Dr.s Randi Hagerman and Norman Brule report on the Clinical Trials Program at the latest MIND Institute Research Seminar Series

MINDRSS_Oct23The bi-weekly MIND Institute Research Seminar Series continued on October 23 with a presentation by Dr.s Randi Hagerman and Norman Brule. Dr. Hagerman kicked off the presentation with a discussion of the importance of this program. Clinical trials at the MIND Institute typically consist of children with neurodevelopmental delays trying treatments, or clinicians looking for potential biomarkers. Though many clincial trials are drug trials, others include probiotics (Dr. Kathy Angkustsiri) and therapeutic video games (Dr.s Marjorie Solomon and Julie Schweitzer). Dr. Hagerman explained the importance of these trials as an interface between basic science and what the parents really care about — improvements in their kids.

The clinical trails program at the MIND facilitates all parts of the clinical trials process, including regulatory documents, budget negotiation, protocol visits, data entry, and ensures guidelines are followed. The hard work of the team resulted in a “squeaky clean” audit from the FDA, as well as AAHRPP certification, a very high standard in human research studies.

Dr. Hagerman additionally presented results from one of the studies. She indicated exciting results in improvements on visual perception, fine motor, and composite scores in children, however noted how difficult it is to pick outcome measures before beginning a trial.

Future directions for the team include a host of new and exciting trials, as well as incorporating outcome measures and interventions from other teams at the MIND Institute.

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