LuMind IDSC and the Down Syndrome Clinical Trials Network are pleased to announce the launch of the DS-CTN Data and Safety Monitoring Board (DSMB). This service was created to provide accurate Down syndrome expertise to sponsored clinical trial protocols enrolling individuals with Down syndrome.

The DSMB is 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.

By matching the needs of each clinical trial to the specific field of expertise a team will monitor the progress of a clinical trial, review safety and effectiveness data during the length of the project, and will provide independent, non-biased recommendations and reviews.

DSMB Teams will enhance the safety, oversight, and integrity of any clinical trial where individuals with Down syndrome are involved and 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 and have the ability to see the data from a neutral and unblinded point of view. 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.

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.

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).