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, […]
Traditionally, the pharmaceutical industry has always been dependent upon the ‘push’ strategy for successful market access for products. The drug approval process, involving submission of data on efficacy, safety, and tolerability to the regulatory agencies, used to be simple; which ended with the drug being marketed to the targeted physicians and dispensed by pharmacies post approval. Thus, this whole process involved a limited set of stakeholders, viz. physicians, regulatory agencies, and pharmacies.
Traditionally, the pharmaceutical industry has always been dependent upon the ‘push’ strategy for successful market access for products. The drug approval process, involving submission of data on efficacy, safety, and tolerability to the regulatory agencies, used to be simple; which ended with the drug being marketed to the targeted physicians and dispensed by pharmacies post approval. Thus, […]
The term real-world evidence (RWE) commonly applies to data generated in non-randomized clinical trials (RCTs) in a healthcare setting, which sometimes also covers patient socio-economic data and environmental data. Irrespective of the definition, RWE offers significant advantages over RCTs that have well documented limitations, despite being recognized as the gold standard for evidence-based medicine. Today, […]
Missing data are a big concern in any research project and are often unavoidable in spite of investigators’ best efforts. Missing outcomes have two effects: reduced precision and power, and bias. Also, the loss of precision is inevitable, except the possible use of the available data; e.g. to be sure not to exclude from the […]
Workshop title – “R WE Ready?” – “Real World Evidence” Methods! Organisers – Co-organised by Organisation of Pharmaceutical Producers of India (OPPI) and ISPOR India-Mumbai Chapter Objectives – To enhance skill set of the professionals of the medical affairs community in area of real world evidence generation to […]
