Stakeholders often require evidence generated from real-world settings to make decisions regarding treatment, coverage and reimbursement. This is most evident in the recent passage of the 21st Century Cures Act, which requires the Food and Drug Administration (FDA) to develop guidance for the use of real-world evidence (RWE) in regulatory decisions on new indications and post-approval requirements for existing medical products.
RWE is derived from the aggregation and analysis of realworld data (RWD). According to FDA authors of a recent New England Journal of Medicine article, RWD is collected from sources outside traditional clinical trials, through observational studies such as databases (electronic medical records and administrative claims, for example), chart reviews, product and disease registries, and prospective studies with or without interventions (visits, procedures, tests and so on). RWD can also be collected from pragmatic trials with a post-randomisation standard of care.
Improved technologies and the availability of platforms for patient identification, access and data capture open the door to innovative and efficient study designs to collect RWD virtually. Through consultation and collaboration, Covance experts determine the best study design to meet its clients' RWE needs. It seeks to challenge the traditional site-based paradigm by integrating virtual components into otherwise traditional study designs. As part of LabCorp, Covance can reduce the burden on investigators by collecting samples at LabCorp patient service centres when routine or esoteric laboratory tests are required.
No matter where a product is in its life cycle, Covance works with its clients to maximise their product's commercial value. Part of this includes collecting and analysisng RWD and producing RWE for its clients. Covance Market Access works with clients to develop a complete market access strategy beginning as early as phase I. Covance can assess a client's market landscape, conduct research and communicate findings to help demonstrate value, augment clients' teams to help communicate their message, and support clients' patients, customers and overall access strategy. It offers solutions in five broad categories: access and strategy, evidence generation, value communication, patient support, and field services.
The goal of its outcomes research strategies is to ensure that its clients are on track to develop evidence to demonstrate the comparative value of their products and to meet the needs of patients, payers, providers and other stakeholders at launch.
Covance Market Access experts work with clients to develop evidence to support their value proposition. Companies need to demonstrate more than just clinical efficacy and safety to secure reimbursement in today's marketplace, and those looking to do so should turn to the experts at Covance Market Access to help generate the evidence needed to optimise value.
An ever-changing array of economic drivers, decisionmakers, reimbursement models and regulations may impact the commercial value of companies' products in today's marketplace. The earlier a company begins developing its strategy, the greater the potential reward, and the more Covance can do to help its clients achieve their goals.
It's never too early for a company to start paying serious attention to this area, and to begin customising an optimal study design for its RWE needs.