World Journal of
Pharmaceutical and Life Sciences

A REVIEW ON TYPES OF CLINICAL TRIAL STUDIES, CLINICAL TRIALS ETHICS, AND ITS IMPACT ON HEALTH CARE RESEARCH

A.Bharath Kumar*, B. Dwarakesh, V.Ananda Deepak

ABSTRACT

A clinical trial is an experimental study that evaluate new medical treatment effectiveness is compared to an existing treatment. Initially all the new drugs must pass into preclinical studies. A preclinical study involves in-vitro studies. Clinical trials consist of four phases that includes Phase I, II,III,IV. Phase I clinical trials studied in a small number of healthy volunteers. The dose level toxicity determined use of multiple statistical designs. Phase II trials conducted in a small number of volunteers who have the illness. The drug level dose, toxicity, dose frequencies, administration, safety, efficacy, and the study endpoint will be determined to start phase III trials. Phase III study is conducted in larger patients to confirm efficacy and to identify the incidence of common adverse reactions. In this phase a sponsor to conduct a phase IV trial as a stipulation for drug approval. Phase IV trials referred to observational studies performed for FDA-approved drugs. There are various types of clinical trials includes experiments and comparative analyses, observational studies, surveys etc. Clinical trials aim to prove the therapeutic effectiveness of a new drug by conducting biological assays, toxicity studies, and pharmacokinetics studies will enhance the drug efficacy. Clinical trials are designed to monitor the new drug outcomes in human subjects. Randomization is commonly followed in the clinical trials to remove the occurrence of bias of study results. Clinical trials professionals strive to provide advanced patient services could enhance the patient’s health outcomes and minimize the treatment related harmful effects.

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