Insights

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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Data Integrity in GCP environment

April 6, 2020

As clinical trials become more complex, are conducted at more sites with multiple vendors (clinical sites, CROs, e-PRO, data management vendors, etc.), properly protecting data integrity becomes increasingly critical.

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The Placebo response in drug development. Part 1: Rheumatoid Arthritis

March 5, 2020

Evidence has accumulated in recent years that the placebo response is a significant issue in evaluating efficacy of drugs for rheumatoid arthritis (RA). RA is a chronic disease characterized by inflammatory synovitis and progressive joint destruction.

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The Opioid Crisis in the US: Fueling the Next Wave of Drug Development for Chronic Pain

February 18, 2020

While the opioid crisis may be creating opportunity for development of novel therapies to treat chronic pain, drug development in this area has historically struggled. According to a BIO report released in 2018, only two novel NCEs were approved for pain indications from 2007-2017 while other analgesia approvals during this period were reformulations of existing compounds or drugs with approval history prior to 2007.

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Tools4Patient: Starting a new year with 20/20 hindsight

January 29, 2020

As 2019 came to a close and we begin a new decade, it’s an excellent opportunity to evaluate and learn from the past year and set a course for the future. Tools4Patient (T4P) had a momentous year as we increased on our focus on the commercialization of Placebell©™ – T4P’s innovative approach to reduce the impact of the

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