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How safe are our clinical trials?

Created by : Ajay Mantha, Asst. Manager/Manager -(NonTechnical), Genpact  | 09 20 2008 10:16:44 +0000
Industry : ITES / BPO / Customer ServiceFunctional Area : Innovation(Strategy & Execution)
Keywords : INDIA Safe Clinical Trials Trials Clinical
Activity:  982 views;  last activity : 06 18 2011 16:09:03 +0000
 
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Hi Guys,

its not an argument but sharing the known things. i have been Managing with international trials n generics data from past few years.

It was really unsafe few years back, but now in India every trial needs to be registered.  anytime audit can happen. Even for a generic and indian trials also. now the data is better than previous trials and frequently audits happenning. awareness n also patient informed consent form need to be in local language to understand or guardian.

now not 100% but safe.

 
By Mundra H, Manager Clinical Data Management, Ranbaxy Laboratories Ltd  08 19 2009 19:38:33 +0000
 
Top Argument
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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 infrastructure and development so how can we say that our trials are safe.
By Shweta Nigam, Asst. Manager/Manager -(NonTechnical), IBM-Daksh  09 20 2008 10:18:51 +0000
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I am fully agree to you sir...
By rahul arora, M.Pharma student, MDU  | 06 18 2011 16:09:03 +0000
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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
By Sarangan Aru, MBBS student, thanjavur medical college  | 01 01 2011 23:11:50 +0000
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ya, conducting clinical trials are safe becuse it provides the details of efficiency n safety data  as wel as adverse effects of the drug. by knowing them it wil benifited to deliver the product into the market,giving assurance based on the safety result n v can minimise the side effects.firstly after knowing the lead compoud,they should be screened .it should be done in animals. so after knowing the safety of compound only, clinical trials are done in humans. so it wont be a problem for humans.
By vigneshwar reddy, B.Sc student, bio technology  | 10 26 2009 05:34:59 +0000
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hi to all....

i also stronlgly bieleve that clinical trials must go on and there is no harm to do so as if they are tested on animals first and not on the humans and now when i say that on "animals first again the question arises that y not on humans and y on animals they r also the creatures of god "...so with respect to this question i can justify that until and unless the clinical trails not perofm we cant or anyobody cant come to any conclusion about the new drug and the second thing oabout the safe and unsaf so its  a safe procedure to do so as all the scientists take a year r more than that to study a new molecule of a new drug and in that years they tottallly study thye whle biological and chemical properties of that moleclue after that they all go for clinical trails .......
By sanchit gupta, B.Tech/B.E. student, meerut institute of engineering and technology,meerut  | 10 18 2009 16:33:59 +0000
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without clinical trails we cannot &should not put into market (large group of people in the society)
References :
Cohort study - Wikipedia, the free encyclopediaA cohort study or panel study is a form of longitudinal study used in medicine, social science and ecology. It is one type of study design and should be ...en.wikipedia.org

By dr.k.krishna mohana reddy, Associate Professor, gpr dental collage  | 10 14 2009 04:13:27 +0000
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clinical trials are conducted over various phases, phase 1 to 4. Drugs are tested beginging from animals and later into humans trials. Even after the drugs are in to the market they are being monitored. But how effectively these trials are bieng monitored is the key question.  

Since many regulatory agencies have put up stringent rules and regulatios in place, i personally belive that clinical trials are heading in the right direction, safegaurding the human rights.
By R Sai Sreedhar, Drug safety, Pharmaceutical Inds  | 10 13 2009 14:43:23 +0000
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There is nothing so called absolutely safe. It depends on the benefits vs risks. In Indian scenario where we have a large population which cannot afford good medical services the clinical research provides such kind of alternative. Also our regulatory agencies are becoming more stringent where the human safety is concern and therefore day by day the scenario of clinical research is improving
By Dr. Seema Goel, Documentation/Medical Writing, Accenture Services Pvt.Ltd  | 09 29 2008 14:34:14 +0000
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A supportive eco-system is developing to ensure safety but since the system is by and large self-regulatory, it will be a while before it is fully secure. The major reason for why we need to do clinical trials, of course, is that India is now developing new molecules on its own — previously, we did just limited trials since we were copying drugs developed abroad. Right now, new molecules have been developed for diabetes, TB, cancer, and so on. So it will take time but what ever is done is safe.
By Ajay Mantha, Asst. Manager/Manager -(NonTechnical), Genpact  | 09 20 2008 10:16:44 +0000
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Supporting swetha's argument.
By Resmi Maxim, GENERAL MANAGER - OPERATIONS, SI PROPERTY (KERALA) PVT.LTD.,  | 11 19 2009 10:00:06 +0000
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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 in India in the absence of proper security. Most vaccine trials are done in a controlled hospital environment in the absence of field settings. They need a surveillance infrastructure and a supporting eco-system. I feel any clinical trial on human volunteers should not be allowed unless it satisfies all international stipulations on ethical committee and periodic verification by international drug safety bodies.No single person should be given authority to launch a human clinical trial for any drug.
By Harshad Naik, Product Development Manager, Care Biomedicals  | 10 26 2009 07:12:47 +0000
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We do lack stringent measures to make clinical trials safe. The clinical trial coducted by Reginal cancer Centre, Trivandrum became a controversy, because of this fact. The cytotoxic drug which was put on human clinical trial there had no safety back up there.The head of the institute was found to be involved in this controversy.I strongly argue against any clinical trial on human volunteers unless it satisfies all international stipulations on ehical committee and periodic verification by international drug safety bodies.No single person should be given authority to launch a human clinical trial for any drug.
By Balachandran Prabhakaran, Medical director, Gulf star Medical centre  | 10 14 2009 04:33:12 +0000
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