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Rho-Supported Study Wins the David Sackett Trial of the Year Award from the Society for Clinical Trials

Published 06/06/16


For Immediate Release

Groundbreaking LEAP trial investigating peanut consumption awarded

Chapel Hill, NC  ̶  June 6, 2016  ̶  Rho, a full-service contract research organization (CRO) focused on bringing new products to market through a full range of product development services, was recently honored as part of the clinical trial team for the LEAP Trial: Randomized Trial of Peanut Consumption in Infants at Risk for Peanut Allergy. This groundbreaking National Institutes of Health (NIH) funded study was named the David Sackett Trial of the Year Award winner by the Society for Clinical Trials (SCT) on May 17, 2016, during the Society’s 37th Annual Meeting.  

The study, Learning Early About Peanut Allergy (LEAP) was supported by the National Institute of Allergy and Infectious Diseases (NIAID), part of the NIH, and conducted by researchers in NIAID’s Immune Tolerance Network (ITN). Lead by Gideon Lack, M.B., B.Ch., of King’s College London, the study tested the hypothesis that early introduction of peanut in the diets of children at risk for developing peanut allergy could lead to a reduction in peanut allergy at age five. The results from the study, published in the New England Journal of Medicine in 2015, found an overall 81 percent reduction of peanut allergy in children who began early, continuous consumption of peanut, compared to those who avoided peanut.

The David Sackett Trial of the Year Award is given annually to a randomized clinical trial that best fulfills the following standards: 

  • It improves the lot of humankind.
  • It provides the basis for a substantial, beneficial change in health care.
  • It reflects expertise in subject matter, excellence in methodology, and concern for study participants.
  • It overcomes obstacles in implementation.
  • The presentation of its design, execution, and results is a model of clarity and intellectual soundness.

“For many years, physicians had recommended that parents avoid giving infants and young children potentially allergenic foods, such as peanut,” said Michelle Sever, M.S.P.H., Ph.D., Senior Research Scientist/Co-Principal Investigator, Rho. “Yet the incidence of peanut allergy in children has doubled since 1997, leading researchers to question this guidance. The LEAP study has demonstrated that a careful introduction of peanut protein in the diet of infants is both safe and extremely effective at preventing potentially life-threatening peanut allergy in the children at highest risk.” 

As part of Rho’s federal market work, the company serves as the Statistical and Data Coordinating Center for the NIAID Immune Tolerance Network, supporting approximately 25 active clinical trials and related research studies on allergic diseases, lupus nephritis, multiple sclerosis, type 1 diabetes, transplantation and more. Rho provides support for statistical analysis, safety monitoring, data management, as well as supporting study protocol and manuscript development. 

Approximately 30 Rho employees have provided support for the LEAP study, including researcher Michelle Sever, M.S.P.H., Ph.D., who was a co-author of the published results. Rho also supported a follow-up to the study, which found that children who consumed peanut-containing foods regularly from infancy to age five and then avoided peanut for one year did not become allergic to peanut. This result strongly suggested that the benefit of early peanut consumption is long-lasting. The LEAP study and its follow-up, also published in the New England Journal of Medicine, were funded in part by the National Institute of Allergy and Infectious Diseases, part National Institutes of Health. 

This work was funded in part by NIAID under award numbers NO1-AI-15416, UM1AI109565 and HHSN272200800029C. Other organizations providing support include Food Allergy Research & Education, the Asthma UK Centre, and the UK Department of Health. The study results can be found on ITN Trialshare (www.itntrialshare.org) an open-access website that hosts studies conducted by the ITN. Additional details are available at ClinicalTrials.gov using the identifier NCT00329784 for LEAP and NCT01366846 for LEAP-On. 

To learn more about Rho, please visit www.rhoworld.com.

About Rho
Rho, a privately-held, contract research organization (CRO) located in Chapel Hill, NC, provides a full range of clinical research services across the entire drug development process. For more than 32 years, Rho has been a trusted partner to some of the industry’s leading pharmaceutical, biotechnology, and medical device companies as well as academic and government organizations. Our commitment to excellence, our innovative technologies, and our therapeutic expertise accelerate time to market, maximize returns on investment, and lead to an exceptional customer experience. Please follow us on Twitter.