Insights
Pandemic Stress Will Affect Clinical Trial Response: What Can Industry Do?
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.
The placebo response in drug development. Part 2: Osteoarthritis
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).
Are clinical trials patients’ reactions to crisis related to their personality? Application to the COVID-19 pandemic.
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.
Data Integrity in GCP environment
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.
The Placebo response in drug development. Part 1: Rheumatoid Arthritis
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.
The Opioid Crisis in the US: Fueling the Next Wave of Drug Development for Chronic Pain
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.