Both electronic health records (EHRs) and patient registries store and use patient-related clinical information. However, they are conceptualized for different purposes. Both are a significant source of real-world evidence (RWE) […]
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 […]
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, […]
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 […]
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 […]
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 […]
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 […]
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 […]
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, […]