Research study Clinical trials
Many new medicines and treatments are found to be helpful and safe in test tubes and in animals. They must also prove safe and effective in humans before doctors can prescribe them. This testing in humans is permitted only if that person volunteers for participation and understands the risks and benefits of taking part in a study. This informed consent to participate must be based on the volunteer's understanding of what is involved in the study, including potential risks and benefits. Volunteers may leave a study at any time.
This is a collection of clinical studies being conducted by the National Institutes of Health at the National Institutes of Health Clinical Center in Bethesda, Maryland. If you have any questions about participating in a clinical study
What is the Definition of per protocol population in Clinical trial
The analysis can only be restricted to the participants who fulfil the protocol in the terms of the eligibility, interventions, and outcome assessment. This analysis is known as an "on-treatment" or "per protocol" analysis. Also, the per-protocol restricts the comparison of the treatments to the ideal patients, that is, those who adhered perfectly to the clinical trial instructions as stipulated in the protocol. This population is classically called the per-protocol population and the analysis is called the per-protocol-analysis.