Introduction to the ISCR Councils
ISCR has seven functioning councils which constitute the major activities of the Society. Each of the Councils has a Council Coordinator and Members who drive the respective agenda of the Councils, guided by the overall objectives and mission of the Society.
About Real World Evidence Council
The field of clinical research globally has seen many evolution, all aimed at making the research outcomes efficient and more predictable. One such evolution is the key role that Real World Evidence (RWE) is playing in various phases of drug discovery, development and commercialization. RWE has now been intensifying throughout the product life cycle as the trend is changing from the past where RWE data were used mostly pre-launch or at product launch. We see today that RWE is being used effectively to take decisions not only in the early development of the drug development but also in regulatory decisions with regards to safety, effectiveness, health technology. RWE is also driving the execution of effective clinical trials by decreasing the time of phase III and in speeding up the regulatory approval procedures and post marketing safety surveillance.
To ensure that the clinical research professionals, organizations involved in clinical research and other important stakeholders of clinical research such as the ECs and the investigators are aware of this important aspect and are able to utilize it for having better patient outcomes, ISCR has launched the Real World Evidence Council.
The primary objective of this council is promote awareness and adoption of RWE in India, primarily in the following areas:
- To engage with the policy makers within the government particularly ICMR, senior bureaucrats associated with the Health Ministry, CDSCO etc. on the policy framework for RWE research in India which will help to strengthen the framework for helping health care providers in collecting, analyzing and using real world data for better patient outcomes.
- To conduct innovative training programs across the country for professionals and investigators on the key aspects of RWE research to create the awareness about the methodologies, outcomes and support in product lifecycle.
- Generate evidence for RWE in India in the form of case studies and position papers
Council Chair and Co-Chair
Dr. Mahendra Rai
Dr. Madhur Garg