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Shifting Data Closer To The Patient
Strategy-Driven Data Design Leads To Better Data Collection Methods
Sep 20, 2023
The volumes of data generated during clinical trials continue to rise, with drug companies gathering hundreds of terabytes of data per year across all phases of research and development. The wide availability of data collection devices, eSource and electronic data capture may tempt sponsors to gather more data than is truly necessary. This can add unreasonable burdens for sites and study participants alike. A well thought-out data strategy can balance the needs of all stakeholders by focusing on collecting only the data that is required to answer the questions underlying the protocol design.
The statistical design of the protocol is a key element of this data strategy. Statistical design involves questions about patient-related elements such as possible treatment effects, the best target patient populations, suitable inclusion/exclusion criteria, and whether adaptive or other specialist designs might be appropriate. Thoughtful design can enable data collection to move closer to the patient, reducing the burden of participation, minimizing exposure to experimental compounds, and ensuring that the right set of patients is targeted for treatment. Multiple trends are driving the adoption of innovative trial designs, including regulatory acceptance, potential to reduce sample sizes, minimizing design and execution risk, and patient centricity. As a result of these benefits, adoption of innovative clinical trials design has increased over the last decade or so, from 4% of trial starts in 2010 to 8% in 2021. Adoption is particularly strong in oncology-related studies.
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