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Conducting Clinical Trials In India

Tags : Clinical Trials, Clinical Trials India, Conducting Clinical Trials, clinical trial, clinical research, trials
Industry : Pharmaceuticals
Functional Area : R&D
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About "Conducting Clinical Trials In India " topic:

Clinical Trials hold enormous potential for benefiting patients, improving therapeutic regimens and ensuring advancement in medical practice that is evidence based.

Clinical trials are conducted to allow safety and efficacy data to be collected for health interventions (e.g., drugs, devices, therapy protocols). These trials can only take place once satisfactory information has been gathered on the quality of the non-clinical safety, and Health Authority/Ethics Committee approval is granted in the country where the trial is taking place.

http://copdsurvivor.files.wordpress.com/2009/03/clinical_trials.jpg

The availability of a large drug-naive patient population and well-trained medical professionals, coupled with sophisticated technological infrastructure have made India an attractive destination for conducting global clinical trials.

Let us discuss the pros and cons of clinical trials in India......

1 trends , 3 debates , 2 idea contests , 5 question on topic: "Conducting Clinical Trials In India "
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(rate this)
Safe 
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VS
5
 Unsafe
By : Ajay Mantha
Sarangan Aru  |  Argues in support of  "Safe"  |  2 years ago
Its better to argue whether it is beneficial to human race or not,as a medical stundent ,in my opin that conducting trial is very useful to find out the efficacy and potency of newly discovered drugs,so it is useful
Harshad Naik  |  Argues in support of  "Unsafe"  |  3 years ago
In a country like India we still don't have so much infrastructure which can make safe and unharmed clinical trials. In many cases, the trials which are done on human trials are unsafe without any safety backup. The trials in many cases are done...
Shweta Nigam  |  Argues in support of  "Unsafe"  |  4 years ago
These trials are not easy — most vaccine trials, for instance, can't be done in a controlled hospital environment but need to be done in field settings. They need a surveillance infrastructure and a supporting eco-system. We lack in terms of...
 support: 
 
 
Debate: "How safe are our clinical trials?" deleted from your view.
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(rate this)
Volunteers should be paid 
15
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2
 Volunteers should not be paid
By : Ratnakar Naik
vigneshwar reddy  |  Argues in support of  "Volunteers should be paid"  |  3 years ago
ya. volunteers should be paid bcoz inspite of being suffered from the effects of the drug ,they are ready to support the clinical trials for the development of the drug aswell as fulfil his needs. if that drug is benificial ,it is released into...
Charles davison  |  Argues in support of  "Volunteers should not be paid"  |  3 years ago
I would not call them volunteers Person submitting for clinical test should NEVER be paid.Only persons of sound knowledge with ability to understand the need for clinical test,understand and agree for the consequences that arises as a result of...
Bindu Narayan  |  Argues in support of  "Volunteers should be paid"  |  3 years ago
Clinical trial is not a small thing. It has many side effects. A person who undergoes those trials suffers a lot. Volunteers very well know what will their condition during and after the test. Still they are ready to undergo those sufferings and...
 support: 
 
 
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(rate this)
Can everyone participate in clinical trials or Is there any guidelines who should participate?
By : Sarika Singh
LATHA RAVIKUMAR  |  Answered  |  3 years ago
Clinical Trials are very very important to deliver good treatment. There are some disadvantages like side effects to the particular molecule. It even applies to medicine already existing in the market. Also Phase I II finished and in Phase III...
Charles davison  |  Answered  |  3 years ago
I agree with Pranoy kumar that intellicuals have good intentions ,but in country like India having huge population of people BPL/illiterate, it becomes a easy target for financially sounf health firms to target the  illiterate (like kidney...
Bindu Narayan  |  Answered  |  3 years ago
Medical trials should not be taken by everybody. It has many side effects and if the body's immune power is not so strong, its better, the man should avoid it or else it may become harmful for him.
 
