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Embracing Human Complexity in Clinical Research
As clinical trials become more diverse, patient heterogeneity, placebo responses, and inter-site variability become more pronounced, contributing to high rates of failed trials and extended development timelines…
The Placebo response in drug development Part 3: Parkinson’s disease
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…
The Impact of COVID-19 on Clinical Trial Conduct: The Importance of Considering Patient Stress, Coping and Perceptions
Learn the importance of considering patient psychological traits, expectations, perception of patient relationship with the trial physician and staff, and social structure in efforts to understand the impact of the COVID-19 pandemic on clinical trials.
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…
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…
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…
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…
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