About Clinical Trials
Results Database Field Definitions
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 .
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.
List of key publications associated with the results of the clinical trial.
- Phase of development:
See "Phase Definitions" section of this web site.
A summary of the primary and secondary objectives of the clinical study.
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.
Scientific summary of the results from the clinical trial. Can include efficacy, safety, pharmacokinetic and other results.
Conclusions supported by the results of the clinical trial.
- Date of report:
Date the clinical study report was completed.