What is clinical research?
Clinical research involves studies which leads to collection of valuable data which helps us to determine whether a new investigational drug or a medical device is safe and effective to use for the treatment of a disease or a medical condition.
Several stages are involved and required for the development and approval of a drug or a device for use in humans. With a background of probably several years of successful laboratory research, a product will then need to be tested and clinical research is the only way to determine the safety and efficacy in humans before it can be used for treatment purposes with minimal side effects.
How are clinical studies conducted?
Clinical studies are carefully, specifically and comprehensively designed research studies to investigate how a medicine/medical device works and to prove that it is safe and effective to use in humans. The studies are carried out under strict regulatory and ethical recommendations to protect the rights of participants and need to be approved by appropriate ethical authorities and will undergo quality check throughout the course of the study.
At all stages of a clinical trial, and for a certain period of time after completion, it is absolutely necessary to ensure the safety and health of those who participate in the study. Each study has its own unique eligibility criteria and addresses specific research questions. Participants who fulfil the eligibility criteria are selected for a study and the effect of a drug or a medical device is monitored for a certain period of time.
To learn how a new product works, physicians and medical experts closely evaluate the changes in health of the participants and also any possible side-effects. Clinical studies are also performed to compare two existing treatments or interventions or to evaluate and identify side effects of an already established medical treatment or a pharmaceutical agent.