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Blog
6 Steps for Building a Successful RWE Strategy
Oct 06, 2020
Pharmaceutical organizations have many opportunities to drive value using real world evidence (RWE) across the development and commercialization lifecycle. When they incorporate real world data sources into their overall development plan, they can accelerate recruiting, support single-arm trials, enhance regulatory submissions, and demonstrate real world effectiveness post-launch. All of this can lead to significant time and cost savings, while improving the patient experience.
IQVIA’s experience of working with RWE has indicated that:
- Using RWE studies to determine the long-term value of a treatment to patients after a clinical trial costs roughly 60% less than site-based approaches.
- Pragmatic RWE studies to evaluate the effectiveness of a clinical trial intervention in real world conditions can cost 50% less than clinical studies, and are also useful for label expansions.
- Enriching clinical trial studies with primary and secondary real world data increases trial efficiencies and reduces burden on patients.
- Using real world data as comparative evidence for single-arm clinical trials can allow for meaningful benchmarks versus standard of care, even when a randomized controlled trial is neither ethical nor feasible. The number of payor submissions referencing single-arm studies has grown tenfold in recent years, and studies show the use of external comparators in these submissions is associated with an increased rate of approval or label expansions.
IQVIA has seen the positive impact of these studies across our clients’ drug development programs. In one example, a large pharma company asked IQVIA to review its late-phase portfolio to identify opportunities where RWE could generate efficiencies. After evaluating each study based on its location(s), purpose, design freedom, and use of secondary data, our experts determined that RWE-based design changes could generate 15% in overall savings, with some studies projecting a ~40% savings through the use of RWE. That translated to millions of dollars in potential savings.
However, such benefits can only be achieved if pharma companies establish an RWE strategy early in the drug development lifecycle, and incorporate insights from across business functions as they build their plan. This collaborative approach is vital to avoiding the siloed decision-making that often gets in the way of innovative RWE strategies.
6 steps for building a successful RWE strategy
Whether you are building an RWE strategy for a particular project, or as a baseline approach for the entire organization, these six steps will give you a roadmap for success.
- Bring together representatives from across relevant clinical, commercial, financial, and regulatory functions to jointly craft an RWE strategy.
- Identify evidence questions that must be addressed to satisfy regulators, payers, physicians, and patients.
- Review existing and accessible real world and clinical data sources in each relevant region, and determine which ones could help answer those questions.
- Identify evidence gaps that are not currently met and will require additional data generation through real world studies.
- Prioritize which gaps to address in what order, and what types of data or studies will close the gaps.
- Establish a plan that covers the data collection methodologies to be used, tangible next steps, and anticipated timelines and budget.
IQVIA can help you analyze and understand the ever-expanding ecosystem of clinically-rich data in the context of your organization’s needs. By combining advanced analytics with unparalleled data and scientific expertise, IQVIA provides customers with innovative Real World Evidence approaches to meet stakeholder needs throughout the product lifecycle.
To learn more about how to create an effective RWE strategy, including innovative design models, and technologies to accelerate results, contact us, or listen to the IQVIA webinar, Real World Evidence Strategy for Specific Therapy Areas.
eBook: Explore Transformative RWD Sources
Discover how you can leverage RWE to accelerate study timelines, shorten time to market, cut research costs, and more. In this interactive eBook, read case examples on how key client questions were answered in various therapeutic areas and glean insights on how you can use RWD to answer challenging research questions.