Human research is governed by legislation that distinguishes between different categories. These categories are mainly distinguished by the type of intervention envisaged in the research protocol (whether it changes the usual care of participants) and by the level of risk and burden for those who agree to participate. In this article, you will have more information.
The clinical research network has conducted large-scale clinical trials to evaluate the efficacy and safety of new medical treatments. Intervention research is research that involves an intervention for patients or research participants. Unlike non-interventional research, interventional research involves changes in patient care or the introduction of new treatments. Interventional studies are used to evaluate the effectiveness and safety of new drugs, medical devices, behavioral therapies, and surgical procedures. Interventional studies take many forms, including randomized, blinded, double-blind, and adaptive clinical trials. In a randomized clinical trial, participants are randomly assigned to either a treatment or control group.
Intervention studies with minimal risk and burden
Minimal risk and burden intervention trials are trials that involve interventions for patients or trial participants but are considered to have minimal risk or burden to participants. These trials are usually designed to evaluate interventions that have already been approved for use in humans or are considered safe. Intervention trials with minimal risk and burden may include trials of drugs, medical devices, surgical procedures and behavioural therapies. In these trials, participants are usually randomly assigned to either a treatment or control group, and researchers compare the results between the two groups.
Non-interventional studies are studies that do not involve any intervention for patients or research participants. Unlike intervention studies, they do not change the treatment of patients or add new treatments. Non-interventional studies are used to investigate the relationship between risk factors, environmental exposures, or genetic characteristics and patients' health. Non-interventional studies can take many forms, including observational studies, cohort studies, case-control studies, and epidemiologic follow-ups. In observational studies, researchers observe patients without changing their treatment.