 
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(rate this)
1 Conduct audits
By : Harshad Naik
Bindu Narayan  |  Supported idea  "Conduct audits "  |  3 years ago
Taking the help of GCPs to ensure quality and integrity is a very good idea. Not only the companies should keep monitoring the report produced by the investigators to ensure quality and integrity, but after the whole testing is over, the company...
Harshad Naik  |  Added idea  "Conduct audits "  |  3 years ago
To ensure quality and integrity  the companies take the help of  GCPs ( Guidelines for Good Clinical Practice ). Companies select investigators trained in GCPs to conduct auditing . They study the protocol and mainly check for the protection of...
 
 
Ideate: "How should companies ensure the quality and integrity of clinical trial?" deleted from your view.
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Generally people are concerned in protection and safety before doing anything. Are the clinical trials conducted in India safe and what are the steps taken for protection?
By : Rakesh Chakraborty
Harshad Naik  |  Answered  |  3 years ago
The clinical trial that conduct researches must be approved and monitored by an Institutional Review Board (IRB) to make sure the risks are as low as possible and are worth any potential benefits. After going through the study plan they ensure...
 
 
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Clinical trials are expected to have huge growth in India. How the clinical trials are conducted and how many phases does it have?
By : Sanjay Saha
Charles davison  |  Answered  |  3 years ago
Can we call clinical trial phases as first phase of guniea Humans ,coming after lab mice and guniea pigs?  
Bindu Narayan  |  Answered  |  3 years ago
In the first phase, the product is tested on a few people to check its effectiveness, safety , tolerability, pharmacokinetics, and pharmacodynamics of a drug. In the second phase, it is tested on comparatively a bit more number of people and is...
 
 
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(rate this)
1 Enforce ethics guidelines
2 strict rules pertaining to guidelines
By : Bindu Narayan
MUKESH JOSHI MBA(HCS)  |  Supported idea  "Enforce ethics guidelines "  |  3 years ago
Dear you are talking for something which is impossible at least in India 
Sharon Thomson  |  Added idea  "strict rules pertaining to guidelines"  |  3 years ago
stringent auditing + monitoring as well as inspection by DCGI +Regulatory bodies
 
 
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Hi All,  One of my friends has herbal composition ready to be launched in Indian market? Is it required for him to perform clinical trial for the herbal composition, reply immediately? Best, Samayita...
By : samayita choudhuri
tom watson  |  Answered  |  3 months ago
yeah definetly harbal medicines are very effective for your body..and we can see a very positive result very soon...if we talk about our body it need rest through massage and spa because ...our body continously works..it need releief coz healthy...
Sanjay Saha  |  Answered  |  3 years ago
Yes there are some guidelines for Herbal medicines. The WHO has published guidelines in order to define basic criteria for evaluating the quality, safety, and efficacy of herbal medicines aimed at assisting national regulatory authorities,...
 
 
Answer: "For Herbal composition do we have to perform clinical trials and send report to DCGI" deleted from your view.
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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. Accordng to FICCI, the size of the global clinical trials market was nearly $10 billion and predicted to have touched by $26 billion by 2007. 'Diagnos...
By : Ajay Ravi
Swati Dutta  |  Commented  |  2 years ago
because....India is a land of Love, Colors, Culture, Language, Religion, Natural Beauty and it welcomes everyone with open hand..
Siddhartha Roy  |  Commented  |  3 years ago
i find India's heterogeneous multiethnic population, the prime reason behind choosing this country...
 
 
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(rate this)
Benefits of research on this subject 
1
VS
0
 the social taboo connected to the term cannabis
By : Chetan Balani
Chetan Balani  |  Argues in support of  "Benefits of research on this subject"  |  2 years ago
Greetings, The Endocannabinoid System (ECS) has been described as an emerging target for pharmacotherapy (Pacher, 2006). The US government patent (Patent 6630507 Issued on October 7, 2003) on the chemicals known as the cannabinoids has described...
 support: 
 
 
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