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Enhancing the stewardship and scientific rigor of clinical trials, and an update on NIDCD’s May advisory council meeting

June 6, 2024

Four health professionals reviewing x-rays.

Clinical trials are at the heart of all advances in medical care. They involve prospectively assigning human participants to one or more interventions to evaluate the impact on health-related biomedical or behavioral outcomes. Findings from NIDCD clinical trials help to advance new approaches to preventing, diagnosing, and treating disorders of hearing, balance, taste, smell, voice, speech, and language that affect millions of people in the United States.

In this director’s message, I outline NIDCD’s efforts to align with NIH stewardship policies for clinical trials, which aim to ensure that studies are well-designed and include valid endpoints so that findings are relevant, accurate, and timely. I describe tools to help applicants write successful grant applications for clinical trials, as well as resources available to grantees whose projects are funded. I also summarize topics discussed at the May meeting of the National Deafness and Other Communication Disorders Advisory Council.

Stewardship of Clinical Trials

In 2017, NIH implemented policy updates to enhance its stewardship of clinical trials. These updates improved the design, efficiency, and timely reporting of clinical trials by strengthening processes across study life cycles, including the approaches to funding opportunities, information collected in the applications, grant review criteria, post-award monitoring and oversight, and research sharing and dissemination.

To align with NIH’s stewardship policies, NIDCD redefined the scope of its R01 and U01 clinical trials applications using a risk-based approach. Risks for NIDCD clinical trials are evaluated based on safety, complexity, fiscal investment, and direct scientific/public health impact. The U01 cooperative agreement mechanism is used for higher risk clinical trials that would benefit from substantial post-award scientific and programmatic involvement from an NIDCD scientist. Higher risk trials could include studies that have greater safety risks to participants, require FDA oversight, are defined as Phase III trials, or incur annual direct costs of $700,000 or more. Lower risk trials, which are intended to gather scientific data to inform subsequent studies, do not have these risks and are funded under the R01 mechanism. More information about additional requirements for U01 applications can be found on our website.

Tools to Support Clinical Trial Grantees Pre- to Post-Application

Under these U01 and R01 funding mechanisms, NIDCD currently supports a broad spectrum of clinical trials across all of the institute’s mission areas. Our portfolio encompasses research to advance innovative drug, dietary, device, behavioral, and other interventions for both children and adults.

All clinical trial applications submitted to NIDCD should align with current NIH policy, be fiscally responsible, and meet high standards of scientific rigor in study design, implementation, and maintenance. To ensure that these standards are clear to applicants and grantees, NIDCD’s online resources help applicants navigate the clinical trials grant application and review process. Our website provides guidance on choosing the appropriate funding opportunity, budget considerations, review criteria specific for clinical trial applications, data and safety monitoring guidelines, and other resources.

NIDCD also provides post-award guidance to assist grantees with effective administration of their clinical trials. Our website explains steps prior to implementing NIDCD U01 clinical trials to ensure safety, integrity, and quality; training in principles of Good Clinical Practice (GCP); protocol development; and guidance on registering the study with NIDCD is also exploring ways to assist our research teams conducting high-risk U01 clinical trials, and to provide tools to assist the NIDCD clinical trials research community with project management, clinical trial implementation readiness, and quality management efforts.

If you are a scientist or clinician working in our mission areas, I encourage you to explore the comprehensive list of NIDCD resources for pre- and post-award clinical trials.

National Deafness and Other Communication Disorders Advisory Council Meeting, May 16

On May 16, the institute’s advisory council convened at the National Institutes of Health in Bethesda, Maryland. Portions of our council meetings are open to the public, and I invite you to watch the archived videocast of the May 16 open session. I also encourage you to join us online for our next meeting, to be held September 12-13, 2024. A few highlights from May’s meeting are summarized below.

