Holy Family Hospital & Medical Research Centre
 
About Us OPD Patient Guide Other Services
 
  AFFILIATION
Holy Family Hospital & Medical Research Centre
HomeAffiliationMedical Research SocietyDrug Trials Text Size  
 
Drug Trials
Drug trials form an important part of clinical research in India. Clinical research is any investigation in human subjects whose objective is to discover or verify the effects and side-effects and / or to ascertain the efficacy and safety of any new drug for a disease. It is an elaborate part of a new drug discovery process.

The clinical research process is conducted in four phases. In India, they are undertaken for new drugs in Phase 2, 3, and 4 of drug development for the US FDA (Food and Drug Administration) and DCGI (Drug Controller General of India) approval.

Drug trials are at the cutting-edge of clinical research as they provide new treatment strategies with drugs or devices for various disorders. Previously, drug trials were mandatory as a part of process approval by the DCGI for any new drugs approved abroad to be marketed in India and also to conduct Phase 4 or Post-Marketing Studies to collect additional safety data after the drug was marketed.

The trend in recent years has seen India as a place for conducting Phase 2 and Phase 3 drug trials US FDA for newer drugs, new indications, and in newer age groups as a part of Multinational and Multicentric International Drug Trials.

All trials are undertaken under the supervision of and follow the guidelines laid down by the FDA, DCGI and Indian Council for Medical Research. They are also ICH GCP (International Conference on Harmonisation: Good Clinical Practice) compliant.

Guidelines
The Holy Family Medical Research Society jointly with the Holy Family Hospital participates in clinical research across specialties. All clinical research undertaken by us is under the US FDA and DCGI. The research is conducted according to and under the guidelines of:
  1. ICH GCP 1997, a universal guideline adopted across the world including the US FDA and European Union
  2. Revised Schedule Y (2005) of the Drugs and Cosmetic Act, 1940
  3. Ethical Guidelines for Biomedical Research on Human subjects, 2006
  4. Good Clinical Practices 2001 (Indian GCP)
  5. ICMR
These yardsticks are applied by the Scientific Committee and Independent Ethics Committee of the HFH Research Society when evaluating research project proposals submitted to the Society.

Drug Trials at HFH

The following drug trials are approved and underway at the Research Centre for the year 2014 - 2015
  • Dr Brian Pinto - 11 Clinical trials / registry in Cardiology and 3 awaiting start
  • Dr Yash Lokhandwala - 1 Clinical trial

  Top