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25Jul 2022

Randomized controlled trials (RCTs) are the mainstay of clinical research; it is estimated that about 18,000 RCTs are published each year. However, traditional RCTs usually take a long time to complete, are expensive, and the results are challenging to generalize to the real-world since they are derived under ideal conditions with strict inclusion and exclusion […]

21Jul 2022

Evidence from randomized clinical trials (RCTs) continues to be the standard reference point for treatment efficacy across the world. However, RCTs enrol patients based on strict inclusion and exclusion criteria, and hence RCT evidence is often not generalizable and inadequate for contributing to the day-to-day clinical practice decisions. Consequently, researchers are more interested in using […]

27Jun 2022

Concerns about the consistency of the post-marketing surveillance (PMS) for safety of medical devices is well known across the world. Only around 13% of post-marketing surveillance (PMS) clinical studies are completed on medical devices.[1] This is because new products or line extensions are launched frequently, even before full clinical trials of the parent device are […]

31May 2022

With all stakeholders increasingly realising the value real-world evidence (RWE) studies can bring into the healthcare delivery, newer applications of RWE are being discovered with each passing day. RWE has the potential to tremendously enhance the speed of patient access to new drugs. With this background, it is absolutely essential that the quality of RWE […]

28May 2022

Real-World Data (RWD), from which Real-World Evidence (RWE) is generated, has the unique capability of depicting real-world outcomes. RWD can also reduce timelines for research and development, and generate profound insights into the disease process. However, RWD from a single source often suffers from bias relating to equipment, lack of phenotypic diversity, limited training models, […]

25May 2022

The USFDA defines real-world data (RWD) as ‘the data relating to patient health status and/or the healthcare delivery that is routinely collected from a variety of sources’, and real-world evidence (RWE) as ‘the clinical evidence regarding the usage and potential risks/benefits of a medical product obtained from analysis of RWD.’[1] RWD includes data from electronic […]

23May 2022

There has been a shift in the global healthcare ecosystem from volume-based to value-based payment model, thanks to a surge in data availability, interoperability, advancing health technologies, cost and competitive pressures, scientific advances, and increasing adoption of personalized medicine. The resulting availability of a large quantity of real-world data (RWD) has made it possible to […]

06May 2022

Real-world evidence (RWE) is derived from real-world data (RWD) sources, such as electronic health records (EHRs), claims data, data from product/disease registries, pharmacy data, social media, and pragmatic trials. RWE provides essential insights into the clinical experience, thereby complementing the information obtained from traditional randomized controlled trials (RCTs).(1) RWE has been extensively used for post-marketing […]

27Apr 2022

Drug makers usually put in rigorous efforts to fast-track and reduce the cost burden of regulatory decision-making by regulatory authorities like USFDA and EMA. As a part of these efforts, the interest in utilizing real-world evidence (RWE) for the approval process has considerably increased in the past few years.(1) Even though data from randomized controlled […]