Roche trials database

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

• Brief title

  Protocol title of the clinical trial intended for the lay public.

• Protocol number

  A unique identification 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 sponsoring organization(s) that initiated the clinical investigation and which takes responsibility for the clinical trial.

• Brief summary

  A short description in lay terms of the primary purpose of the clinical trial.

• Official Scientific Title

  Official name of the trial in scientific terms provided by the study principal investigator or sponsor. This title contains the following elements: intervention name, condition, and outcome.

• Study phase

  See "Phase Definitions" section of this website. Study phases are not applicable to Diagnostic clinical trials.

• Study type

  Nature of the investigation; either "interventional" - experimental studies in humans to investigate the safety and/or efficacy of a new drug or treatment, or "observational" - studies in humans that record specific events occurring in a defined population without any intervention by a researcher (such as psychosocial studies).

  For interventional studies the following terms are used for describing the investigative techniques:

  • Purpose: describes the rationale of the protocol, using the following terms:
    • treatment: protocol evaluates intervention(s) for treatment of disease, syndrome or condition;
    • prevention: protocol evaluates intervention(s) for preventing development of disease or condition;
    • diagnosis: protocol evaluates intervention(s) aimed at identifying disease and condition;
    • educational/counseling/training: protocol evaluates intervention(s) in an educational, counseling or training environment.
  • Allocation: describes patient selection for intervention assignment, using the following terms:
    • randomized: study participants are assigned to treatment / control groups by chance;
    • non-randomized: study participants are assigned to treatment / control groups explicitly.
  • Masking: describes the knowledge of investigators and study participants regarding the intervention assignment, using the following terms:
    • open label: investigators and study participants know intervention assignment;
    • single blind: investigators are aware of intervention assignment, study participants not;
    • double blind: investigators and study participants are unaware of intervention assignment.
  • Control: describes nature of comparison, using the following terms:
    • placebo: study participants may receive placebo throughout study;
    • active: study participants may receive a different treatment than treatment under investigation throughout study;
    • uncontrolled: no controls are used in study.
  • Assignment: describes how interventions are given to study participants, using the following terms:
    • single group: all study participants receive same intervention;
    • parallel: study participants receive one intervention during the study;
    • crossover: study participants may receive different interventions sequentially during study;
    • factorial: study participants may receive different numbers of interventions during study ranging from none to multiple;
    • expanded access: A study which provides life-saving drugs which may still be in clinical trials to people who need immediate access to them.
  • Endpoint: describes overall outcome that the protocol is designed to investigate, using the following terms:
    • safety: evaluation of safety profile of intervention under proposed use;
    • efficacy: measurement of effect of intervention on a disease / condition;
    • safety/efficacy: combination of safety and efficacy endpoints;
    • pharmacokinetics: study of the effect of the body on a drug, in terms of absorption, distribution, metabolism and excretion;
    • pharmacodynamics: study of the effects of a drug and its mechanism of action in the body over time;
    • pharmacokinetics/dynamics: combination of pharmacokinetics and pharmacodynamics endpoints.

• Overall study status

  Current status of progress from initiation to completion of the clinical trial. Different status stages are defined as:

  • Not yet recruiting: participants in clinical trial are not yet being recruited or enrolled in any site;
  • Recruiting: participants in clinical trial are currently being recruited and enrolled in at least one site;
  • No longer recruiting: participants in clinical trial are no longer being recruited or enrolled in any site;
  • Completed: participants in clinical trial are no longer being recruited; data analysis is complete;
  • Suspended: recruiting or enrolling participants in clinical trial has halted but potentially will resume;
  • Terminated: recruiting or enrolling participants in clinical trial has halted and will not resume.

  Please note that the overall study status is updated on a monthly basis.

• Condition

  Primary diseases or conditions being studied.

• Intervention type

  Type of intervention being used in study, from the following selection:

  • Drug;
  • Gene Transfer, including gene transfer and recombinant DNA (e.g., human nerve growth factor);
  • Vaccine;
  • Behavior (e.g., protein and calorie controlled diet);
  • Device (e.g., defibrillators);
  • Procedure (e.g., adenoidectomy).

• Primary outcome

  The measure or observation which is most clinically relevant to determine the effect of the intervention on key variables in the study.

• Key secondary outcomes

  Other measures or observations to determine the effect of the intervention on key variables in the study.

• Eligibility criteria

  Summary of criteria required for participation in the clinical study.

• Gender

  Gender eligibility for participating in study, male, female or both.

• Age limits

  Minimum and maximum age limits for participants in the clinical study.

• Accepts healthy volunteers

  Yes or No - answers question as to whether individuals who do not have the conditions or symptoms being studied may participate in the clinical trial.

• Study start date

  Planned beginning of enrollment.

• Trial registration date

  Date when study information was submitted to the trial registry for publication.

• Date last updated

  Time stamp indicating when information on the website was last updated. Every effort will be made to keep the information up to date.

• Facility information

  Location information on organizations conducting clinical trials. Please note that the facility information is updated on a monthly basis.

• Contact information

  Email service provided to users who desire more information on specific clinical trials in the protocol registry.