Serving as the Statistical and Data Coordinating Center for the NIAID (NIH’s National Institute of Allergy and Infectious Diseases) Immune Tolerance Network, Rho provides support for statistical analysis, safety monitoring, data management, as well as supporting study protocol and manuscript development for approximately 25 active clinical trials and related studies on allergic diseases, lupus nephritis, multiple sclerosis, type 1 diabetes, transplantation and more.
Rho research scientist Michelle Sever told Outsourcing-Pharma.com that the center also offers “pharmacovigilance; preparation of study related materials including data safety monitoring board reports, periodic study management reports, clinical study reports, and manuscripts; posting to clinicaltrials.gov; preparation and documentation of clinical data shared publically; and clinical study web site development and maintenance.”
Rho’s contract with NIH runs through June 15.
Published in the New England Journal of Medicine, the study, called Learning Early About Peanut Allergy (LEAP), found that the early introduction of peanuts significantly decreased the frequency of the development of peanut allergy among children at high risk.
The study was supported by the NIAID and conducted by researchers in NIAID’s Immune Tolerance Network, as well as about 30 Rho employees.
“While it’s too soon to recommend stepping up peanut consumption among all babies, the findings provide striking new insights into how food allergies develop and how they might be avoided,” NIH Director Francis Collins said in a blog post.
Rho said it will continue to support the next phase of the study, which hopes to determine whether the reduction in peanut allergy among those in the peanut-consuming group will be maintained if they avoid eating peanuts for a year.
“Food allergies, particularly peanut allergy, which is the most common cause of life-threatening food-induced anaphylaxis, are a growing concern around the world,” said Herman Mitchell, Ph.D., VP and senior research scientist, Rho. “For many years, physicians recommended that young children avoid peanut in their diet to reduce developing peanut allergy. Yet peanut allergy doubled in the decade following 1997 and therefore the American Academy of Pediatrics rescinded this recommendation in 2008. Dr. Lack’s study suggests that not only is avoidance likely to be unhelpful, but rather early introduction of peanut in the diet of the children helps to prevent later peanut allergy.”
This work was funded in part by NIAID, as well as Food Allergy Research & Education, the Asthma UK Centre, and the UK Department of Health.