Real-world evidence (RWE) research is nowadays a necessity of biopharmaceutical product development and commercialization.
Several major reasons are listed below:
- 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.
- Data about real-world patient experience also has the potential to improve the quality and delivery of medical care, reduce overall costs and improve outcomes by accelerating the understanding of how best to incorporate new therapies and technologies into everyday clinical practice. These data help fill the knowledge gap between clinical trials and actual clinical practice.
- While clinical trials remain the gold standard for drug approval, more information is needed on how specific drugs perform within different age groups, such as the elderly, and different genders, races and ethnicities, as well as differences in disease severity and unstudied co-morbid conditions for use of products in the real world.
- 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 protocol.
- The EMEA guidance requires the collection of risk-benefit data in post-authorization safety studies. Pharmaceutical companies now must take a more granular approach, examining different subpopulations to determine their respective risk-benefit balance.
- There is also an increasing demand from payers to conduct observational studies on a new product’s effectiveness, and payers and clinicians are eager for more detailed health outcomes data to inform prescribing and reimbursement decisions.
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