Insights
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.
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.
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
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
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 of clinical pain can be expected to have higher placebo response.
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 the mandate to listen to patients, caregivers, or advocacy groups to better understand the unique needs of a specific patient population. They may include ensuring that the outcomes measured