailability trials of innovative products, new generic products and bio-similar products. This includes such trials on new formulations of products with a marketing authorisation (originator, generic or bio-similar).
  • Similarity trials for bio-similar products including those conducted in patients where efficacy endpoints are used to determine bio-similarity, where pharmacokinetic and or pharmacodynamic studies are not possible.
  • Equivalence trials for combination products or topical products where a pharmacodynamic or efficacy endpoint is used to determine equivalence, and where pharmacokinetic and or pharmacodynamic studies are not possible.

Category 2 clinical trials (therapeutic exploratory and confirmatory clinical trials)

  • Phase II and III clinical trials.

Category 3 clinical trials (therapeutic use clinical trials)

  • Phase IV clinical trials
  • Low-intervention clinical trials.