Roche trials database

A summary of the results of a clinical trial entered into the Roche results database will typically include the following fields:

• Title of study:

  Study title as captured in the synopsis of the clinical study report.

• Protocol number:

  A unique identification number assigned to a Roche sponsored trial. Each study has a unique number. Even if multiple studies are conducted using the same drug or diagnostic product, they will each have a unique number. A trial published in both the trial registry and the results database will have the same protocol number .

• Sponsor:

  Name of the sponsoring organization(s) that initiated the clinical investigation and which takes responsibility for the clinical trial.

• Product name:

  Common name for the product being tested in a clinical trial.

• Generic name:

  Precise generic name of the product being tested in a clinical trial.

• Therapeutic area or approved indication:

  Targeted disease area for the clinical trial and/or indication(s) for which the drug has been approved for use.

• Clinical study summary:

  Scientific summary of the study.

• Study center(s):

  Summary of study centers taking part in the clinical trial.

• Publications:

  List of key publications associated with the results of the clinical trial.

• Phase of development:

  See "Phase Definitions" section of this web site.

• Objectives:

  A summary of the primary and secondary objectives of the clinical study.

• Methodology:

  A scientific summary of the methodology used to conduct the clinical trial.

• Number of patients (planned/analyzed):

  Number of planned and analyzed patients in the clinical study.

• Diagnosis and main criteria for inclusion:

  Description of the diagnosis and other main criteria for the inclusion of participants in the clinical study.

• Test product, dose and mode of administration or test procedure:

  Description of product tested, dose level and mode of administering the product, or a description of the test procedure.

• Duration of treatment:

  Length of time associated with treatment in the clinical trial.

• Reference therapy, does and mode of administration or reference procedure:

  Description of the reference therapy, dose and mode of administering that therapy if applicable, or a description of the reference procedure.

• Criteria for evaluation:

  Scientific criteria used to evaluate the outcomes of the clinical trial. Can include efficacy and safety criteria.

• Statistical methods:

  Summary of the statistical methodology used to evaluate data from the clinical trial.

• Summary:

  Scientific summary of the results from the clinical trial. Can include efficacy, safety, pharmacokinetic and other results.

• Conclusions:

  Conclusions supported by the results of the clinical trial.

• Date of report:

  Date the clinical study report was completed.