  • I provided some high-level updates on extramural workforce diversity by comparing NIDCD’s data with averages across all of NIH. For fiscal years 2015–2023, NIDCD generally had slightly lower percentages of underrepresented minority (URM) grantees. However, R01 grant award success rates were higher for our URM grantees, which was partly due to NIDCD’s prioritization of funds for R01 mechanisms. I then provided an overview of NIDCD’s programs focused on diversity, equity, inclusion, and accessibility (DEIA) and our participation in NIH-wide DEIA initiatives. To view this segment, start at the 00:12:23 mark of the videocast.
  • I also described an NIH Common Fund research opportunity announcement that seeks applications focused on developing a primary care infrastructure that facilitates clinical research efforts and healthcare delivery, primarily in underserved communities. The deadline to apply for this opportunity is June 14. To view this segment, start at the 00:21:32 mark of the videocast.
  • Joni L. Rutter, Ph.D., Director of NIH’s National Center for Advancing Translational Sciences (NCATS), outlined efforts to address bottlenecks in the translational pipeline and described several collaborations between NCATS and NIDCD, including the Rare Diseases Clinical Research Network, the Tackling Acquisition of Language in Kids initiative, and a Phase II clinical study to prevent aminoglycoside-induced ototoxicity. To view this segment, start at the 00:24:00 mark of the videocast.
  • Trinh Ly, M.D., NIDCD Medical Officer, described the roles of the institute’s clinical trials support team: to provide consultation and guidance to extramural teams, manage clinical trial operations, and provide technical expertise and oversight for higher risk clinical trials. She also provided additional information on the R01 and U01 clinical trial funding options. To view this segment, start at the 01:18:24 mark of the videocast.
  • Jaclyn Schurman, Au.D., Ph.D., Extramural Research Training Officer for Fellowship Programs, provided an update on NIDCD fellowship application success rates and announced a June 26 webinar for those interested in applying for NIDCD’s individual fellowship program. To view this segment, start at the 1:53:54 mark of the videocast.
  • Alberto Rivera-Rentas, Ph.D., Extramural Research Training Officer in NIDCD’s Division of Scientific Programs, provided an update on the institute’s R25 mentoring and research training programs. To view this segment, start at the 01:59:54 mark of the videocast. Four grantees then described their NIDCD-supported projects under these programs:
    • Lauren Calandruccio, Ph.D., Professor in the Department of Psychological Sciences at Case Western Reserve University, described the Innovative Mentoring through Professional Advancement and Cultural Training (IMPACT) program for underrepresented minority undergraduate students interested in communication sciences and disorders. To view this segment, start at the 02:07:55 mark of the videocast.
    • Rochelle Newman, Ph.D., Professor in the Department of Hearing and Speech Services at the University of Maryland, described the Research, Equity, and Access in Communication and Hearing (REACH) program for underrepresented undergraduate students interested in communication science and related fields. To view this segment, start at the 02:20:58 mark of the videocast.
    • Jay Piccirillo, M.D., FACS, Professor in the Department of Otolaryngology–Head & Neck Surgery at Washington University School of Medicine in St. Louis, described the university’s Physician-Scientist Training Program for medical residents. To view this segment, start at the 02:38:50 mark of the videocast.
    • John S. Oghalai, M.D., Professor in the Department of Otolaryngology–Head and Neck Surgery at the University of Southern California’s Keck School of Medicine, described the university’s Clinician-Scientist Training Program. To view this segment, start at the 02:55:34 mark of the videocast.
  • One of the newest council members, Daniel Merfeld, Ph.D., Professor in the Department of Otolaryngology–Head and Neck Surgery at the Ohio State University College of Medicine, described his work exploring the vestibular system’s role in visual stability, balance, spatial orientation, and autonomic processes. To view this segment, start at the 03:13:44 mark of the videocast.
  • Becky Wagenaar-Miller, Ph.D., Director of NIDCD’s Division of Extramural Activities, announced several updates, including an FDA-NIH request for information on a new resource for terminology in clinical research that closes June 24; increases in National Research Service Award stipends; changes in application and review of grants due on or after January 25, 2025; and an upcoming simplified peer review process for NIH fellowship applications. She also noted that NIDCD seeks peer reviewers for grant submissions. To view this segment, start at the 03:37:23 mark of the videocast.
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