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Clinical Research and Infrastructure (CLIN)

Title: Clinical Research and Infrastructure
Title Code: CLIN

Purpose: The purpose of this supplement is to address research and infrastructure needs for clinical research in the NIDCD mission areas of hearing, balance, smell, taste, voice, speech, and language. For the purposes of this supplement, clinical research is defined as research on prevention, diagnosis, treatment, and/or rehabilitation of individuals with a communication disorder. Similarly, clinical epidemiologic research is epidemiologic research focused specifically upon patients.

Supplement-Specific Information: Research requests must be within the scope of the parent grant and may include, but are not limited to: adding new clinical sites to existing studies and clinical trials; adding a new class of patients to epidemiological studies; performing additional data analyses; interactions among collaborators and participants (e.g., industry, patient-advocacy organizations, and foundations); planning and development activities to generate ideas and design of follow-up trials and studies; the conduct of pilot studies; identifying and analyzing factors that influence variability and susceptibility to disease and response to treatment; assessing and refining intervention strategies; developing techniques to assess patient performance; understanding how the natural history of a disease/disorder can be used to deliver the most effective treatment; and encouraging participation in understudied clinical areas such as otopathology.

Infrastructure requests must be within the scope of the parent grant and should increase ease and efficiency in areas of clinical research that address communicative disorders. Infrastructure needs may include, but are not limited to: biomedical informatics and information technology support such as data collection and management tools, as well as electronic import and export of data; support for regulatory compliance and management; support for patient access and recruitment; development of disease nomenclature and data collection processes; informed consent and IRB issues; and biostatistical support. While the goal is to enhance the local environment supporting clinical research, supplement requests designed with a larger goal of sharing program outcomes with other institutions and providing infrastructure needs across groups of investigators or across a region are especially welcome. The supplements may bring together existing research groups studying one common disease area or may provide advances to be utilized by investigators studying several disease areas. This may involve using common consent forms, protocols, and data management processes; pooling resources and subjects across multiple sites; or moving research from a single-site to a multi-site approach. These activities should enhance existing capabilities and should allow participating institutions to develop and/or facilitate access to specialized resources and infrastructure support for clinical research.

This supplement applies only to activities addressing issues related to clinical research.

Supplement Contact and Email:
Contact the Program Officer for the currently funded grant, as indicated in your Commons account.