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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.

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.

Study sites have a tremendous influence on how, when, and where clinical trials take place. They’re the ones training personnel, allocating staff, enrolling participants, managing paperwork, and so much more. So it makes sense that when sponsors need to make important decisions—like which CRO to choose—sites will most certainly have an opinion.

To those of us who regularly create or review adverse event (AE) incidence tables for randomized controlled trials, it may come as a surprise that your typical AE incidence table can be misleading if data was combined from more than one trial. This is due to “Simpson’s paradox,” which, simply put, is the phenomenon that the mere grouping of data can introduce confounding or bias otherwise not present.

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.

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.

Biometrics teams can generate hundreds, if not thousands, of SAS programs throughout the drug development process. So how do you know which ones to submit to the FDA? And how do you go about submitting the programs?

As statisticians, we’re frequently asked to do power and sample size calculations from very thin data. Often, we’re given nothing but an ancient publication containing a few p-values, an occasional mean, and maybe a standard deviation (if we’re lucky). Back calculating something meaningful in these situations can seem intimidating, but it turns out that most standard sample size software can do the work for us when used unconventionally. We’ve outlined 2 such unconventional uses.

Innovation in early-stage studies presents the best opportunity to streamline the drug development process. Such designs may not only reduce costs and accelerate timelines but give us better flexibility to address the questions of interest in an increasingly evolving clinical development landscape.