Pharmaceutical Regulatory science…. Bpharmacy,final year ,BP804ETUnit – IV: (8 Hours)

Clinical Trials

Developing clinical trial protocols, Institutional Review Board/Independent Ethics committee

– formation and working procedures, Informed consent process and procedures, GCP

obligations of Investigators, sponsors and Monitors, Managing and Monitoring clinical trials,

Pharmacovigilance – safety monitoring in clinical trials.

5.1 INTRODUCTION

New tests and therapies are not directly used for the public once they’re made; rather

they need to be studied clinically. Clinical research is a branch of healthcare science that

establishes the safety and effectiveness of medications, devices, diagnostic products, and

treatment regimens intended for human use. Clinical research studies on human participants

are designed to answer specific questions about biomedical or behavioral interventions such

as novel vaccines, drugs, dietary choices, dietary supplements, and medical devices and

known interventions that warrant further study and comparison. This research is conducted

for prevention, treatment, diagnosis, or for relieving symptoms of a disease. Clinical research

is different from linical practice that in clinical practice established treatments are used,

while in clinical research evidence is collected to establish a treatment.

Clinical trials are experiments or observations done in clinical research. These trials are a

type of research that studies a test or treatment given to people to show how safe and

helpful tests and treatments are. When found to be safe and helpful, they may become

tomorrow’s standard of care. Clinical trials can be used to study, determine, and establish

many things that include the following:

1. New drugs are not yet approved by the regulatory agency (e.g. U.S. FDA in USA,

CDSCO in India).

2. New uses of drugs that are already approved by the regula

tory agenyso

(5.1)