Insights
Global Reach, Local Understanding: Cognivia’s Participant Questionnaire Validated in Over 50 Languages for Comprehensive Clinical Trials
For high quality clinical trial data, the voice of the participant (i.e. patient and/or caregiver) must be captured in the language that they can understand. In this blog post, we discuss the linguistic validation process of the participant questionnaire behind Cognivia’s clinical trial technology.
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Expectations of Improvement in Clinical Trials: site or patient related?
There are multiple techniques to account for these expectations in studies, including site stafftraining, subject training before the start of the study, and applying an adjustment covariate.
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The FDA highlights the tools to enhance the precision of primary analyses in clinical trials.
The FDA released its final guidance regarding the use of covariates to improve the precision of statistical analyses in clinical trials on 26 May 2023. It is a major step forward in the statistical analysis of clinical trial data. Recognizing that nearly a decade ago, the publication of the EMA guide initiated the movement, the FDA has crystallized the concept with the current guidance.
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The Placebo response in drug development Part 6: Allergy & immunology
The placebo response is widely known to compromise evaluation of pain endpoints and has been suggested to contribute to as much as ~2/3 of the measured treatment effect in pain from various etiologies, contributing to the high rate of Phase II and III clinical trial failure in this indication.
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The Placebo response in drug development Part 5: Pain
Placebo-controlled clinical trials are the gold standard in drug development, in part to ensure that the efficacy of a new therapy exceeds the placebo response in the indication being studied. The placebo response is a measured improvement in clinical signs or symptoms that occurs in patients receiving a sham (or “dummy”) treatment. The placebo response is a
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The Power of Placebo & Trust for Pain Management
A growing body of work has demonstrated that pain perception can be modulated by social, cultural, contextual and interpersonal factors.1,2,3,4 Beyond this, patient trust in their doctor – an important component of the doctor-patient relationship – has been shown to positively influence patient health outcomes. A growing body of research is also showing that the placebo effects have
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