• 9964432222
  • Mail Us
  • Appointment
  • Locate Us
  • Chat Now
  • Courses
  • Login
  • Register
Manifest IAS
JournalsOfIndia
Advertisement
  • Home
  • Economy
  • Foreign Affairs
  • Science & Tech
  • Environment
  • Law & Policy
  • History
No Result
View All Result
  • Home
  • Economy
  • Foreign Affairs
  • Science & Tech
  • Environment
  • Law & Policy
  • History
No Result
View All Result
  • 9964432222
  • Mail Us
  • Appointment
  • Locate Us
  • Chat Now
  • Courses
JournalsOfIndia
No Result
View All Result
Home Science & Tech

What are Human clinical trials?

December 12, 2020
in Science & Tech, Law & Policy
Reading Time: 3min read
0
What are Human clinical trials?
0
SHARES
65
VIEWS
Share on TelegramShare on Facebook

In news 

India’s first indigenous mRNA vaccine candidate receives approval to initiate Phase 1 and 2 human clinical trials

A brief note on novel mRNA vaccine

  • The novel mRNA vaccine candidate, HGCO19 has been developed by Gennova, Pune and supported with seed grant under the Ind-CEPI mission of the Department of Biotechnology.
  • The mRNA vaccines do not use the conventional model to produce immune response. 
  • Instead, they carry the molecular instructions to make the protein in the body through a synthetic RNA of the virus. 
  • mRNA-based vaccines are scientifically the ideal choice to address a pandemic because of their rapid developmental timeline. 
  • The mRNA vaccine is considered safe as is non-infectious, non-integrating in nature, and degraded by standard cellular mechanisms.

What are clinical trials?

  • According to WHO, Clinical trials are a type of research that studies new tests and treatments and evaluates their effects on human health outcomes. 
  • People volunteer to take part in clinical trials to test medical interventions including drugs, cells and other biological products, surgical procedures, radiological procedures, devices, behavioural treatments and preventive care.
  • Clinical trials are carefully designed, reviewed and completed, and need to be approved before they can start. People of all ages can take part in clinical trials, including children.

Four phases of clinical trials

There are 4 phases of biomedical clinical trials:

  • Phase I studies usually test new drugs for the first time in a small group of people to evaluate a safe dosage range and identify side effects.
  • Phase II studies test treatments that have been found to be safe in phase I but now need a larger group of human subjects to monitor for any adverse effects.
  • Phase III studies are conducted on larger populations and in different regions and countries, and are often the step right before a new treatment is approved.
  • Phase IV studies take place after country approval and there is a need for further testing in a wide population over a longer timeframe.

Clinical trials in India 

  • Clinical trials in India refers to clinical research in India in which researchers test drugs and other treatments on research participants. 
  • The New Drugs and Clinical Trials Rules, 2019 and section 3.7.1 to 3.7.3 of ICMR guidelines requires that all researchers conducting a clinical trial must publicly document it in the Clinical Trials Registry India

Who regulates Human Clinical trials in India?

  • The Drugs Controller General of India grants approval for clinical trials and is the top level authority that specifically oversees clinical trials
  • The Drugs Controller is a part of the Central Drugs Standard Control Organisation and answers to that organization. 
  • Both of those organizations answer to the Ministry of Health and Family Welfare as the highest level government agency overseeing everything related to medicine and health. 
  • The Indian Council of Medical Research governs the professional and ethical behavior of the doctors and scientists. 
  • The Pharmacovigilance Program of India tracks reports of harm from the use of drugs. 
  • Outside of the central government, each state has its own regional regulatory agencies with some input into governing trials.
Source: PIB & WHO
Tags: PRELIMS

Related Posts

Tejas 1A

Tejas 1A

January 15, 2021
e-Kranti

e-Kranti

January 15, 2021
Deendayal Disabled Rehabilitation Scheme

Deendayal Disabled Rehabilitation Scheme

January 15, 2021
Right of Persons with Disabilities Act, 2016

Right of Persons with Disabilities Act, 2016

January 15, 2021
UN Convention Right of Person with Disability(UNCRPD)

UN Convention Right of Person with Disability(UNCRPD)

January 15, 2021
Swachh Bharat Mission Urban

Swachh Bharat Mission Urban

January 15, 2021
National Innovation Foundation

National Innovation Foundation

January 15, 2021
Vigyan Jyoti and Engage with Science (Vigyan Prasar)

Vigyan Jyoti and Engage with Science (Vigyan Prasar)

January 14, 2021
Medical Model of Disability Vs  Social Model of Disability

Medical Model of Disability Vs Social Model of Disability

January 14, 2021
Antodaya Anna Yojana

Antodaya Anna Yojana

January 14, 2021
Please login to join discussion

Browse by Category

  • Agriculture
  • Disaster Management
  • Economy
  • Environment
  • Ethics
  • Foreign Affairs
  • Geography
  • Governance
  • History
  • Law & Policy
  • Opinion
  • People in News
  • Places in News
  • Science & Tech
  • Security
  • Society

Browse by Tags

BIG PICTURE GS-1 GS-2 GS-3 GS-4 KURUKSHTERA MAINS NEWS PAPER PIB PRELIMS RSTV YOJANA
JournalsOfIndia

Our vision is to orient the readers to grasp the facts objectively and analyse critically. In the rush of reaching first to the readers, the websites miss the balanced opinion, which is the need of the hour. We aim to reach the readers with more crispness, preciseness and relevance. We bring the articles in UPSC way for the civil services aspirants and the Wisest Way for general readers.

Categories

  • Agriculture
  • Disaster Management
  • Economy
  • Environment
  • Ethics
  • Foreign Affairs
  • Geography
  • Governance
  • History
  • Law & Policy
  • Opinion
  • People in News
  • Places in News
  • Science & Tech
  • Security
  • Society

Browse by Tag

BIG PICTURE GS-1 GS-2 GS-3 GS-4 KURUKSHTERA MAINS NEWS PAPER PIB PRELIMS RSTV YOJANA

Newsletter

The most important UPSC news and events of the day.

Get Journals daily newsletter on your inbox.

© 2020 JournalsOfIndia - A free initiative by Manifest Team.

  • Login
  • Sign Up
  • Home
  • Prelims Snippets
  • Mains Articles
  • Economy
  • Society
  • Foreign Affairs
  • Science & Tech
  • Environment
  • Agriculture
  • History
  • Law & Policy
  • Security
  • Course Portal
  • Prelims Test Portal
No Result
View All Result

© 2020 JournalsOfIndia - A free initiative by Manifest Team.

Welcome Back!

Login to your account below

Forgotten Password? Sign Up

Create New Account!

Fill the forms bellow to register

All fields are required. Log In

Retrieve your password

Please enter your username or email address to reset your password.

Log In