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Network

Update on Site Selection Process: October 2019

We are delighted with the enthusiastic response from the SCD community to our request for proposals for CTN trial sites issued this fall. We received 26 applications representing roughly 50,000 patients with SCD across the U.S.

Inclusiveness and commitment to rigorous standards are the two guiding principles we believe set the SCD CTN apart from others and will ensure its success. Our goal is to include as many sites as can meet the requirements of participation. To that end, we provided each applicant site with feedback on their application, including an individualized roadmap for successfully completing the multi-step process, which includes a site visit and contribution of data to the Data Hub.

Sites will be onboarded into the network and announced on a rolling basis, once they have completed all the requirements. Please contact SCD-CTN@ashresearchcollaborative.org with questions.

About the Network

While there are currently only two U.S. Food and Drug Administration (FDA)-approved drugs to treat sickle cell disease (SCD), there is a robust SCD drug development pipeline poised to drive demand for SCD clinical trials to a new level, providing a prime opportunity to advance treatment and care of those affected by SCD.

At the same time, there are many challenges in conducting clinical trials for SCD, including a shortage of primary investigators, clinical trial sites, and enrolled patients; lack of access to a centralized data repository; poor coordination among sites; and flawed study designs. In addition, the voice of the patient has been largely absent in decisions about clinical trials in SCD, which has led to failures in patient enrollment and support. 

The ASH Research Collaborative (ASH RC) SCD Clinical Trials Network was launched with a mission of improving outcomes for individuals with SCD by expediting SCD therapy development and facilitating innovation in clinical trial research. It provides the infrastructure for identifying patient cohorts for trials, matching trial sponsors with sites, facilitating recruitment of eligible patients, and ensuring optimally designed trials and an efficient, coordinated approach. Through patient engagement and optimized clinical trial execution, the Network is helping to bring new and more effective therapies to individuals with SCD. 

The Network and its partners share a commitment to:

  • Forging new relationships with patients to increase their understanding of clinical trials and trust in SCD researchers
  • Eliminating inefficiencies through the use of a centralized data repository (the ASH RC Data Hub) and institutional review board
  • Focusing on the research opportunities that hold the most promise for patients.

The Network promotes quality, patient safety, and efficiency in SCD clinical trials by centralizing functions and sharing best practices. While traditional responsibilities for running a clinical trial remain with the participating sites and industry, the Network’s activities seek to address many of the common barriers faced in clinical trials research:

  • Patient engagement, education, and recruitment
  • Matching sponsors with trial sites
  • Ensuring an efficient coordinated approach to clinical trials research

Former ASH President Alexis Thompson, MD, MPH, hosted a Q&A session on the SCD CTN during the 60th ASH Annual Meeting in San Diego. View the video below to learn more.

For more questions regarding the Network, please view the FAQs or contact ASH RC CTN Staff at SCD-CTN@ashresearchcollaborative.org.