Real-world evidence: advancing drug development in oncology

Early design:

• Using robust genomic sequencing data and longitudinal clinical data, RWE analyses can identify biomarkers of therapeutic response and resistance to optimise a drug development strategy

Trial design and feasibility:

• Targeted use of RWE derived from electronic prescribing records (EPR) supports the design and optimisation of clinical trials. RWE can be used to design a trial protocol that is generalisable to standard of care, assess the impact of eligibility criteria on trial feasibility, and inform the selection of trial sites

Trial execution:

• Of particular relevance to oncology is the adoption of external control arms which may reduce trial size (that is, required number of patients), duration and cost. The traditional control arm, which provides a comparator to the experimental therapy, may evolve into an “external” control derived from historical or contemporaneous populations treated in a real-world setting

 

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About SVMPharma

SVMPharma is an innovative strategic consultancy, specialising in Real-World Evidence (RWE) for the pharmaceutical industry. SVMPharma generates RWE within UK and Europe through bespoke online Real-World Treatment Evaluators, leading to successful health technology appraisal (HTA) submissions. Clinical trial programmes do not reflect real-world clinical practice and outcomes, RWE supplements and enhances clinical datasets. SVMPharma’s specialist teams focus on delivering the outcomes that matter to your brand.

For more information, please visit www.svmpharma.com and contact us at enquiry@svmpharma.com

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