Tremendous rise in new drug development cost every passing year, puts an extreme pressure on the drug discovery, leading to the need for evidence based data driven approach for clinical trials. Access to real-life data will facilitate generation of clinical evidence that may be better or equal to the results obtained by randomized clinical trials (RCT).

Real World Evidence (RWE) is the clinical evidence obtained by analyzing the Real World Data (RWD) collected through various sources, to mitigate potential risks, thereby deriving benefits of the study drug (investigational product, medical devices, surgical procedure etc.) mainly in terms of enhanced safety/ efficacy with reduced cost, may be to omit RCT.

The global RWE trend is expected to reach USD 1,348.1 million by 2023, with a CAGR of 14.3%. This acknowledges the fact that RWD/RWE holds the future of almost all types of prospective research.

Use of RWE data is preferred to by the regulatory bodies, insurance companies, payers, healthcare professionals to draw insights for better proficiency. There is a wide scope of integrating the goodness of RWE with the clinical trials for shorter, less complex and efficient clinical research operations. RWE makes use of patient’s health related observational data collected during clinical practice.

To derive maximum benefit, it is recommended to apply the principles of Clinical Data Science (CDS) on the data obtained at the source of its origin i.e. at various real world scenarios.

Data Science can help convert vast amounts of data generated by the digital sources into new predictive insights and knowledge repository.