clinical trials in india
TRANSCRIPT
CHENNAI3rd Floor, ‘Creative Enclave’,
148-150, Luz Church Road,Mylapore,
Chennai - 600 004.Tel: +91 - 44 - 2498 4821
BANGALORE Suite 920, Level 9,
Raheja Towers,26-27, M G Road,
Bangalore - 560 001.Tel: +91 - 80 - 6546 2400
COIMBATOREBB1, Park Avenue,
# 48, Race Course Road,Coimbatore - 641018.
Tel: +91 - 422 – 6552921
WEBSITE
www.altacit.com
CLINICAL TRIALS IN INDIA
KRISHNAVENI.SHEAD -RESEARCH
CHENNAI3rd Floor, ‘Creative Enclave’,
148-150, Luz Church Road,Mylapore,
Chennai - 600 004.Tel: +91 - 44 - 2498 4821
BANGALORE Suite 920, Level 9,
Raheja Towers,26-27, M G Road,
Bangalore - 560 001.Tel: +91 - 80 - 6546 2400
COIMBATOREBB1, Park Avenue,
# 48, Race Course Road,Coimbatore - 641018.
Tel: +91 - 422 – 6552921
WEBSITE
www.altacit.com
INTRODUCTION
Clinical Trail an ancient concept is a medical research study conducted to find answers to health questions and is often conducted to evaluate new medications, a combination of medications, or new ways to use current treatments. They are also conducted to evaluate new tests, equipment, and procedures for diagnosing and detecting health conditions and to find vaccines to prevent illnesses. Before an experimental treatment can be tested in a clinical trial, it must have shown benefit in laboratory testing, animal research studies, or research in a small group of humans. Clinical trials are required to follow the same ethical and legal guidelines as standard medical practice to protect the safety of participants.
CHENNAI3rd Floor, ‘Creative Enclave’,
148-150, Luz Church Road,Mylapore,
Chennai - 600 004.Tel: +91 - 44 - 2498 4821
BANGALORE Suite 920, Level 9,
Raheja Towers,26-27, M G Road,
Bangalore - 560 001.Tel: +91 - 80 - 6546 2400
COIMBATOREBB1, Park Avenue,
# 48, Race Course Road,Coimbatore - 641018.
Tel: +91 - 422 – 6552921
WEBSITE
www.altacit.com
EvOlUTION
Clinical Trail has traversed a long and fascinating journey . Its evolution from the Bibilical times to the 21st century has reached a juncture wherein governments found it imperative to enact statutes and formulate registries to regulate the same . The first reference to a clinical trial can be found in the Bible . King, ‘Nebuchadnezzar’ in BABYLON ordered his people to eat only meat and drink wine, but there were also vegetarians, who consumed vegetables. After 10 days, the king found that those who followed the diet of pulses and water were fitter than the others
CHENNAI3rd Floor, ‘Creative Enclave’,
148-150, Luz Church Road,Mylapore,
Chennai - 600 004.Tel: +91 - 44 - 2498 4821
BANGALORE Suite 920, Level 9,
Raheja Towers,26-27, M G Road,
Bangalore - 560 001.Tel: +91 - 80 - 6546 2400
COIMBATOREBB1, Park Avenue,
# 48, Race Course Road,Coimbatore - 641018.
Tel: +91 - 422 – 6552921
WEBSITE
www.altacit.com
CHENNAI3rd Floor, ‘Creative Enclave’,
148-150, Luz Church Road,Mylapore,
Chennai - 600 004.Tel: +91 - 44 - 2498 4821
BANGALORE Suite 920, Level 9,
Raheja Towers,26-27, M G Road,
Bangalore - 560 001.Tel: +91 - 80 - 6546 2400
COIMBATOREBB1, Park Avenue,
# 48, Race Course Road,Coimbatore - 641018.
Tel: +91 - 422 – 6552921
WEBSITE
www.altacit.com
METhODs IN ClINICal TRIal
CHENNAI3rd Floor, ‘Creative Enclave’,
148-150, Luz Church Road,Mylapore,
Chennai - 600 004.Tel: +91 - 44 - 2498 4821
BANGALORE Suite 920, Level 9,
Raheja Towers,26-27, M G Road,
Bangalore - 560 001.Tel: +91 - 80 - 6546 2400
COIMBATOREBB1, Park Avenue,
# 48, Race Course Road,Coimbatore - 641018.
Tel: +91 - 422 – 6552921
WEBSITE
www.altacit.com
Why conduct a clinical trial
Some of the questions answered by doing a clinical trial are:
How helpful the treatment is?
How does the experimental drug or new type of treatment work?
If it works better than already existing treatment options?
