Clinical Development
Breathing New Insights: Exploring the Dynamic Connection Between Lung Function, Allergy and Wheezing in Urban Children
Cindy Visness, PhD, Rho’s Principal Research Scientist, worked with investigators on the NIAID-funded Urban Environment and Childhood Asthma (URECA) study to dissect the complex web of factors influencing respiratory health in city-living children in the article, “Relationships between lung function, allergy, and wheezing in urban children” available in The Journal of Allergy and Clinical Immunology April edition.
Tips to Rescue a Clinical Trial Before It’s Too Late
Sometimes relationships can continue even when things aren’t working out. However, when it comes to the partnership between a sponsor and its contract research organization (CRO), there isn’t any time to waste. Failing to address issues quickly during a clinical trial can cause issues.
Unlocking sleep’s role in PTSD
Ben Vaughn, Rho’s Chief Strategist, Biostatistics & Protocol Design, supports Tonix Pharmaceutical’s analyses of how sleep disturbances impact posttraumatic stress disorder (PTSD). Their research sheds light on a novel treatment, TNX-102 SL, which targets sleep quality and emotional memory processing.
Understanding GDPR Compliance in Clinical Trials
Dive into the complexities of GDPR compliance in clinical trials in Contract Pharma’s article, Understanding GDPR Compliance in Clinical Trials, an interview with Laura Gatavs, Head of Legal Department for Rho EU. Explore the nuances of when and where GDPR applies, grasp the basics of compliance – both at company compliance level and when negotiating clinical trial agreements – and uncover essential takeaways and best practices for clinical trial sponsors.
Transformation in Trials: Becky Baggett on the Science and Strategy Behind Successful Clinical Trials
Tune in to hear Becky Baggett, Rho’s Associate Vice President of Project Delivery, navigate the world of clinical trials by “unraveling the complexities and enlightening us on the crucial collaboration between the sponsor and the CRO, the importance of clinical research sites, data management, and project management. She underscores the absolute necessity of establishing solid relationships, trust, and experience in this highly controlled and regulated field.”
‘Tis the Season: Shedding Light on Seasonal Affective Disorder
Seasonal affective disorder (SAD), also known as major depressive disorder with a seasonal pattern, is a condition of regularly recurring depressive episodes that most commonly occur in autumn and winter and remit during spring and summer. Despite the relatively high prevalence and morbidity of SAD, this disorder still often goes undiagnosed, in large part because health care professionals do not generally consider a potential seasonal pattern in a patient who presents with depression.
Drug Development & Estimands – A Framework that Evolves with Product Knowledge
Since the introduction of estimands, the answer to “Why are estimands necessary?” has remained constant – to allow for clearer communication about benefits/risks of a potential treatment to the relevant stakeholders. However, as illustrated in this blog, the number of questions as to how & when to use them has grown considerably.
The Benefits and Risks of Subgroup Analysis for an Overall Survival Endpoint
Analyses conducted using the overall population can mask the extent of the benefit-risk in subgroups of patients. Thus, subgroup analyses are critical to fully understand the benefit-risk in pivotal oncology trials and guide regulatory decisions for approval and labelling. However, subgroup analyses also present several challenges especially for overall survival (OS) where larger sample sizes and longer follow-up are needed, and where early analyses of immature data may be conducted.