The placebo problem in pain: does baseline pain variability predict placebo response?

May 11, 2022

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

March 3, 2022

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

February 2, 2022

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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Should strong placebo responders be excluded from clinical trials?

November 16, 2021

Using Predictive Modeling to understand the impact on assay sensitivity The placebo response is a heavily studied and historically challenging phenomenon for drug developers. Strong placebo effect diminishes the ability to distinguish efficacy of an experimental drug, leading to phase II and III trial failures1– even for otherwise effective drugs.  Researchers have long devised strategies

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How much of the measured treatment response in clinical trials is due to the placebo response?

September 17, 2021

Clinical trials measure efficacy of experimental therapies by comparing outcomes in patients receiving therapeutic interventions (treatment response) with patients receiving placebo (placebo response).

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The Importance of Patient Psychology in Health and Clinical Research

July 9, 2021

When we think about patient characteristics that influence health, disease, and clinical research, we tend to think about things like vital statistics, medical history and genetic makeup – while patient personality or psychology is often overlooked. In reality, the importance of personality has been under scrutiny for centuries and dates back to Greek and Roman times

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