What are the side effects that occur as a result of the new treatment/ drug?
How serious the side effects are when compared to standard treatment options?
Do the benefits outweigh the side effects?
Which groups of people are most likely to benefit from the new drug / treatment
CHENNAI3rd Floor, ‘Creative Enclave’,
148-150, Luz Church Road,Mylapore,
Chennai - 600 004.Tel: +91 - 44 - 2498 4821
BANGALORE Suite 920, Level 9,
Raheja Towers,26-27, M G Road,
Bangalore - 560 001.Tel: +91 - 80 - 6546 2400
COIMBATOREBB1, Park Avenue,
# 48, Race Course Road,Coimbatore - 641018.
Tel: +91 - 422 – 6552921
WEBSITE
www.altacit.com
clinical trials – a part of drug development and
approval process
The drug development process is an extremely complex one. It goes through various processes before it could come out into the market. The various steps include:
Pre - clinical research , here the new chemicals are discovered in laboratories and tested in animals for safety and biological activity.
All new drugs for marketing or sale have to be approved by the Licensing Authority of India ( DCI ). For granting approval to manufacture the new drug and its formulation a form with a fee has to be submitted to the Licensing Authority
•
CHENNAI3rd Floor, ‘Creative Enclave’,
148-150, Luz Church Road,Mylapore,
Chennai - 600 004.Tel: +91 - 44 - 2498 4821
BANGALORE Suite 920, Level 9,
Raheja Towers,26-27, M G Road,
Bangalore - 560 001.Tel: +91 - 80 - 6546 2400
COIMBATOREBB1, Park Avenue,
# 48, Race Course Road,Coimbatore - 641018.
Tel: +91 - 422 – 6552921
WEBSITE
www.altacit.com
stages in clinical trial
After The Licensing Authority gives its initial approval for manufacturing of the drug
another form has to be submitted for approval to conduct the various phases of the clinical trial.
On completion of the 3 phases of the trial , the manufacturers should submit information pertaining to the results of the clinical trials carried out in the country in accordance with the countries specified guidelines.
The Licensing Authority issues its approval after it is satisfied that the drug if approved to be manufactured shall be effective and safe for use in the country.
CHENNAI3rd Floor, ‘Creative Enclave’,
148-150, Luz Church Road,Mylapore,
Chennai - 600 004.Tel: +91 - 44 - 2498 4821
BANGALORE Suite 920, Level 9,
Raheja Towers,26-27, M G Road,
Bangalore - 560 001.Tel: +91 - 80 - 6546 2400
COIMBATOREBB1, Park Avenue,
# 48, Race Course Road,Coimbatore - 641018.
Tel: +91 - 422 – 6552921
WEBSITE
www.altacit.com
participation in a clinical trial
The goal of clinical trials is to determine if a new test
or treatment works and is safe. Clinical trials can also
look at other aspects of care, such as improving the
quality of life for people with chronic illnesses.
People participate in clinical trials for a variety of
reasons. Healthy volunteers say they participate to
help others and to contribute to moving science
forward. Participants with an illness or disease also
participate to help others, but also to possibly receive
the newest treatment and to have the additional care
and attention from the clinical trial staff.
Clinical trials offer hope for many people and an
opportunity to help researchers find better treatments
for others in the future.
CHENNAI3rd Floor, ‘Creative Enclave’,
148-150, Luz Church Road,Mylapore,
Chennai - 600 004.Tel: +91 - 44 - 2498 4821
BANGALORE Suite 920, Level 9,
Raheja Towers,26-27, M G Road,
Bangalore - 560 001.Tel: +91 - 80 - 6546 2400
COIMBATOREBB1, Park Avenue,
# 48, Race Course Road,Coimbatore - 641018.
Tel: +91 - 422 – 6552921
WEBSITE
www.altacit.com
precautions to Be taKen
Before participating, you must be provided with an "informed consent" document explaining the risks and potential benefits of the trial. Be sure to read over this information carefully. It is important to fully understand the purpose of the trial and what to expect. Whether the treatment will interact with any of your current medications or affect any other medical conditions you may have. You should be informed about what tests or procedures, such as biopsies or blood draws, will be performed, and you should consider your comfort level with what will be done. Also, think about whether you are prepared for any anticipated side effects, pain, or discomfort that may be involved.Another consideration is how the trial will affect your daily life. Think about how long the study lasts, if it will fit in your work schedule and personal life, and if you can commit to it. Will the hours at the clinic require that you take time off work? How many visits will be involved?.
