Clinical trials in india

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Clinical trials in india

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Clinical trials in india

  1. 1. CHENNAI 3rd 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 COIMBATORE BB1, Park Avenue, # 48, Race Course Road, Coimbatore - 641018. Tel: +91 - 422 – 6552921 EMAIL info@altacit.com WEBSITE www.altacit.com CLINICAL TRIALS IN INDIA KRISHNAVENI.S HEAD -RESEARCH
  2. 2. CHENNAI 3rd 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 COIMBATORE BB1, Park Avenue, # 48, Race Course Road, Coimbatore - 641018. Tel: +91 - 422 – 6552921 EMAIL info@altacit.com 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.
  3. 3. CHENNAI 3rd 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 COIMBATORE BB1, Park Avenue, # 48, Race Course Road, Coimbatore - 641018. Tel: +91 - 422 – 6552921 EMAIL info@altacit.com 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
  4. 4. CHENNAI 3rd 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 COIMBATORE BB1, Park Avenue, # 48, Race Course Road, Coimbatore - 641018. Tel: +91 - 422 – 6552921 EMAIL info@altacit.com WEBSITE www.altacit.com
  5. 5. CHENNAI 3rd 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 COIMBATORE BB1, Park Avenue, # 48, Race Course Road, Coimbatore - 641018. Tel: +91 - 422 – 6552921 EMAIL info@altacit.com WEBSITE www.altacit.com METhODs IN ClINICal TRIal
  6. 6. CHENNAI 3rd 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 COIMBATORE BB1, Park Avenue, # 48, Race Course Road, Coimbatore - 641018. Tel: +91 - 422 – 6552921 EMAIL info@altacit.com 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
  7. 7. CHENNAI 3rd 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 COIMBATORE BB1, Park Avenue, # 48, Race Course Road, Coimbatore - 641018. Tel: +91 - 422 – 6552921 EMAIL info@altacit.com 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
  8. 8. CHENNAI 3rd 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 COIMBATORE BB1, Park Avenue, # 48, Race Course Road, Coimbatore - 641018. Tel: +91 - 422 – 6552921 EMAIL info@altacit.com 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.
  9. 9. CHENNAI 3rd 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 COIMBATORE BB1, Park Avenue, # 48, Race Course Road, Coimbatore - 641018. Tel: +91 - 422 – 6552921 EMAIL info@altacit.com 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.
  10. 10. CHENNAI 3rd 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 COIMBATORE BB1, Park Avenue, # 48, Race Course Road, Coimbatore - 641018. Tel: +91 - 422 – 6552921 EMAIL info@altacit.com 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
  11. 11. CHENNAI 3rd 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 COIMBATORE BB1, Park Avenue, # 48, Race Course Road, Coimbatore - 641018. Tel: +91 - 422 – 6552921 EMAIL info@altacit.com 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.
  12. 12. CHENNAI 3rd 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 COIMBATORE BB1, Park Avenue, # 48, Race Course Road, Coimbatore - 641018. Tel: +91 - 422 – 6552921 EMAIL info@altacit.com 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.
  13. 13. CHENNAI 3rd 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 COIMBATORE BB1, Park Avenue, # 48, Race Course Road, Coimbatore - 641018. Tel: +91 - 422 – 6552921 EMAIL info@altacit.com 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. ” 
  14. 14. CHENNAI 3rd 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 COIMBATORE BB1, Park Avenue, # 48, Race Course Road, Coimbatore - 641018. Tel: +91 - 422 – 6552921 EMAIL info@altacit.com 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
  15. 15. CHENNAI 3rd 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 COIMBATORE BB1, Park Avenue, # 48, Race Course Road, Coimbatore - 641018. Tel: +91 - 422 – 6552921 EMAIL info@altacit.com 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.
  16. 16. CHENNAI 3rd 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 COIMBATORE BB1, Park Avenue, # 48, Race Course Road, Coimbatore - 641018. Tel: +91 - 422 – 6552921 EMAIL info@altacit.com 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 20th 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
  17. 17. CHENNAI 3rd 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 COIMBATORE BB1, Park Avenue, # 48, Race Course Road, Coimbatore - 641018. Tel: +91 - 422 – 6552921 EMAIL info@altacit.com 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."
  18. 18. CHENNAI 3rd 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 COIMBATORE BB1, Park Avenue, # 48, Race Course Road, Coimbatore - 641018. Tel: +91 - 422 – 6552921 EMAIL info@altacit.com 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
  19. 19. CHENNAI 3rd 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 COIMBATORE BB1, Park Avenue, # 48, Race Course Road, Coimbatore - 641018. Tel: +91 - 422 – 6552921 EMAIL info@altacit.com WEBSITE www.altacit.com COnClUsiOn

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