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Blog Post
Statistical Challenges with Site Enrollment in Clinical Trials
Did you know that insufficient enrollment is the leading cause for clinical trials being halted? Study sponsors rightly embrace those sites which are high performing as they give a study the best opportunity to meet its enrollment targets. However, is it possible for there to be overreliance on these high enrolling sites? Unfortunately, the answer is yes.
Blog Post
Marketing Application Reviews: Best Practices for Responding to Information Requests
Responding to information requests (IRs) from FDA during review of a marketing application can be stressful. How do you survive the rollercoaster of requests? We have outlined useful tips and best practices for managing responses to IRs during FDA review of your marketing application.
Blog Post
Overcoming statistical challenges in rare disease drug development
Regulatory agencies like the FDA require substantial evidence of the drug’s effectiveness for its intended use and sufficient information to conclude that the drug is safe. However, flexibility is given in how the standard can be met given the challenges associated with the limited number of subjects available in rare disease.
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?
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.
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?