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Blog Post

Where did the odds ratios go?

Reviewing recent FDA approvals, you may be struck by the total absence of odds ratios. Browsing the labels from the 2023 novel approvals, you can find proportions, differences in proportions, Chi-Squared analyses, CMH and variants, but logistic regression and odds ratios have practically disappeared from labeling. What gives?

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Blog Post

FDA’s Benefit-Risk Framework for NDAs and BLAs: The Presentation

FDA’s Benefit-Risk Framework is the presentation for communicating the assessment of the benefits and risks based on the therapeutic context, available evidence and uncertainties for the product in development.

News

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.

News

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.

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Webinar

Engaging a CRO? Ask Sites What They Think First

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.

Are you asking them for it?

Rho_Resource_Blog
Blog Post

Study-Size Adjusted Percentages in Integrated Adverse Event Displays

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.

News

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.

News

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.

Rho_Resource_Blog
Blog Post

Submitting SAS Programs to FDA

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.