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Ensuring safety of clinical research participants is the main focus for any clinical studies. Any clinical study goes through different level of approval before it actually starts at any clinical site and even after it has started there are many guidelines which protects for subject safety. 

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Before the initiation of trial

After initiation of trial

Adverse event: 

Any untoward medical occurrence in the study participant, which does not necessarily have a causal relationship with the trial product, is known as adverse event. 1
Even after the completion of study within a certain amount of time as specified in protocol if any untoward occurrence happens, that is also considered as AE. 2
It also includes clinically significant abnormal laboratory findings. 2

Adverse reaction: 

Any noxious or untoward response to the trial product no matter the dose administered in adverse reaction, also known as adverse drug reaction.1
The causality assessments for AR are done by investigator and sponsor both. 1

Any adverse event becomes serious adverse event when at any dose any one more of the following criterion is met: 5

Death (including deaths due to disease progression). 5
Life threatening. 5
Results in disability or permanent damage. 5
Requires hospitalization or prolongation of existing hospitalization. 5
Leads to congenital anomaly or birth defects. 5
Requires intervention to prevent permanent damage or impairment.5
Important medical events which require medical or surgical help for preventing any of the above 6 criteria. 5


Suspected unexpected serious adverse reaction is the adverse events which are not consistent with applicable product information i.e. these are not listed in Investigator’s brochure or SmPC.6
These events also fulfil criteria of SAEs.6

Organisation looking after patient safety-
CIOMS:  The Council for International Organizations of Medical Sciences (CIOMS) is an International, non-profit, non-government organization. It was constituted in Brussels by UNESCO & WHO in 1949.3
CIOMS’ main area of focus is ethical conduct of research. In 1982, the “International Ethical guidelines for biomedical Research involving human subjects” were published by CIOMS in conjunction with WHO which was later revised and published in 2002.  It is a set of 21 ethical principle regarding experiments of human. The 2002 CIOMS guidelines are designed to support additional national policies of ethics in biomedical research. 3
These guidelines were mostly designed to support scientific validity and ethical justification of any research. 4



Clinical trials:
Clinical trials describes the whole journey of a molecule from its invention to patients. The aim of clinical trials are to find out safety & efficacy of the molecule. There are many steps and stages of approval before the new intervention can reach to the consumer market.  After successful and promising result in animals and human cells (preclinical research), Food & Drug administration (FDA) approval is required for starting further testing and research in humans. 

Clinical trials are done is phases. In the earlier phase, the new intervention is tested to access if the drug is safe and what are the side effects it causes. The later phases are done if the intervention seems to be promising. 

Phases of clinical trials: There are mostly 4 phases of a trial: Phase I, II, III & IV but sometimes phase 0 is also done to find out if the response of the molecule is same as expected from their preclinical studies7 and sometimes to speed up the approval process 8

Phase 0: 

This is 1st in human trial. Also known as ‘micro dosing’ studies. 9
This phase is basically done on small number of subjects (10-15) to gather pharmocokinetic’s data of the study drug on administration of single sub therapeutic dose.  9
There is no benefit for the participants in this phase of any study.

Phase I:

This phase is done in mostly healthy volunteers (20-80) to determine safety and maximum tolerated dose of the study drug. 10
The first few subjects often gets a very low dose and dosage levels are increased based on the acceptable level of side effects. 10
If the study drug is found reasonably safe, than the molecule proceeds for phase II study.

Phase II:

This phase is done in larger number of subjects (100-300) to determines efficacy of the study drug and to further evaluate its safety. 7
These are mostly randomised trials but no placebo is used. 10
Only 1/3rd of the study drug completes both phase I and phase II successfully. 10

Phase III: 

In this phase mostly the study drug is compared with the existing standard of care treatment to determine benefits and range of possible adverse reactions. 10
This phase is the longest phase and involves several hundreds to several thousand subjects. 10
These studies are often randomised, multi centric and multi national studies.
Apart from comparison of the study drug to standard of care treatment, Phase III are done to find out different doses or ways of giving a standard treatment.
Only after successful completion of this phase, a new drug application (NDA) is submitted to the Food and drug administration (FDA) to request approval. 10

Phase IV:

These are done on the drugs which has received marketing approval from FDA, hence also known as post marketing surveillance.10
The idea behind phase IV study is to know more about the side effects and safety of drug including its long term risks and benefits, about its impact on quality of life of subjects, etc. 10
This is also done to determine its cost effectiveness over other newer or traditional therapies. 10


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