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Real World Evidence

Real World Evidence in the Real World

May 27th, 2016 - 0 Comments

Abraham Lincoln once said “The best way to predict your future is to create it”. We, Focus Scientific Research Centre team, a part of phamax, predict and create the future in the real world with our studies on real world evidence. Real-world evidence is now becoming the foundation for new pricing strategies which are more explicitly linked to therapeutic value for patients and health outcomes benefits to health systems and risk-bearers. With healthcare moving in a direction which is looking more at patient outcomes and less at targets, the pharma industry has also started to include patients alongside prescribers and payers in its thinking. Biopharmaceutical sponsors, providers, payers and regulators are eager to investigate real-world data for insights that can increase quality, drive down costs and improve patient safety.

The real world evidence world also includes patient registries, defined as “a file of documents containing uniform information about individual persons, collected in a systematic and comprehensive way, in order to serve a pre-determined scientific, clinical or policy purpose” by the WHO. In brief, a patient registry is a collection – for one or more purposes – of standardized information about a group of patients who share a condition or experience. The use of “patient” in patient registries often distinguishes the focus of the data set on health information. Currently, there is no consistent definition of the term “patient registry” used in the health research field. Terms such as clinical registries, clinical data registries, disease registries, and outcomes registries are also used to describe the same data collection method

Patient registries have been promoted and praised in both chronic and rare disease practice communities, and debated among comparative effectiveness researchers as to whether they provide valid data to compare treatments. Patient-generated registries in particular have been criticized on several levels, including the concern that only a small minority of patients with sufficient education and ability are able to participate, and that data may be biased for a variety of reasons. Despite these concerns, patient registries have yielded a significant amount of research that meets the needs of patients and families

Real-world evidence (RWE) research is an increasingly important component of biopharmaceutical product development and commercialization. The growing industry need for broader information on real-world effectiveness and safety – both of which will impact the eventual reimbursement and utilization of new products – is driven by regulators, public and private payers, and prescribers, all of whom seek to better understand the impact of a new product in a real-world setting. Compared to clinical trial data, RWE data more closely describes how the product will perform in a broader, more representative population over a longer timeframe, and provides information on comparators and outcomes that are not part of the clinical trial.

In the future, a lot of thought will go into the ways that real world data can be collected. There are the traditional methods using existing healthcare databases and registries, but there will always be new methods. Real world evidence is here to stay and represents an unprecedented opportunity to engage with and collect big data representative of the way that healthcare is utilised.

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