Investigator and site selection and performing GCP clinical studies in India.
The optimum site and investigator selection process remains a closely guarded confidential matter and an essential part of development expertise of big pharmaceutical companies and CROs. The right and careful selection and evaluation of investigators and site is critical for successful completion of the trial within budget, timelines and generation of high quality data. The criteria for site and investigator selection in India for Good Clinical Practices (GCP) clinical trials are described for a start up company/CRO and can be applied to any country in Asia and Africa. Foreign sponsors doing clinical studies in India should pay close attention to site and investigator selection. The first GCP study in India was done only in 1995. At the dawn of 21st century, India is at the take off stage in clinical trials now. GCP studies can be done in India, as the quality of data is good, costs are lower and patient enrolment is much faster resulting in early completion of studies.
Maggon
Krishan
K
Pharma Biotech R&D, P.O. Box 1887, ICC-20 Route de Pré Bois, 1215, Geneva 15, Switzerland. maggonk@lycos.com
D002755:Choice Behavior; D006761:Hospitals; D006801:Humans; D007194:India; D018579:Patient Selection / Q000941:ethics*; D016032:Randomized Controlled Trials as Topic / Q000941:ethics*; D012108:Research Personnel / Q000706:statistics & numerical data*