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 […]
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 […]
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 […]
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 […]
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 […]
The world today is observing an exponential growth in the volume and variety of the real-world data (RWD). Thanks to the technological advancements and the rise in the use of integrated electronic medical records (EMRs), RWD is ever more accessible and applicable in the regulatory domain as well as outcomes research. The evidence from randomized […]
In a data-driven world, where everything can be digitalized, drug regulators and sponsors are increasingly looking beyond the confines of clinical trials. The use of real-world data (RWD) is becoming common in the clinical development process of a drug. RWD enhances the drug approval process, helps sponsors understand how a particular intervention really performs, and […]
The health and fitness wearable market is on the rise since the last few years. Analysts expect that by 2020, almost half a billion smart wearable devices will have been sold. However, despite the fast-growing market, only 10% of those consumers are using the product daily. This is an opportunity for innovative life science companies to […]
Real-world evidence (RWE) research is gaining significant importance in biopharmaceutical product development as well as its commercialization. The increasing need of the industry to seek broader information about the safety and effectiveness in the real-world setting, which typically impacts the ensuing reimbursement and utilization of new products, is determined by regulators, public and private payers, […]
