Real-World Evidence Has Its Price
Real-World Evidence Has Its Price
Real-world evidence requirements across all phases of drug development are increasing, and so are the associated research costs. Unfortunately, research dollars are not, and spending associated with even the simplest of protocol-driven data collection studies can be significant. Cost and time efficient evidence gathering across the product lifecycle has never been more important. Though peri and postapproval value demonstration studies vary markedly in terms of methodology and scope and scale employed (Figure 1), opportunities for savings and efficiencies can nevertheless be realized through strategic planning, knowledge transfer, and re-purposing of study materials.
Strategic and synergistic real-world evidence gathering across the product lifecycle can and will contribute significantly to cost and timeline efficiencies. With that in mind, we offer the following general recommendations:
- Engage in rigorous early value development planning and strategic evidence generation. A plan which clearly delineates the “right” data for the “right” audience at the “right” time will ensure that data collection efforts are focused and coordinated and contribute to successful reimbursement and market access outcomes.
- Consider the appropriate use of secondary sources of healthcare data as a means to identify a focused cohort of potentially eligible investigators and patients for participation in studies.
- Build a network of investigators who are committed to a well-described, scientifically rigorous, multi-year program of complimentary studies.
- Initiate network study sites with a mandatory core study protocol designed to achieve a standardized longitudinal core minimum dataset. Offer subsequent opportunities for new and existing sites to “opt in” to additional studies and sub-studies of interest through notifications communicated via the EDC infrastructure.
- Design studies in stepwise and strategic fashion, and strive to combine designs and research objectives into a common study protocol where possible. The integration of multinational chart review studies and disease and product registries are particularly well-suited to this synergistic approach.
- Establish a central repository of study documents and materials including protocols, e-CRFs, statistical analysis plans, data dictionaries, and coding to ensure optimal use and re-use of fixed cost investments.
- Offer participating investigators opportunities to access their own data electronically in real time. Benchmarking patient data within and across study sites through the use of customized reports and data visualization techniques can serve as an effective participation incentive by offering investigators important clinical information as well as opportunities to participate directly in study publications.
In summary, an early adoption and implementation of strategic study designs and operational infrastructures can provide important opportunities for significant savings in terms of commercialization timelines, costs, and human resources requirement.
Chris Pashos, Vice President, will be presenting, Efficient Real-World Data Gathering through Strategic Designs and Operational Infrastructures, at HNC Late Phase Drug Development World Americas this week.
For more information on how UBC can help support your product, please contact Krista Payne.