All individuals had been pre-assigned to one of four discussion groups focusing on differing areas of research pertinent to translational research in hearing and balance (Molecular Diagnostic/Therapeutics, Bridging Basic Science to Clinical Science, Clinical Studies, Introduction and Emergence into Clinical Practice). Pre-meeting discussion among participants was encouraged. On the first day of the workshop, in conjunction with several invited NIH speakers, each of the 4 groups presented issues and discussion that had emerged from the pre-meeting teleconferences. On the second day, each group then presented research needs and opportunities for action. The agenda with links to presentations from both the first and second days can be found at the website above.
The workshop began with an introductory presentation by Amy Donahue, Ph.D. The history, organization, definitions and scientific portfolio coding strategy used for the purpose of the workshop was provided. Dr. Donahue also provided some overview information on the NIH Roadmap. Thomas Miller, Ph.D., from the National Institute on Neurological Disease and Stroke (NINDS), and Bruce Cuthbert, Ph.D., National Institute on Mental Health (NIMH), presented translational research programs for which they are responsible within their own NIH Institute. Jochen Schacht, Ph.D. presented a case history of translational research experiences and obstacles as related to aminoglycoside-induced HL and antioxidants.
Following this introductory session, the panel on Molecular Diagnostic/Therapeutics presented their considered issues and ideas, followed by the panel on Bridging Basic Science to Clinical Science. After lunch, Katherine Woodbury Harris, Ph.D., presented information on a NIDCD preliminary clinical studies program. Presentations from the panel on Clinical Studies and the panel on Introduction and Emergence into Clinical Practice ended the first day. Each panel reconvened in the evening for additional discussion and formulation of recommendations.
On the second morning, Katherine Zoon, Ph.D. National Cancer Institute presented on FDA requirements necessary to move from a newly identified molecule to human testing. Each of the four panels then presented their recommendations/suggested actions, during which there was considerable and active group discussion.
Overall goal: Capitalize on the uniqueness of NIDCD (i.e. many of our disorders are preventable) to develop a model for the creation of an evidence based medicine rationale for TR. To achieve this goal: Establish stepwise developmental milestones for TR, thus providing both guidelines for, as well as a mechanism to demonstrate, forward progress/success (to be conducted in a sequential or parallel manner depending on relative state of development): epidemiological studies, development of animal models, studies of molecular mechanisms, pharmacokinetics and pathophysiology, and conduct of clinical studies.
Support a Framingham-type epidemiological study (or fund add-on outcome measures to an existing/planned study) to specifically address sensory disorders (natural history, prevalence, treatment effectiveness, disease parameters).
Support the establishment of an NIH-based Clinical Trials Center (e.g. TR Center) that is open to all institutes to review existing ‘basic’ and pre-clinical data in consultation with PIs, identify missing or gaps in data needed for progression to clinic, develop necessary investigation device documents, provide resources for good manufacturing practices product development, and to provide design for and conduct all needed clinical trials.
Support mechanisms to disseminate/communicate positive results of trials conducted by the Clinical Trials Center or any other clinical recommendations.
NIDCD should take a leadership position in mobilizing the public community/ developing public awareness of sensory disorders as a public health issue as a mechanism to provide much-needed patient advocacy in support of initial and continuing TR initiatives (toxic noise, presbyacusis, vaccines for otitis media, aminoglycoside-induced ototoxicity).
Continue to support goal-oriented ‘basic’ TR initiatives via the issuance of an RFA/PAR with a focus on the following areas of research related to sensory disorders (e.g. systems for delivery of substances to the inner and middle ear, pharmacology (toxicity), pharmacokinetics, pathophysiology). [This recommendation is not intended to exclude/subvert the R01 process but rather serve as an adjunct to this mechanism; goal could perhaps also be achieved via rapidly-reviewed ‘TR supplements” to existing R01s].
Panel 2: Bridging Basic Science to Clinical Science, Joe Miller, Ph.D. (Chair)
Define TR: The creation of new technologies (broadly defined) from basic research discoveries to improve health care and quality of life, including clinical and outcome research.
Create new and effective funding mechanisms for TR (especially the early phase) with special review committee (e.g., R21, R24, R01 (or P50); R03, R01; SBIR from phase 1 to phase 2).
Establish review criteria and mechanism for identifying promising TR with high potential socio-economic and health benefits’.
Disseminate information about funding and merits of TR (PAs, RFAs, RFPs, workshops (i.e., ARO)).
Based upon the identification of promising basic science, encourage basic research (BR) scientists to engage in TR and interdisciplinary collaborative research (including multi-institutional) activities.
Encourage academia-industrial collaboration/partnership (invite industry input into TR mechanism that would encourage participation and cost sharing).
Educate Center for Scientific Review (CSR), study section members and academic leaders in the importance of TR.
Continue to build regional core facilities (P30).
Continue mentoring awards for young faculty (e.g., specific TR training, facilitate transition into TR project).
Collaborate with other institutions to develop comprehensive epidemiological data base in hearing/balance disorders.
Maintain a healthy level of funding for BR; minimize direct competition between BR and TR (varying opinions on whether there should be a special allocation for TR vs. no special allocation for TR).
Panel 3: Clinical Studies, Bruce Gantz, M.D. (Chair)
Invigorate the Clinical Research Initiative.
Clinical Research Planning Grant Mechanism with NIDCD Review.
Multi-institutional Clinical Research Infrastructure Grants with NIDCD Review
Develop Clinical Research Supplement for RO1.
Foster the development of a Clinical Research Data Base that could be used across institutions.
Homogenize Regulatory Mechanisms across institutions.
Develop practice-based research networks.
Promote translational research using mechanism that rewards clinical research-basic science research collaboration.
Increase the number of qualified clinical investigators (MD and PhD Audiologists, PhD’s in other disciplines).
Make it more attractive for young faculty to enter clinical research (i.e., use training (T) and career development (K) mechanisms to promote Clinical Research Track; provide a transition period of support following completion of K).
Support Shadow Programs (e.g., basic scientist would spend a short period of time in a clinical setting and a clinician scientist would spend a short period of time in a basic science setting).
Identify successful clinical clinician/scientist and develop programs to teach mentoring.
Create an Advisory Committee of experienced clinicians to advise NIDCD on clinical studies/trial development (could formulate relevant clinical questions, suggest RFA’s for new clinical trials, and study and make recommendations for expanded NIDCD clinical research focus- Develop Strategic Plan).
Encourage the NIDCD to have an expanded workshop devoted to clinical research and clinical trials.
Panel 4: Emergence into Clinical Practice, Mary Pat Moeller, Ph.D. (Chair)
Increase NIDCD’s role in the dissemination of research evidence (i.e., promote systematic reviews of evidence, and identify evidence needs in priority areas).
Foster collaborations with related agencies focused on outcomes/dissemination.
Increase evidence-based training opportunities (mentorship, cross-disciplinary study, promoting the use of evidence-based medicine tools).
Develop reporting standards (MOOSE, CONSORT) to improve the usefulness of published data to guide science and policymakers.
Promote the use of participatory research methods (i.e., alignments with advocacy groups, and technical support from experienced R25s).
Identify and re-evaluate priority areas, selecting outcomes with broad health impact.
Sponsor conferences with TR focus (should be cross-disciplinary and include communication research).
Define the ideal role/components of TR Centers.
Continue to support the NIDCD dissemination function.
Continue to support research in health communication.
Continue to support efforts in epidemiology.
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