Posted on August 1st, 2019 by Xuanyan Xu in Pharma R&D
Advances in technology, increased investment in digital solutions and the creation of more powerful analytics are all contributing to a growing interest in utilizing real-world evidence (RWE) in drug discovery & development. Following up on my previous post that goes into detail on what RWE is and why the industry is increasingly drawn to it, I now want to discuss its role and impact in the drug development life cycle.
What is the Role of RWE in the Drug Development Process?
Real-world evidence, which is based on data that is
gathered during routine clinical practice, has the potential to make a
meaningful impact in nearly every phase of the life of a drug. That means RWE
is relevant to:
- Early discovery – “RWE has the potential to be used early in drug discovery and development programs, facilitating product development by identifying diseases or indications that represent a significant burden in populations,” explains this paper on real-world evidence, also noting the example of the NIH using electronic health records to support differentiation of patients’ needs.
- Trial design and feasibility – “Protocol authors need reliable and real-world information about patients, diseases, comorbidities, and concomitant treatments from routine medical practice (i.e., how patients present themselves in a true medical setting),” contends Clinical Researcher, explaining that real-world data makes it possible to design clinical trial protocols in a more “realistic” manner that includes creating a feasible set of eligibility criteria.
- Trial execution – McKinsey & Company points out that real-world evidence could have a significant effect on trials by allowing for the adoption of external control arms derived from historical or contemporaneous populations treated in a real-world setting. This evolution in how trials are run could potentially reduce the size, duration and cost of clinical trials, and could also make a particular difference in cases of rare disease where patient recruitment is especially challenging.
- Market access – In an interview with EyeForPharma on how RWE can be used at the market access stage, Michael Seewald, VP & Worldwide Head of Real World Evidence at Novartis, said, “We should recognize RWE as a key opportunity to gain an understanding of the disease and the real-world use and effectiveness of current treatments, including the value that products offer in certain subpopulations. In addition, Real World Data means patient-centric data for most of the data sources. It can enhance our understanding of the patient journey through their disease and of the overall outcomes for patients.”
- Post-market surveillance and studies – Post-approval studies and surveillance can be prohibitively expensive for drug developers. But, as ICON consulting services observes, “Integrating RWE and clinical trial evidence into an ongoing life cycle management strategy can greatly lessen the demand for, and cost of, post-market research.”
These are just a few of the ways that RWE can positively affect drug development, from improving treatments to cutting costs. in my next posts, we’ll examine real-world evidence from the regulators’ perspective.
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