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Notice of Information: NICHD to issue a Research Opportunity Announcement to support Advancing Cures and Therapies and ending ENDOmetriosis diagnostic delays - ACT ENDO (OTA Clinical Trial Optional)

National Institutes of Health

The purpose of this Notice is to alert the community that NIH plans to publish a Research Opportunity Announcement (ROA) to invite applications from eligible organizations to engage with NICHD to develop, advance, and/or validate new devices, biomarkers, and/or methods or repurpose existing devices for non-invasive diagnosis of endometriosis. The ROA will consist of two stages: 1) An open call for pre-applications from applicants with an interest in submitting an application to “Advancing Cures and Therapies and ending ENDOmetriosis diagnostic delays (ACT ENDO)”; and 2) An invitation-only stage to apply to the “Advancing Cures and Therapies and ending ENDOmetriosis diagnostic delays (ACT ENDO)” Research Opportunity Announcement to be offered in summer of 2024.

No awards will be made in response to the Stage 1 preapplication step, but Stage 1 participation is required to receive an invitation to Stage 2. An award under Stage 2 will be issued as an Other Transactions Agreement (OTA), which is not a grant, contract, or cooperative agreement. OTAs will involve active NIH program management.

Increased research is urgently required to improve our understanding of endometriosis initiation, progression, and pathophysiology as a path toward non-invasive diagnostics, improved treatments, and, ultimately, prevention and cure. Projects supported by the ACT ENDO initiative will aim to shorten the time to diagnosis, decrease the invasiveness of current techniques, and/or improve accessibility, safety, convenience, and costs of diagnosis. These projects will also encourage collaborations with investigators and entities who have not yet applied their expertise to gynecologic research, thereby expanding the potential scientific insight and investigational toolkit available to these projects. It is anticipated that, through rigorous collaborative R&D efforts, safe and effective techniques, instruments, and devices can be developed for use in the evaluation and diagnosis of people with endometriosis.

The tools and technologies developed with funding through this ROA are expected to be integrated systems or, if they are novel components, to be easily integrated into existing systems. Some other technical features that are expected are the following: reliability, accuracy, precision, robustness, safety, simplicity, reliance on the appropriate baseline information, contextual awareness, and inclusion of software to support decision-making where appropriate. Proposed tools and technologies should incorporate existing standards and consider regulatory requirements where appropriate. In addition, improved access to underserved areas, and cost-effectiveness should be highlighted.

For the purpose of this ROA, non-invasive procedures will be defined as “procedures that do not require incision, [non-blood] medical tissue removal, or contact with a bodily orifice beyond natural orifices.” For example, venipuncture, finger pricks, analysis of menstrual effluent, and transvaginal imaging modalities will be considered responsive to this ROA, but endometrial biopsies will be considered “invasive” and therefore non-responsive.

Applications are not being solicited at this time.

NOT-HD-24-016

Specialties

Medical

Medical - Clinical Science

Medical - Basic Science

Medical - Translational

Eligibility Requirements

Sponsor Details

Sponsor Institute/Organizations: National Institutes of Health

Sponsor Type:

Address: National Institutes of Health; 31 Center Drive; MSC 2220; Bethesda; MD 20892-2220; USA

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