Real World Evidence

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 […]

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 […]

21Apr 2022

Real-world evidence (RWE) has been used extensively for satisfying post-launch regulatory requirements, mainly about drug safety. Of late, it has been realized that RWE has a wide range of applications across various phases of a product lifecycle, starting from the pre- to post-launch phases. These applications aim to address the particular needs of different healthcare […]

13Apr 2022

Artificial Intelligence (AI) refers to a computerized system that performs physical tasks, cognitive functions, solves problems, and/ or makes decisions without overt human instructions.[1] First proposed by McCarthy in 1955, the concept of AI has been applied in many health-related areas, including clinical research, hospital care, drug development, disease diagnosis, prognosis, and treatment monitoring. Advancement […]

08Apr 2022

A patient registry has been defined as “an organized system that uses observational study methods to collect uniform data (clinical and other) to evaluate specified outcomes for a population defined by a particular disease, condition or exposure, and that serves a predetermined scientific, clinical or policy purpose.”(1) Patient registries provide an infrastructure for the standardized […]