To support IDDRC investigators in translational research planning, and implementation throughout the drug discovery pipeline, from preclinical to phase 2 clinical trials, including regulatory guidance, biostatistical support, recruitment of participants and controls, as well as biological sample and data distribution. Other resources available will include preclinical consultation for drug discovery efforts and training opportunities.
The Clinical Research and Regulatory Affairs Service offers consultative services to investigators in designing human studies, including the preparation of IRB and FDA submissions. Staff will provide project management services including assistance with study staff supervision, study monitoring and audit preparation. Additionally, the Service can facilitate access for IDDRC investigators to the Research Participant Registry (RPR), a recruitment registry of >21,500 individuals (children and adults) with typical and atypical development who are interested in research participation, as well as to a human neurobehavioral assessment core for phenotyping efforts.
The Data Analysis Component provides biostatistical support during the planning phase of new clinical research projects, providing assistance with study design and power calculations. As projects progress, Kush Kapur, PhD, Senior Biostatistician at BCH and Assistant Professor of Neurology at Harvard Medical School, will provide assistance with data analysis and statistical hypothesis testing. For larger scale projects, further biostatistical support is available through the Clinical Research Program of Boston Children’s Hospital. As needed, highly specialized biostatistical support is available to IDDRC investigators from the Harvard Clinical and Translational Research Center (Harvard Catalyst) for projects with complex study design.
Preclinical Consultation Services are administered by Robin Kleiman, PhD who was recruited to Boston Children’s Hospital from industry to provide drug discovery expertise to investigators building preclinical therapeutic programs for neuroscience related disorders. Dr. Kleiman advises investigators on strategies for target identification and validation, screening funnel and biomarker development or study design of preclinical drug trials. Dr. Kleiman can provide critical review of drug discovery grant applications to funding agencies or industry partners and advice for working with industry.
The Bio-repository was originally established for the Department of Neurology in 2008 by Elizabeth Engle, MD to better understand causes and develop new therapies for neurological disorders. The collection has expanded to include blood samples, saliva, CSF, urine, skin punch and post-surgical brain tissue with collaborations across multiple departments. The goal is to spur future research by fellows and other researchers at BCH on already collected biological samples with phenotypic data for de-identified use in translational research and clinical trials
- To request core services, contact the TNC: firstname.lastname@example.org