Effects of NIH Clinical Trials Policy Changes on NIDCD-Funded Research
The NIDCD is committed to building and expanding our clinical trials program to promote the development of therapies and interventions to treat and prevent communication and other disorders in our core mission areas: hearing, balance, taste, smell, voice, speech, and language. The NIDCD has a longstanding history of funding basic science research in these areas and encourages the translation of basic science discoveries to therapies that benefit patients through the conduct of clinical trials and other patient-oriented research.
We recognize that the body of work necessary to fully develop an intervention—especially a new intervention—is an extensive, long-term endeavor. Support is needed at every step, from basic science discovery to early-stage translational research, culminating in clinical trials to establish safety and efficacy of the intervention, as well as late-stage translational research to optimize proven interventions and develop treatment guidelines and strategies to disseminate the intervention into widespread clinical practice.
Clinical trials supported by the NIDCD must align with current NIH policy and meet high standards of scientific rigor in both how the study is designed and how it is carried out. The safety of volunteer participants is the highest priority.
The NIDCD has redefined the scope of R01 and U01 clinical trials applications to correlate with risk in terms of safety, complexity, fiscal investment, and direct scientific/public health impact:
- Lower risk: NIDCD clinical trials applications determined to have low risk will use the R01 funding mechanism through the NIDCD Low Risk Clinical Trials in Communication Disorders (R01 - Clinical Trial Required) program announcement (PAR-21-063).
- Higher risk: NIDCD clinical trials applications determined to have higher risk will use the U01 funding mechanism through the NIDCD Cooperative Agreement for Clinical Trials in Communication Disorders (U01 - Clinical Trial Required) program announcement (PAR-21-064). The cooperative agreement U01 mechanism continues to be the most appropriate mechanism for higher-risk clinical trials as these will benefit from the substantial scientific and programmatic involvement of an NIDCD Project Scientist. This approach aligns with NIH efforts to enhance stewardship over clinical trials.
For applicants: If you are planning to submit an NIDCD intervention study/clinical trial application on or after January 25, 2018, you will need to select the appropriate funding opportunity to be sure that you comply with all relevant regulations and policies and include the required information for peer review. Some of the new requirements include new forms, implementation of the NIH single institutional review board (IRB) policy, training in Good Clinical Practice (GCP), and registration on ClinicalTrials.gov. (See Clinical Trial Requirements for NIH Grants and Contracts.)
For currently funded NIDCD researchers: The upcoming changes are unlikely to affect currently funded projects but may affect your competing continuation. Many projects not previously identified or designated as clinical trials may be reclassified as clinical trials upon renewal. Please note that NIH policies for Good Clinical Practice (GCP) training and ClinicalTrials.gov registration have been in effect since January 2017.
The NIH Guide to Grants and Contracts will be regularly updated for funding opportunity publications and announcements related to clinical trials. We anticipate that most NIDCD lower-risk applications previously reviewed by the Center for Scientific Review (CSR) will continue to be reviewed in that venue; NIDCD Phase III, higher-risk interventions, and/or more costly applications will be reviewed by the NIDCD Scientific Review Branch.
The NIDCD believes that our clinical research and even some of our basic research will benefit from the required elements (starting January 25, 2018) in the grant application and award process. We are working together to ensure that our important clinical research continues and thrives.
NIDCD staff are available to help you through this transition. The NIDCD Clinical Trials Program Medical Officers can answer your questions and work with you to determine whether your proposed study is a clinical trial; find the appropriate funding mechanism for your application; and prepare the appropriate clinical trial required documents.
Written questions or requests for telephone consultation may be submitted to Trinh Ly, M.D.