Phases of Clinical Trial.

PREPARED BY-ADITYA SAHU

 Introduction

Clinical Trial:
“Clinical trial is a systematic investigation in human
subjects for evaluating the safety and efficacy of new
drug.”
Clinical trial are a set of tests in medical research and
drug development that generate safety and efficacy
data for health intervention in the human beings.
 Introduction

Clinical trial are conducted only when.

 Satisfactory information has been gathered on the

quality of the nonclinical safety.
 Health authority/ethic committee approval is
granted in the country where approval of the drug is
sought
 Clinical trial is the mainstay for bringing out new
drugs to the market.
 Phase 0 study /microdosing

 Study of new drug in microdoses to derive PK

information in human before undertaking phase 1
studies is called phase 0.
 Micro dose less then 1/100 of the does of a test
substance calculated produced pharmacological
effect with a max does < 100 micrograms.
 Phase 0 clinical trial are not mandatory. They are
case to case based.
Objective:
 To obtain preliminary pharmacokinetic data.
 To assess whether the mechanism of action defined
in pre clinical studies is achieved or not.
 Phase 1

 First stage of testing in human subject

 Designed to assess the safety tolerability, PK &PD of
drug
 Take 20 to 25 healthy volunteers
 Patients : anticancer drugs, AIDS therapy
 Duration 6 to 12th month
 No blinding/open labeled.
 The aim of a phase 1 trail is to determine the
maximum tolerated does(MTD) of the new
treatment.
 The MTD is found by escalating the treatment does
until the does – limiting toxicity (DLT) is reached.
 Kind of phase 1
 SAD: single ascending does studies
 MAD: multiple ascending does studies
 Food effect : investigates difference in absorption
cased by food .
 Phase 2

 Therapeutic exploratory trail.

 Take 20-300 subjects.
 To confirm effectiveness, monitor side effects, and
further evaluate safety.
 First in patients expected (who have the disease that
the drug is expected to treat).
 Duration 6 month to several years.
Objective
 Efficacy in patients (primary objective).
 safety issues (secondary objective).
 Phase 3

 Therapeutic confirmatory trails.

 Large scale, multicenter, randomized, controlled
trails.
 Target population: several 100s to 3000 patients.
 Take a long times: up to 5 years.
 To establish efficacy of the drug against existing
therapy in large number of patients, method of
usage, and to collect safety data etc.
 Phase 4

 Done after drug has been marketed.

 Post marketing surveillance(PMS).
 No fixed duration/ patient population.
 Studies continue to collect data about effects in
various population and side effects from long term
use.
 These are primarily observational or non-
experimental in nature.
 Helps to detect rare ADRs, drugs interaction.