If you do decide to participate, you will be required to sign an informed consent document, and a copy will be given to you. The document will include the contact information for someone you can call should any questions or concerns arise during the trial
CHENNAI3rd Floor, ‘Creative Enclave’,
148-150, Luz Church Road,Mylapore,
Chennai - 600 004.Tel: +91 - 44 - 2498 4821
BANGALORE Suite 920, Level 9,
Raheja Towers,26-27, M G Road,
Bangalore - 560 001.Tel: +91 - 80 - 6546 2400
COIMBATOREBB1, Park Avenue,
# 48, Race Course Road,Coimbatore - 641018.
Tel: +91 - 422 – 6552921
WEBSITE
www.altacit.com
INDIA ON THE CLINICAL TRIAL MAP
• A vast, unwieldy population, a plethora of diseases, and rampant poverty: this was the picture India presented to the outside world till a while ago.
• But these days the fact that India has the largest pool of patients suffering from cancer, diabetes and other maladies is leading the country to an altogether different destination: the global hub of outsourcing of clinical trials.
• Almost all the top names in the pharmaceutical world have zeroed-in on India, setting up clinical trail facilities in major cities, especially Hydearbad and Ahmedabad.
CHENNAI3rd Floor, ‘Creative Enclave’,
148-150, Luz Church Road,Mylapore,
Chennai - 600 004.Tel: +91 - 44 - 2498 4821
BANGALORE Suite 920, Level 9,
Raheja Towers,26-27, M G Road,
Bangalore - 560 001.Tel: +91 - 80 - 6546 2400
COIMBATOREBB1, Park Avenue,
# 48, Race Course Road,Coimbatore - 641018.
Tel: +91 - 422 – 6552921
WEBSITE
www.altacit.com
DECIDING FACTORS FOR INDIA
• Pharma giants are also magnetized by India due to the fact that the country offers nearly 700,000 speciality hospital beds, 221 medical colleges and skilled English-speaking medical personnel.
• The Rabo study, however, pinpoints that the biggest advantage is the low cost.
• For instance, trials for a standard drug in the United States can cost about $150 million. A similar drug could be tested in India at a 60 per cent
reduction of that whopping cost.• So today all big global pharma names
like Novo Nordisk, Aventis, Novartis, GlaxoSmithKline, Eli Lilly and Pfizer have begun clinical drug trials across
various Indian cities.
CHENNAI3rd Floor, ‘Creative Enclave’,
148-150, Luz Church Road,Mylapore,
Chennai - 600 004.Tel: +91 - 44 - 2498 4821
BANGALORE Suite 920, Level 9,
Raheja Towers,26-27, M G Road,
Bangalore - 560 001.Tel: +91 - 80 - 6546 2400
COIMBATOREBB1, Park Avenue,
# 48, Race Course Road,Coimbatore - 641018.
Tel: +91 - 422 – 6552921
WEBSITE
www.altacit.com
INDIAN SCENARIO
From 2008 and 2011, around 2,000 patients died during trials, but no action has been taken against any pharma company or the Ethics Committee that oversees clinical trials. Pharmaceutical companies claimed that other deaths occurred due to other reasons, such as patients being terminally ill or suffering side-effects from an unrelated cause.
The government, on its part, has proposed a Committee of Experts, which would recommend the amount of compensation to the DCGI in case of injury or death during the trial. And guidelines for registration of the Ethics Committee would also be prescribed. The Informed Consent Form would include the socio-economic background of the subject and his/her nominee's address. ”
CHENNAI3rd Floor, ‘Creative Enclave’,
148-150, Luz Church Road,Mylapore,
Chennai - 600 004.Tel: +91 - 44 - 2498 4821
BANGALORE Suite 920, Level 9,
Raheja Towers,26-27, M G Road,
Bangalore - 560 001.Tel: +91 - 80 - 6546 2400
COIMBATOREBB1, Park Avenue,
# 48, Race Course Road,Coimbatore - 641018.
Tel: +91 - 422 – 6552921
WEBSITE
www.altacit.com
ROLE OF INDIAN JUDICIARY
• Drug trials in India Almost 2,000 trials in past seven years. Tests include drugs made by well-known companies such as Biogen Idec, Astra Zeneca and Glaxo Smith Kline.
• 288 deaths in 2008• 637 deaths in 2009• 668 deaths in 2010• 438 deaths in 2011
CHENNAI3rd Floor, ‘Creative Enclave’,
148-150, Luz Church Road,Mylapore,
Chennai - 600 004.Tel: +91 - 44 - 2498 4821
BANGALORE Suite 920, Level 9,
Raheja Towers,26-27, M G Road,
Bangalore - 560 001.Tel: +91 - 80 - 6546 2400
COIMBATOREBB1, Park Avenue,
# 48, Race Course Road,Coimbatore - 641018.
Tel: +91 - 422 – 6552921
WEBSITE
www.altacit.com
CLINICAL RESERCH IN INDIA COMES TO A STAND STILL
India is actually losing its hold from the trials. That was the time when it was expected that there will be a bang in clinical research industry in India but recession, regulatory issues, lack of laws, concerns on sector experts for the decline.
