Understanding if your study is a clinical trial is an important first step. The World Health Organisation defines a clinical trial as ‘any research study that prospectively assigns human participants or groups of humans to one or more health-related interventions to evaluate the effects on health outcomes’. These may include patient, family, care-provider or community level interventions. Clinical trials may test new or existing interventions or observe how people respond to other factors that may affect their health.
Clinical trial interventions include but are not limited to:
You can use this decision tree to decide if your study is a clinical trial.
Reference: NIH Central Resource for Grants and Funding Information, Clinical Trials Decision Tree
You want to develop your own idea for a trial, but don’t have a pre-existing protocol, funding or a sponsor yet.
You have been approached by an industry sponsor, another academic group or a cooperative research group to be an investigator on their trial to open in your site. This part of the Roadmap will take you to ethics approval and execution of your sponsor’s agreement.