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International Clinical Trials

Redefining the Gold Standard

Adaptive clinical trials have risen in popularity and gained more attention since the FDA Critical Path Initiative (2004) and Critical Path Opportunity List (2006) called for innovative solutions to transform the way medicinal products are developed, evaluated, and manufactured. They are now being commonly used to quickly predict the likelihood of the success or failure of a drug in early stages of drug development.

The release of the FDA’s draft guidance in 2010 on “adaptive design clinical trials for drugs and biologics” provided a suggested framework for designing such studies and for using them to make decisions that would allow the innovator to “fail early.” EMA’s Committee for Medicinal Products for Human Use released a similar draft in 2006 (1).

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Dr Chitra Lele is Chief Scientific Officer at Sciformix, a Covance Company, with over 20 years of experience in the healthcare industry. She has been part of the company’s leadership from its inception and has been instrumental in establishing and growing the organisation. Prior to Sciformix, Chitra was Executive Director responsible for Indian operations of Pfizer Global R&D. With a PhD in statistics from Stanford University, US, her prior experience includes work as a biostatistician in cancer epidemiology at both Stanford and University of California, US.

Dr Ritu Budania is a Drug Safety Physician for global medical safety operations at Sciformix, a Covance Company. She completed her MBBS from Topiwala National Medical College, India, and MD Pharmacology from Government Medical College, India. Ritu has assisted in preparing ‘Desk View Clinical Trials in India’ for the WHO and prepared signal reports for Pharmacovigilance Programme of India (PvPI). She was in charge of the adverse drug monitoring centre under PvPI, at King Edward Memorial Hospital, India. Ritu has expertise in pharmacovigilance, clinical pharmacology, medical writing, clinical research, and clinical trials. She is also an experienced industry guest speaker in the subject of pharmacology.
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