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The Vital Role Real World Evidence Plays in an Integrated Evidence Strategy
Adding value for all stakeholders throughout the drug development and commercialization lifecycle
Jul 16, 2021
The pharma industry talks a lot about the value of using real world evidence (RWE) in drug development. During the research phase, RWE can be used to define more relevant protocols and inclusion/exclusion criteria, to select sites with the greatest access to patients of interest, and to build a more powerful case for regulatory approval and payer support.
RWE can be equally valuable to commercialization efforts, helping sales and marketing teams understand how, when, and why physicians prescribe a drug, what drives adherence, and what outcomes are experienced by different patient sub-populations. These insights can help them craft more targeted campaigns and sales strategies, and identify opportunities to engage healthcare providers (HCPs) in ways that drive stronger uptake of new products.
But to get the most value from RWE, developers should stop just seeing it as an ad hoc solution to solve a specific need, and start treating RWE as an integral component of evidence strategy that affects every key milestone, from early research, through commercialization.
When RWE is integrated into the entire product lifecycle, developers can draw more value from the data they collect and acquire while reducing redundant data collection efforts, and avoiding evidence gaps.
Three drivers for integrated RWE strategy success
An integrated RWE strategy harmonizes evidence collection with three vital and interconnected pieces.- Stakeholder needs
- What payers want to see in price and access negotiations - Developers can use RWE to help payers understand the value differentiation of their product related to long-term healthcare costs, links between adherence and reduced hospital stays, and cost of care comparisons to competing products.
- What HCPs want to see to better treat their patients - HCPs want RWE that will help them identify under-diagnosed patients; understand the real world efficacy and risks of a product to their patient demographics, compared the benefits of the product to competitors; and, see how it aligns with their prescribing preferences.
- What patients care about - RWE can provide patients with real world context about the impact of a treatment, including whether it will improve their quality of life and longevity, what side effects they can expect, and what it is going to cost them in the short- and long-term.
- Sources of evidence
- Timing of evidence collection
- What RWE will regulators want to see in a submission package?
- What RWE can support value-based pricing to secure market access, including innovative contracting and managed entry agreements?
- What RWE may be needed to expand access or approve additional label claims?
- What RWE will be of interest to HCPs and patients as they consider their treatment options?
- How can RWE be used to identify future patients or to support recruitment into future trials?
The first step to building an RWE strategy is identifying the data needs of every stakeholder across the entire asset journey.
Typically, developers build their RWE strategy around what regulators want to see in a submission package. While regulators remain important, they are not alone. An effective use of RWE in your evidence strategy will also consider the following.Each stakeholder will require different kinds of RWE gathered from different global and regional sources. These sources can include secondary data gathered from existing electronic medical records (EMR), pharmacy claims, and patient registries, which can help developers understand the general experiences of patients.
Developers can also conduct their own primary RWE studies to evaluate the disease journey, and to assess the effectiveness, safety, and/or health-economic benefits of a treatment in real world settings. These studies can be used to answer specific questions, but require upfront planning to get them completed in time.
When choosing sources of evidence, it is important to consider where the data will come from, who owns it, what questions can and cannot be answered from that source, and the time and cost required to capture it. In rare diseases or those with limited available data, developers will likely have to use multiple sources of RWE to fill knowledge gaps.
Whether a team is using secondary datasets, like EMRs and prescription data, or conducting their own studies, they need a plan for acquiring/analyzing the data so that it is available at the time of need.
That requires an RWE plan created as part of the drug development process, that considers what data will be needed when, how long it will take to acquire, what it will cost, and who is responsible for gathering it.
The plan should link specific data to key milestones in the development lifecycle, and extend beyond the product launch, to consider the commercialization needs of the product and future development initiatives. When building this plan, developers should considerCollaboration is the key to success
RWE can add value to every stage of the drug development and commercialization lifecycle. But to integrate RWE successfully into evidence strategy, operational barriers that may prevent collaboration must be removed, and teams must be incentivized to collaborate over a shared vision of the asset.
When the silos are dismantled, teams take an end-to-end view of RWE collection, analysis, and use that can accelerate successful development and improve uptake in an increasingly competitive marketplace.
Webinar On-Demand: Real World Evidence. Real Results.
To learn more about this and other topics, we invite you to watch the on-demand session, “How integrated evidence generation and patient-centered strategies maximize RWE impact.”