Hybrid designs generate real-world evidence insights.
OXON performs single and multi-country observational studies and uses hybrid designs to achieve the optimal balance of validity, reliability, efficiency, cost, and practicality for our sponsor’s studies.
OBSERVATIONAL HYBRID DESIGNS
Hybrid research can be defined as the combination of qualitative and quantitative techniques, where a qualitative approach is utilized to uncover the meaning and attitudes behind quantitative data.
At OXON we define Real-World hybrid studies as those where more than one design or type of data source is used to address the specific objectives of an observational, non-interventional study.
Hybrid study designs can help generate real-world evidence, providing an alternative solution path to the challenges presented by observational studies.
HYBRID RETROSPECTIVE – PROSPECTIVE STUDIES
Hybrid study designs that aim to generate high quality data, collected in a rapid and time-efficient manner, may be an option when traditional approaches are not suitable.
These studies are composite designs that combine elements of two basic designs (e.g. cohort designs and case-control studies), or that combine elements of a basic design with elements of a non-observational design.
Hybrid designs generate real-world evidence insights. OXON provides single and multi-country nested case-control, case-cohort and case-crossover studies for a better understanding of results. Each approach has unique strengths and weaknesses. Combining these approaches allows for filling evidence gaps more effectively.
There are no formulae for hybrid studies
A hybrid approach helps overcome the limitations found in a single design or data source.
OXON uses hybrid studies to substantially improve the validity, reliability, or efficiency (time and cost), of studies for regulatory-imposed PASS and PAES studies.
• What works in one situation may not be appropriate in another similar situation, even in the same therapeutic indication (unlike the experience in clinical trials)
• What works in the US may not work in Europe, which has a variety of health care systems, medical practice, and differing data sources.
OXON has the required expertise to consider all possibly relevant combinations of data collection (prospective, retrospective chart review and cross-sectional) and secondary data (databases and registries) in Europe and balance the inevitable trade-offs between validity, reliability, practicality, time, and cost.
One area in which we are active is the use of historical data (via retrospective chart review and secondary data in registries and databases) for one-arm pre-approval and post-approval clinical trials of orphan conditions to provide non-current control group and devise clinical endpoints, as well as to characterize natural history and treatment and clinical management patterns.
CASE STUDY 1
Hybrid prospective data collection and database PASS study – approved by MHRA (protocol available):
• Mapping and harmonisation of the prospectively collected data with the data available in the linked database, and the various limitations in comparability for the primary objectives and covariates.
• How to use the adjudication committee assessed events and align with defining events in the database.
• The hybrid design led to the sponsor fulfilling the regulatory obligation within timeframes, which a traditional design was less unlikely to accomplish
• Reliability: Increased statistical power to address the study objectives
• Cost Saving: Sponsor saved more than 0.5 million Euros.
CASE STUDY 2
Hybrid retrospective chart review and patient survey approved by EMA (protocol available):
• Avoidance of use of relatively cheap patient panels which are not representative and likely to produce biased results.
• Linking the survey respondents automatically with the retrospective chart review abstraction, done by using OXON’s proprietary validated EDC, built specifically for observational studies and flexible to be readily adapted for hybrid designs.
• Relevance: Linkage of process survey indicators with clinical and safety outcomes to improve the relevance of survey data, as requested by regulators.
• Reduced burden: Sponsor was permitted by the regulatory agency to remove the additional risk minimisation material.