Measure the right thing well
TwoLegs Consulting helps clients take an integrated approach to evaluating clinical benefit and demonstrating value on relevant and meaningful endpoints. Too often, the assessment strategies rely on ‘traditional endpoints’ to get approval. These ‘traditional endpoints’ tend to have conceptual or measurement flaws, and generate results that are difficult to translate into a clinical benefit, which is meaningful to patients.
- Design clinical outcome assessment strategies to evaluate benefit and demonstrate clinical value
- Review and select clinical outcome assessments that will provide meaning beyond statistical significance
- Lead development of well-defined and reliable clinical outcome assessments (PRO, ObsRO, ClinRO) to inform about how patients feel and function
- Advise on the implementation of clinical outcome assessments in adequate and well-controlled investigations to provide substantial evidence of treatment benefit
- Prepare and defend regulatory evidence dossiers to gain approval and support labeling language (FDA and EMA)
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