DURHAM, NC - May 15, 2019 - For Immediate Release

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

The Scleroderma: Cyclophosphamide or Transplantation (SCOT) trial awarded

Research Triangle Park, NC  ̶  May 14, 2019  ̶  Rho, a full-service contract research organization (CRO) focused on bringing new products to market through a full range of product development services, announced today that the Scleroderma: Cyclophosphamide or Transplantation (SCOT) trial is the recipient of the prestigious David Sackett Trial of the Year Award, presented annually by the Society for Clinical Trials (SCT). Dr. Lynette Keyes-Elstein, principal statistical scientist at Rho will accept the award on behalf of the SCOT trial team. She will present the SCOT trial on May 20, 2019, at the Society’s 40th Annual Meeting in New Orleans, Louisiana. This is the second time Rho has been supporting a study that has been honored by SCT.

Scleroderma (also known as systemic sclerosis) with internal organ involvement is a progressive, clinically heterogeneous autoimmune disease characterized by skin thickening and fibrosis of internal organs. Of the more than 100 autoimmune diseases, it is one of the most devastating as it is resistant to treatment and associated with considerable morbidity and mortality.

In the SCOT trial, adults with severe scleroderma were randomly assigned to undergo myeloablative autologous hematopoietic stem-cell transplantation (AHCT) or to receive cyclophosphamide. The primary analysis led to conclusive findings favoring myeloablative AHCT. SCOT is the first long-running randomized trial to use myeloablation with AHCT in comparison to cyclophosphamide. Rates of treatment-related deaths and post-transplant use of Disease-modifying antirheumatic drugs (DMARDs) with the SCOT myeloablative regimen were lower than those reported for non-myeloablative transplant regimens 2,3.

For the first time, improved long-term survival free of use of DMARDs was demonstrated in a devastating autoimmune disease. The American Society for Blood and Marrow Transplantation Task Force now recommends AHCT as the standard of care for patients with severe disease.

Each year since 2008, the SCT has awarded the David Sackett Trial of the Year Award to a randomized, controlled trial published in the previous calendar year that best fulfills the following standards:

• Improves the lot of humankind;
• Provides the basis for a substantial, beneficial change in health care;
• Reflects expertise in subject matter, excellence in methodology, and concern for study participants;
• Overcomes obstacles in implementation; and
• Based on the presentation of its design, execution, and results is a model of clarity and intellectual soundness.

Nominations are submitted by Society members, investigators, and interested scholars from around the world. The 2018 Trial of the Year selection committee included Marc Buyse, Henry Bob Dworkin, Susan Ellenberg, Scott Evans (Chair), Dean Follmann, Toshimitsu Hamasaki, Frank Rockhold, Dan Rubin, and Yves Rosenberg. 

The SCOT trial was supported by the National Institute of Allergy and infectious Diseases of the National Institutes of Health.

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

About Rho

Rho, a privately-held, contract research organization (CRO) located in Research Triangle Park, NC, provides a full range of clinical research services across the entire drug development process. For more than 35 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 Facebook, LinkedIn and Twitter.

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