• DCGI, usually take 12 to 16 weeks to give approval for the trials when the same require 6 to 8 weeks in US. Countries like China, Korea and Singapore are snatching the trials as they have government certified and trained trial sites that India is lacking.
CHENNAI3rd Floor, ‘Creative Enclave’,
148-150, Luz Church Road,Mylapore,
Chennai - 600 004.Tel: +91 - 44 - 2498 4821
BANGALORE Suite 920, Level 9,
Raheja Towers,26-27, M G Road,
Bangalore - 560 001.Tel: +91 - 80 - 6546 2400
COIMBATOREBB1, Park Avenue,
# 48, Race Course Road,Coimbatore - 641018.
Tel: +91 - 422 – 6552921
WEBSITE
www.altacit.com
The CliniCal Trials regisTry- india
The Clinical Trials Registry- India (CTRI), hosted at the ICMR's National Institute of Medical Statistics (http://nims-icmr.nic.in), is a free and online public record system for registration of clinical trials being conducted in India that was launched on 20 th July 2007 (www.ctri.nic.in). Initiated as a voluntary measure, since 15th June 2009, trial registration in the CTRI has been made mandatory by the Drugs Controller General (India) (DCGI) (www.cdsco.nic.in). Moreover, Editors of Biomedical Journals of 11 major journals of India declared that only registered trials would be considered for publicatio
CHENNAI3rd Floor, ‘Creative Enclave’,
148-150, Luz Church Road,Mylapore,
Chennai - 600 004.Tel: +91 - 44 - 2498 4821
BANGALORE Suite 920, Level 9,
Raheja Towers,26-27, M G Road,
Bangalore - 560 001.Tel: +91 - 80 - 6546 2400
COIMBATOREBB1, Park Avenue,
# 48, Race Course Road,Coimbatore - 641018.
Tel: +91 - 422 – 6552921
WEBSITE
www.altacit.com
risKs in CliniCal Trial
Eight healthy men volunteered to take part in this drug trial. for an experimental drug to treat chronic inflammatory conditions and leukaemia are currently critically ill in Northwick Park hospital, UK. Two of them were given a placebo (dummy drug) while the other six were given the experimental drug - TGN 1412. All six men who were given TGN 1412 are now ill, two of whom are in a critical condition. The other four became seriously ill, but are now said to be making a recovery The neck of one of the men has swollen to three times its normal size. A girlfriend of one of the drug trial volunteers said her boyfriend looked like ?Elephant Man' (BBC). Apparently, his head became wider than his waist.
"He lost all his toes and the tops of some of his fingers. He cannot walk unaided and because the skin won't heal properly on his left foot he still cannot have prosthetics fitted."
CHENNAI3rd Floor, ‘Creative Enclave’,
148-150, Luz Church Road,Mylapore,
Chennai - 600 004.Tel: +91 - 44 - 2498 4821
BANGALORE Suite 920, Level 9,
Raheja Towers,26-27, M G Road,
Bangalore - 560 001.Tel: +91 - 80 - 6546 2400
COIMBATOREBB1, Park Avenue,
# 48, Race Course Road,Coimbatore - 641018.
Tel: +91 - 422 – 6552921
WEBSITE
www.altacit.com
inTernaTiOnal CliniCal Trials day
Each year, the International Clinical Trials'
Day is celebrated around the world on or near
the 20th of May in order to celebrate the day that
James Lind started his famous trial on the 20th of
May 1747 (*www.jameslindlibrary.org).
The challenges of clinical research are not
restricted to a single country, thus transnational
communication on clinical trials requires initiation
and co-ordination by a transnational organisation,
with the objective to facilitate better clinical
research, relevant to the needs of patients
everywhere.
.
The objective is to make the International Clinical Trials' Day a focal point for international communication events, meetings, debates, and celebrations of clinical research
CHENNAI3rd Floor, ‘Creative Enclave’,
148-150, Luz Church Road,Mylapore,
Chennai - 600 004.Tel: +91 - 44 - 2498 4821
BANGALORE Suite 920, Level 9,
Raheja Towers,26-27, M G Road,
Bangalore - 560 001.Tel: +91 - 80 - 6546 2400
COIMBATOREBB1, Park Avenue,
# 48, Race Course Road,Coimbatore - 641018.
Tel: +91 - 422 – 6552921
WEBSITE
www.altacit.com
COnClUsiOn