The DS-CTN team offers a suite of study/trial support services. Each package is customized to the sponsor’s/investigator’s needs:
PROTOCOL REVIEW COMMITTEE (PRC) SERVICES
The DS-CTN PRC provides access to Down syndrome experts representing a broad range of scientific expertise. The PRC facilitates high quality clinical trial design and implementation through their knowledge of Down syndrome. This is a required activity for all clinical trials using the DS-CTN sites.
DOWN SYNDROME-RELATED FOCUS GROUPS
The DS-CTN offers customizable focus groups and community meetings to get qualitative data and perspectives from individuals with DS and/or their care providers. Focus groups are convened to review a protocol’s schedule of events, consent forms, and participant-facing materials.
DEVELOPING PARTICIPANT FACING RESOURCES
The DS-CTN provides clinical trial collateral customized to engage and inform participants with DS and their caregivers. Suite of materials can include: explainers for the informed consent process, engagement in and explanation of trial activities through social stories, handouts, and informational videos.
CLINICAL TRIAL CONTRACTING (CTA)
The DS-CTN can facilitate CTA review and execution between the sponsor and DS-CTN sites. Studies have identified the CTA process as one of the top 3 contributors to trial delay which we aim to minimize through our network membership.
TRAINING ON CLINICAL ASSESSMENTS
The DS-CTN provides a training platform to provide quality, standardized training specific to DS. This training curriculum is the first of its kind, singularly focused on patient- and caregiver-reported assessment scales used to measure cognitive and behavioral function in individuals with DS.
SUPPORT SERVICES FOR PARTICIPANTS
The DS-CTN strives to ensure every trial experience is a positive one for participating families. Direct-to-patient services provide support and cover costs for study visit logistics, as travel is a major contributor to a study participant’s decision to participate and their overall study experience. This is a required activity for all clinical trials utilizing the DS-CTN sites.
DATA SAFETY MONITORING BOARD (DSMB) SERVICES
The DS-CTN DSMB provide an established board, with customizable expertise available, to ensure adequate safety oversight and reliability of your clinical trial data. Biostatistical and data management support can be included or provided by the Sponsor/CRO.
SITE MANAGEMENT, FEASIBILITY & SITE SELECTION
The DS-CTN understands site selection is the keystone to a successful clinical trial. The DS-CTN project management team ensure the identification of qualified Investigators and site teams who are trained to conduct your study adhering to GCP and ICH guidelines, regulatory requirements, and Down syndrome specific challenges.
The DS-CTN data management arm provides data services and efficient communication, leveraging our experience in Down syndrome and dementia GCDMP and regulatory guidelines to streamline and meet your timelines.
Other services can be added as necessary for project success, including: Consultation on Down syndrome outcome measures, assessment scales, study design, and clinical trial materials. These can be developed per project, or per sponsor to cover multiple projects.
*Protocol Review Committee and Crisis Plan services are required activities for every study/trial requesting conduct through the LuMind IDSC DS-CTN. Consent/Assent language development support highly recommended, in light of the unique community we represent.