Department of Health
and Human Services (HHS)
and Human Services (HHS)
RESCINDED
NOT-DC-22-002 - Notice of Informational Webinar for PAR-21-063 and PAR-21-064: Planning to Consult with the Clinical and Translational Science Award (CTSA) Trial Innovation Network (TIN)
National Institute on Deafness and Other Communication Disorders (NIDCD)
National Center for Advancing Translational Sciences (NCATS)
This Notice invites clinical investigators planning to submit applications in response to PAR-21-063 - NIDCD Low Risk Clinical Trials in Communication Disorders (R01 Clinical Trial Required) or PAR-21-064 - NIDCD Cooperative Agreement for Clinical Trials in Communication Disorders (U01 - Clinical Trial Required) to request consultation with the NCATS CTSA Trial Innovation Network (TIN) prior to their planned submission date. The purpose of this collaboration between NIDCD and the NCATS CTSA Program is to allow NIDCD applicants utilization of the built clinical trials infrastructure, resources and services available through the TIN which it is hoped will enhance the likelihood of success of NIDCD supported mulit-site clinicalt trials (CTs). Expected advantages to applicants include improved quality and robustness of CT applications, timely trial implementation and completion of the trial on schedule and within the specified budget whil successfully meeting the specific aims of the project.
Applicants who seek input regarding all relevant aspects of their proposed clinical research study including Data Coordinating Center (DCC) support are advised to consult the TIN up to 6 months in advance of their planned submission datesto provide adequate time to receive design and statistical support and to prepare the application. Applicant seeking selected resources with standard agreements and budget require less advanced time. Please see this area on the TIN website: https://trialinnovationnetwork.org/elements/trial-innovation-network-proposal-process/.
Participation in this Notice is optional for all applicants but will enable a comparative scientific assessment of the value of specific TIN resources and services to NIDCD-funded investigators and thereby inform strategies for future clinical trial support.
Background
The National Institute on Deafness and Other Communication Disorders (NIDCD) supports clincial research to advance the science of communication in its mission areas of hearing, balance, taste, smell, voice, speech and language and is committed to identifying effective interventions for the diagnosis, prevention and treatement of communication disorders by supporting well-designed and well-executed clinical trials.
To improve the likelihood that its supported clinical trials will meet this high standard and to reduce the likelihood of delays, inefficiencies, redundancy or overlap NIDCD is inviting its applicants to seek consultation with the NCATS Clincial and Translational Science Awards (CTSA) Trial Innovation Network (TIN) prior to their planned submission date. For comprehensive consultations that will result in an application involving one of the TIN awardees as the data coordinating center a lead time of up ot 6 months prior to the planned submission date is highly encouraged. Less time is needed if selected TIN resources are requested. Pre-submission consultation may include guidance relevant to protocol development, statistical considerations, trial budgeting, regulatory agreements including single IRB (sIRB), data-driven site selection and feasability assessment, and recruitment and retention planning. Successful applicants whose projects are selected for NIDCD funding are encouraged to continue consultative interations with the CTSA TIN in areas such as start-up, clincial trial operations enhancement, data coordination and management, data safety and monitoring, quality assurance, etc., to the extent these resources and services are relevant to the proposed study.
NIDCD plans to make available a recorded pre-application webinar to provide information and respond to questions from prospective applicants to PAR-21-063 or PAR-21-064. The webinar will be posted on the NIDCD website and will be linked to FAQs and other helpful application resources. No comments on specific ideas or plans for individual research applicaitons will be provided during the webinar. Please see NOT-DC-22-002 for additional details.
Application and Submission Information
This Notice applies to due dates on or after February 5, 2022 for the following FOAs:
PAR-21-063 - NIDCD Low Risk Clinical Trials in Communication Disorders (R01 Clinical Trial Required)
PAR-21-064 - NIDCD Cooperative Agreement for Clinical Trials in Communication Disorders (U01-Clinical Trial Required)
Mary Purucker, MD, PhD
National Institute on Deafness and Other Communication Disorders (NIDCD)
Division of Scientific Programs (DSP)
Telephone: 240-285-8793
Email: puruckerm@mail.nih.gov