Overview

Question 1

Clinical Trials definition

Answer 1

Type of research that studies new tests & treatments & evaluates their effects on human health outcomes

Question 2

Phases of Clinical Trials

Answer 2

There are 4 phases of biomedical clinical trials

Phase 1: Pharmacology
Phase 2: Exploratory
Phase 3: Confirmatory
Phase 4: Post Marketing

Question 3

Preclinical Trials

Answer 3

Testing done on Animal subjects or testing computer models & human cells grown in lab

Helps identify efficacy, possible side effects

Question 4

Phase 0

Answer 4

Human Micro dosing study
Single sub therapeutic dose
Small no of subjects ( 10 to 15)

Provides Preliminary data on pharmacokinetics and dynamics

Question 5

Phase 1

Answer 5

20 to 100 volunteers (healthy or diseased)
Length: several months

Purpose: Determine safety and dosage

Safety (phramacovigilance)
Safety dosage range
Identify side effects
Tolerability
Pharmacokinetics
Pharmacodynamics
Route of Administration

Question 6

Type of Phase 1 study

Answer 6

SAD ( single ascending dose)
MAD (multiple ascending dose)
Food effect

Question 7

Single Ascending dose ( SAD)

Answer 7

Small group of subjects given single dose of drug and observed for a period

If data is in line with predicted safe values , dose is increased in a new group pf subjects

Dose escalation continued until MTD is reached

MTD : max tolerated dose

Question 8

MAD

Answer 8

A group of subjects recieve multiple low doses of drug & observed

Sample of blood & other body fluids are collected at various time points & analyzed.

Gives better understanding of kinetics & dynamics of the drugs

Question 9

Food effect studies

Answer 9

To know potential impact of food intake on absorption of drug

Run as a crossover study
Volunteers given two identical doses one after fasting and one after meal

Question 10

Phase 2 trials

Answer 10

Larger group ( several hundred people)

Several months to 2 yrs

To assess efficacy and side effects

Question 11

Phase II A

Pilot trials

Answer 11

Specifically Designed to assess dosing requirements

Question 12

Phase II B

Pivotal Trials

Answer 12

Specifically designed to study efficacy (how well the drugs work)

Question 13

Phase III

Answer 13

Randomized
Controlled and
Multicentrer

300 to 3000 volunteer

1 to 4 yrs

Efficacy and monitoring of Adverse reaction

Question 14

Phase III A

Answer 14

Studies for approval of drug from appropriate regulatory agencies.
Studies are enclosed to regulatory authorities for review and approvla

Question 15

Phase III B

Answer 15

Between submission and approval of Phase IIIA studies
Phase III B studies are conducted
To obtain safety data or support publication marketing claims or to prepare launch for the drug

Question 16

Phase IV

Answer 16

Post marketing surveillance
PMS

Monitoring safety after the drug is released in market (after phase IIIB approval)

Several thousand patients
Safety and efficacy
Less than 4 yrs

Question 17

Post Marketing surveillance tools

Answer 17

Electronic health records
Patient registries
Record linkage between health database

Question 18

IND application

Answer 18

Animal pharmacology & toxicology studies (preclinical Trials)
Chemistry and manufacturing information whether the drug is stable and can be manufactured with high quality.

Investigators brochures.