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Data and Safety Monitoring Board (DSMB)

The goal of the DSMB is to provide accurate Down syndrome expertise to sponsored clinical trial protocols enrolling individuals with Down syndrome. As leaders in the Down syndrome research field, the LuMind IDSC Down Syndrome Clinical Trial Network offers DSMB service to any academic, industry, or government organization. The composition, design, and delivery of each DSMB are standardized with ICH and FDA guidelines.

Spearheaded by a committee of independent clinical research experts who are also physicians, statisticians, academic and clinical experts, Down syndrome field leaders, and patient advocates.

Our Role:

Match the needs of each clinical trial to the specific field of expertise.

Monitor the progress of a clinical trial by a team of Down syndrome experts.

Review safety and effectiveness data during the length of the project.

Provide independent, non-biased recommendations and reviews.

Why does the Down Syndrome DSMB matter for your research?

  • The purpose of the DSMB is to enhance the safety, oversight, and integrity of any clinical trial where individuals with Down syndrome are involved. Our experts are tasked with monitoring patient safety and drug efficacy. The ultimate role is to protect the Down syndrome participants, making sure they are not at risk for harm.
  • This service will strengthen the scientific integrity of the study because DSMB members take a third-party stance during a clinical trial
  • With this external perspective, they can better understand emerging treatment effects, whether they might be good or bad, as the study is underway. The DSMB is essential to ensure an unbiased review of trial data.

The Data and Safety Monitoring Board is currently convened for the LIFE-DSR-BIO study, which uses a research-only tracer in PET imaging and collects biomarker data in 220 people with Down syndrome (blood, spinal fluid, brain).

As leaders in the Down syndrome research field, the LuMind IDSC Down Syndrome Clinical Trial Network strives to ensure individuals with Down syndrome are provided the opportunity to participate in clinical trials while always putting the safety and well-being of the community first. Because of this mission, we find it critical to offer DSMB service that as experts and community members that understand the conditions and diseases common in Down syndrome.  Our position in the Down syndrome field allows us to do this by bringing together a committee of independent clinical research experts who are also physicians, statisticians, academic and clinical experts, Down syndrome field leaders, and patient advocates.

The LuMind IDSC DSMB

  • Is available to any academic, industry or government organization.
  • Strives to provide accurate Down syndrome expertise to sponsored clinical trial protocols enrolling individuals with Down syndrome.
  • Composition, design, and delivery of each committee is curated to the specific needs of the protocol/biologic/device being studied.
  • Is standardized with ICH and FDA guidelines.

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