Randomized control trial

Definition

 the most commonly used experimental study in health science research

Design

Target population ------sample population-----randomisation----

experment group 1--- group 2

-intervention---- intervention

over a time------ over a time

effect or impact effect or impact

Clinical trials

Types

 Prophylactic trial- immunization, contraception

 Therapeutic trial- drug treatment, surgical procedure
 Safety trial- side effects of OCP,Injectables
 Risk factor trial- etiology of disease, smoking cessation

Clinical trial:

o Drugs for prevention, treatment, palliation

o Clinical device
o Surgical procedure
o Medical counseling
o Diet,exercise,lifestyle habits
o Hospital services
o Risk factor
o Communication approach
o Categories of health personnel
o Treatment regimen

Phases

Four phases of clinical trial

I phase:

 First phase in human

 Pharmacological and toxicological studies in Experimental animals
 Volunteers receive a fraction of anticipated dose and monitored for body functions
 Require close supervision
 Need high technology in biochemistry, Pharmacology, endocrinology etc
 Short duration
II phase
 Volunteers
 Assess the effectiveness of the drug or device
 Dose response relationship
 Effectiveness of the drug assessed
III phase
 Classic phase
 Consent
 Inclusion and exclusion criteria
 Assess effectiveness, safety
 Hospital inpatients

IV phase

Factors affecting clinical trial