Prediction of placebo response in Osteoarthritis improves estimation of the treatment effect: Impact on drug development

March 11, 2021

Placebell©™ can be used in OA and similar diseases in which efficacy is characterized using patient-reported outcomes to reduce the interference of the placebo effect and improve assessment of the drug effect. The performance and applicability of PlacebellI©™ has recently been demonstrated in a Phase 2 RCT conducted by a biotech sponsor in subjects with moderate to severe painful knee OA.

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The placebo response – a phenomenon related to the placebo group or to the individual patient?

February 8, 2021

Historically, interpretation of clinical trials relies on “assay sensitivity”, or the sensitivity to detect clinically meaningful differences between endpoints measured in the group of patients given active drug compared to the group of patients given placebo. Assay sensitivity can be influenced by many factors, including the study design, specific endpoints selected, number of clinical sites and, of course, the magnitude of the placebo response.

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From covariates to confounding factors: the danger of having too many covariates

October 20, 2020

Clinical trials typically evaluate efficacy of experimental therapies in heterogeneous patient populations, as patient characteristics vary significantly. These patient characteristics might be prognostic factors that ultimately induce variability in clinical trial data. An imbalance in these factors between treatment groups at baseline will increase variability of the estimated treatment effect, ultimately compromising study power and decreasing

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Regulatory Guidelines for the Use of Baseline Covariates to Increase Clinical Trial Study Power

October 15, 2020

Clinical trials data analyses can employ baseline covariates to control for factors that may impact measurement of outcomes – particularly to describe individual patient characteristics that may or may not relate to treatment response. For example, patient age may be used as a baseline covariate to reduce data variability resulting from this factor. The use of baseline

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Does the placebo response need to be considered in clinical trials for COVID-19 vaccines and treatments?

September 22, 2020

The search for drugs to treat and prevent SARS-CoV-2 infection is ongoing, with more than 1200 drugs in the pipeline and more 3,200 clinical trials planned or initiated as of 21 September 2020 (GlobalData). The success of these studies, however, may be at risk due to an invisible threat – the placebo response.

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Frequently asked questions about COV-IQ

September 16, 2020

This webinar aimed to explain the impact of COVID-19 crisis on patient behavior in ongoing clinical trials, introduce the application of COV-IQ technology and describe how it may improve interpretation of clinical trial results. During the webinar, questions from the audience were addressed; the main ones are compiled below.

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Pandemic Stress Will Affect Clinical Trial Response: What Can Industry Do?

July 29, 2020

As one might expect, the life changes are a source of stress, and the data supports this assertion. In fact, a recent analysis by Express Scripts also showed an increase in prescriptions for medications to treat anxiety, depression and insomnia as a result of the pandemic.

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The Placebo response in drug development Part 3: Parkinson’s disease

July 16, 2020

Parkinson’s disease (PD) is a chronic, progressive neurodegenerative disease characterized by both motor and non-motor features. The disease has a significant clinical impact on patients, families, and caregivers through its progressive degenerative effects on mobility and muscle control.

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The placebo response in drug development. Part 2: Osteoarthritis

June 18, 2020

Osteoarthritis (OA) is common musculoskeletal disease with increased incidence and prevalence associated with aging. It affects around 10 % of the population and is 10 times more common than rheumatoid arthritis (RA).

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Are clinical trials patients’ reactions to crisis related to their personality? Application to the COVID-19 pandemic.

May 1, 2020

Not only are patient visits to clinical sites more difficult (or impossible), patients are also dealing with uncertainty, stress and anxiety. While keeping ongoing trials running is a top objective for many, understanding how this myriad of factors will affect trial data is paramount.

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