Who can participate in clinical trials?
By design, there are no restrictions on who can participate in a clinical trial. However, for ethical reasons, and most importantly for safety reasons, studies are not conducted on pregnant women.
The majority of clinical trial participants are adults who are fully informed and can be responsible for their decisions and are legally able to act.
A minority of clinical trial participants are over 65 years of age due to the fact that with age decreases the capacity of organs involved in proper absorption, distribution, metabolism and elimination of the drug, and these parameters are evaluated in clinical trials to estimate and select the best possible therapeutic dose.
The practice also conducts pediatric clinical trials in which the legal guardian is involved in the process of obtaining informed consent.
The inclusion and exclusion criteria in the study protocol detail who can participate in a particular research project. This document defines who may have a chance to qualify for the study i.e. gender, age group, health status. The final eligibility decision is made after the investigator has assessed whether the participant meets all the inclusion criteria required by the protocol, and also does not meet any of the exclusion criteria.