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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…
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…
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…
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 –…
The placebo problem in pain: does baseline pain variability predict placebo response?
Recent reports have demonstrated a positive correlation between baseline pain variability and improvement in clinical trial patients receiving placebo, suggesting that patients with more highly variable reporting…
Patients are people: a new take on patient-centricity
If you ask a dozen people in the pharmaceutical / biotech industry what the term “patient-centricity” means, you’re likely to get a dozen different answers. These may include…
Understand patient differences in your next clinical trial
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