REVIEW ON CLINICAL TRIALS
Final Year Graduate Student
Sri Lakshmi Narasimha College of Pharmacy,
Palluru, Chittoor-517132, Andhra Pradesh, India.
Clinical trials are the set of procedures in medical research and drug development that are conducted to allow safety and efficacy data to be collected for place only interventions. These trials can take place only after satisfactory information has been gathered on the quality of the country where the trial is taking place.
Depending on the type of product and the stage of its development, investigators enrol healthy volunteers and patients into small pilot studies, followed by larger scale studies in patients that often compare the new product with the currently prescribed treatment. As positive safety and efficacy data are gathered, the number of patients is typically increased. Clinical trials can vary in size from a single centre in one country to multicenter trials in multiple countries.
REFERENCE ID: PHARMATUTOR-ART-1641
TYPES OF CLINICAL TRIALS:
The U.S. National Institute of Health (NIH) organises trials into 5 different types:
A. Prevention trials
B. Screening trials
C. Diagnostic trials
D. Treatment trials
E. Quality of life trials
A. Prevention trials:
Look for better ways to prevent disease in people who have never had the disease or to prevent a disease from returning.
Test the best way to detect certain diseases or healthy conditions.
Conducted to find better tests or procedures for diagnosing a particular disease or condition.
D. Treatment trials:
Test experimental treatments, new combination of drugs, new approaches to surgery or radiation therapy.
E.Quality of life trials:
Exposure way to improve comfort and the quality of life for individuals with a chronic illness.
- These are 4 phases. The drug development process will normally proceed through all four phase over many years. If the drug successfully passes through phase I, II, III, it will usually be approved by the national regulatory authority for use in the general population. Phase IV are the ‘post-approval’ studies.
- Before pharmaceutical companies start clinical trials on a drug, they conduct extensive pre-clinical studies.
It involves in vitro and in vivo experiments using wide ranging doses of the study drug to obtain preliminary efficacy, toxicity and pharmacokinetic information. Such tests assist pharmaceutical companies to decide whether a drug candidate has scientific merit for further development as an investigational new drug.
PHASE 0: (HUMAN MICRODOSING STUDIES)
First in human trials conducted accordance with the FDA 2006 guidance.
- These trials are designed to speed up the devel;opment of promising drugs by establishing very early on whether the drug or agent behaves in human subjects as was expected from pre-clinical studies.
- Phase 0 trials includes administration of single sub therapeutic doses of the study drug to a small number of subjects (10-15) to gather preliminary data on the agent’s pharmacodynamics and pharmacokinetics.
- A phase 0 study gives no data on safety or efficacy.
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