Cincinnati, OH ~ September 10, 2015- CTI Clinical Trial and Consulting Services (CTI), a multi-national, privately held, full-service contract research organization announces it recently collaborated with the Tuberous Sclerosis Alliance to analyze a Natural History Database of currently more than 1,700 people with tuberous sclerosis complex (TSC).
In 2006, the Tuberous Sclerosis Alliance, in partnership with a network of TSC Clinics, launched the TSC Natural History Database, the first-of-its-kind project to collect information about TSC, which affects various organs in the human body including the brain, heart, kidneys, lungs, liver, skin and eyes. TSC is also associated with developmental disorders such as autism. Written permission is obtained from an individual with TSC (or from the parent of a child or dependent adult with TSC) to enter clinical information from his or her medical record into the TSC Natural History Database, which is a web-based system. New clinical information is added to the database as it is documented in the individual’s medical record.
The analysis, performed by CTI and the Tuberous Sclerosis Alliance, was designed to compare various manifestations between genotypes and to determine if correlations exist between TSC symptoms and the TSC gene mutation. Data will be presented comparing various characteristics between TSC1 and TSC2 genotypes at the International TSC Research Conference: From Treatment to Prevention in Windsor, United Kingdom, taking place September 10-12, 2015. William Irish, PhD, Vice President, Biostatistics and Health Outcomes Research at CTI and one of the abstract’s authors, will make the presentation.
“We’re finding that groups like the Tuberous Sclerosis Alliance are becoming increasingly more important in drug development and research in rare diseases, as there is often a lack of information on rare disorders in published literature or traditional databases,” according to Joseph McCafferty, Vice President, North American Sales. “CTI is at the forefront in advancing these kind of collaborations and research efforts. We are very pleased to assist the Tuberous Sclerosis Alliance advance their mission to find a cure for tuberous sclerosis complex while improving the lives of those affected.”
“We are extremely proud to partner with CTI on presenting this important analysis on data collected in the TSC Natural History Database since 2006. For individuals and families who have participated in this important study, we are hopeful this type of information will help lead to scientific breakthroughs, ultimately improving the quality of life for those struggling with the daily challenges of TSC,” shared Kari Luther Rosbeck, President and CEO of the Tuberous Sclerosis Alliance.
Unifying Industry to Better Understand GCP Guidance
May 7th 2025In this episode of the Applied Clinical Trials Podcast, David Nickerson, head of clinical quality management at EMD Serono; and Arlene Lee, director of product management, data quality & risk management solutions at Medidata, discuss the newest ICH E6(R3) GCP guidelines as well as how TransCelerate and ACRO have partnered to help stakeholders better acclimate to these guidelines.
Full Phase IIIb BATURA Trial Results Show Airsupra Cuts Severe Exacerbations by 47% in Mild Asthma
May 20th 2025Results from the pivotal BATURA trial show that Airsupra (albuterol/budesonide) significantly outperformed albuterol monotherapy in reducing severe asthma exacerbations and systemic corticosteroid exposure, reinforcing its role as a next-generation, anti-inflammatory rescue therapy for mild asthma patients.