28/12/15

HEALTH  RESEARCH  FUNDAMENTALS    

NIeCer  101                                                                                            
Na9onal  Ins9tute  of  Epidemiology  
Chennai  
nie.gov.in  

Scenario  of  clinical  trials  in  India  

HEALTH  RESEARCH  FUNDAMENTALS    
NIeCer  101                                                                                            

•  The  clinical  trial  industry  rapidly  expanded  in  the  first  decade  
of  21st  century,  but  has  faced  some  challenges  due  to  
regulatory  reforms  in  2012-­‐13  
•  The  main  challenges  perceived  by  interna9onal  inves9gators  
and  sponsors  include  
Na9onal  Ins9tute  of  Epidemiology  
Chennai  

•  Delayed  approval  
•  Quality  of  ethics  review  
•  Shipment  of  samples:  import  and  export  
•  Overall  deficiency  of  duly  trained  inves9gators  and  centers  
•  Clause  of  compensa9on  even  for  clinical  trial  par9cipants  
•  Recent  requirement  of  audio  visual  recording  of  consent  process  for  
IND  [inves9ga9onal  new  drug]  trials  
nie.gov.in  

1  
 28/12/15  

Scienti0ic,  ethical  and  regulatory  reviews  of  

clinical  trials  are  critical    

HEALTH  RESEARCH  FUNDAMENTALS    

NIeCer  101                                                                                            
Concerns in implementation of Type of Some examples of available
research protocols review agencies/ mechanisms

Is the research question sound? Scientific Institutional Scientific Advisory

review Committee

Na9onal  Ins9tute  of  Epidemiology  

Chennai  
Indian Council of Medical Research

Is the safety and welfare of the Ethical review Institutional Ethics Committee
research participants adequately Central/ National Ethics Committee
protected?

Are the research methods Regulatory Health Ministry Screening Committee

appropriate? review Drug Controller General of India
Genetic Engineering Approval nie.gov.in  
Committee

Addressing  ethical  issues  in  clinical  trials  

HEALTH  RESEARCH  FUNDAMENTALS    
NIeCer  101                                                                                            

•  Is  there  a  mechanism  for  independent  ethical  review?  [Approvals  

from  Ethics  CommiXee  and  in  country  Regulatory  Authority]  
•  Which  mechanisms  exist  to  ensure  protec9on  of  human  subjects  
throughout  trial  par9cipa9on?  
Na9onal  Ins9tute  of  Epidemiology  
Chennai  

•  Is  there  adequate  community  engagement  and  support?  

•  Informed  consent  
•  Standard  of  care  and  post-­‐trial  support  
•  Use  of  placebos  
•  Confiden9ality  
nie.gov.in  

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 28/12/15  

Critical  issues  in  trial  implementation  -­‐1  

HEALTH  RESEARCH  FUNDAMENTALS    

NIeCer  101                                                                                            
•  Informed  consent  procedure  
•  Screening  and  enrollment:  Strict  adherence  to  
inclusion  and  exclusion  criteria  

Na9onal  Ins9tute  of  Epidemiology  

Chennai  
•  Good  clinical  and  laboratory  prac9ce,  quality  
control  and  quality  assurance  
•  Adherence  to  interven9on  and  follow-­‐up  
•  Mul9-­‐centric  trials:  standardiza9on  of  study  
protocols  
nie.gov.in  

Critical  issues  in  trial  implementation  -­‐2  

HEALTH  RESEARCH  FUNDAMENTALS    
NIeCer  101                                                                                            

•  Independent  monitoring  
•  Safety  assessment:  Repor9ng  and  management  
of  adverse  and  serious  adverse  events  [clinical,  
Na9onal  Ins9tute  of  Epidemiology  
Chennai  

laboratory  and  social/  familial]  

•  Reimbursements,  compensa9on  and  grievance  
redressal  
•  Trial  stoppage  rules  
•  Documenta9on  archival  
nie.gov.in  

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 28/12/15  

Impediments  in  clinical  trial  participation  

HEALTH  RESEARCH  FUNDAMENTALS    

NIeCer  101                                                                                            
At  the  level  of  pa9ents  
•  Don’t  know  about  clinical  trials  
•  Don’t  have  access  to  clinical  trials  
•  May  be  afraid  or  suspicious  of  research  
•  Can’t  afford  to  par9cipate  

Na9onal  Ins9tute  of  Epidemiology  

Chennai  
•  May  not  want  to  go  against  health  care  provider’s  wishes  

At  the  level  of  health  care  providers  

•  Lack  awareness  of  appropriate  clinical  trials  
•  Be  unwilling  to  “lose  control”  of  a  person’s  care  
•  Believe  that  standard  therapy  is  best  
•  Be  concerned  that  clinical  trials  add  administra9ve  burdens  
nie.gov.in  

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