Insights
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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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.
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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
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Predicting the placebo response in quality of life, sleep and fatigue
While significant placebo responses rates are often noted in clinical trials for indications like pain and depression, this issue can plague drug development in any therapeutic area – particularly in diseases that rely on subjective or patient-reported outcomes as primary efficacy endpoints. Quality of life (QoL) endpoints, for example, are often used to measure therapeutic efficacy in oncology clinical trials – but also in diseases like schizophrenia, pain, heart failure, inflammatory bowel disease (IBD), allergy and pruritus.
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