Trial type refers to the nature of the investigation. The CTRP includes the following types:
- Interventional. Studies in human beings in which individuals are assigned by an investigator based on a protocol to receive specific interventions. Subjects may receive diagnostic, therapeutic or other types of interventions. The assignment of the intervention may or may not be random. The individuals are then followed and biomedical and/or health outcomes are assessed.
- Non-Interventional. Studies in human beings in which biomedical and/or health outcomes are assessed in pre-defined groups of individuals. Subjects in the study may receive diagnostic, therapeutic, or other interventions, but the investigator does not assign specific interventions to the subjects of the study.
The non-interventional category includes observational and ancillary/correlative studies:
- Observational. Studies among cancer patients and healthy populations that involve no interventions or alteration of the participants. Biomedical and/or health outcome(s) are assessed in pre-defined groups of participants. The participants in the study may receive diagnostic, therapeutic, or other interventions but the investigator of the observational study is not responsible for assigning specific interventions to the participants of the study.
- Ancillary-Correlative. A trial that is secondary to another trial, or a type of trial that tests for a relationship between a condition and a potential causal factor of the condition.
- Ancillary. Studies that are stimulated by, but are not a required part of, a main clinical trial/study, and that utilize patient or other resources of the main trial/study to generate information relevant to it. Ancillary studies must be linked to an active clinical research study and should include only patients accrued to that clinical research study. Report only those studies that can be linked to individual patient or participant data.
- Correlative. Laboratory-based studies using specimens to assess cancer risk, clinical outcomes, response to therapies, etc. Report only those studies that can be linked to individual patient or participant data.
