Com3705 assign1 info

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Com3705 assign1 info

Full Text of Announcement Section I. Funding Opportunity Description Purpose This Funding Opportunity Announcement FOA supports applications from Small Business Concerns SBCs for exploratory clinical trials that contribute to the justification for a future trial to establish definitive efficacy such as a Phase 3 clinical trial or a pivotal device trial.

This includes Phase 1 and 2 clinical studies of drugs, biologics and biotechnology products, feasibility studies of devices, as well as preliminary clinical studies of surgical, behavioral or rehabilitation therapies. A wide range of trials at different stages of development are allowed, including first-in-human as defined by the Food and Drug AdministrationPhase 1 and 2 single-site clinical studies, and Phase 2b multicenter clinical studies.

Applications should aim to generate data that inform further clinical development of the proposed intervention. The earliest studies should be designed to provide important initial information regarding the intervention e.

This FOA is not intended to support the conduct of a clinical trial where the primary aim is to establish or confirm definitive efficacy pivotal trials. Traditionally, large pharmaceutical and biotechnology companies, as well as venture capital firms, have provided the resources needed to conduct the clinical studies required to fully develop and commercialize biomedical products and technologies.

More recently, however, many investors in life science technologies have shown a preference toward financing the continued development of relatively mature technologies at established companies, rather than the higher-risk, emerging technologies under development at many small businesses.

As a result, many small businesses need to have clinical data to attract sufficient third-party investment. Definitions For this funding opportunity announcement, Phase 1 and 2 clinical studies or trials refer to the common phases of a clinical trial.

Evaluate and optimize the dose, formulation, safety, tolerability, usability, acceptability or pharmacokinetics of an intervention in healthy volunteers or the target population. Evaluate whether an intervention produces sufficient evidence of short-term activity e.

Select or rank the best of two or more potential therapeutic approaches or dosing regimens to be evaluated in a subsequent trial, based on tolerability, biological activity, or preliminary clinical efficacy. NIDDK recognizes that devices can differ greatly in terms of basic form and function, physiological bases for therapy, degree of invasiveness, etc.

A pivotal device study, for example, could potentially be used in support of a new indication of an existing market approved device, or to provide evidence for a novel device design in support of a Pre-Market Approval PMAHumanitarian Device Exemption HDEk or k De Novo submission.

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NIDDK will prioritize applications to develop novel interventions and discourages submission of applications to develop "me-too" strategies. NIDDK will also prioritize applications to develop interventions for indications for which there are no or few effective therapies or prevention strategies.

Applicants should take note of the following: A trial will not be considered for funding under this FOA when its primary objective is to estimate intervention effect size to be used in power calculations for a future efficacy clinical trial. Effect size estimates based on small or short-term studies are often unreliable.

The MCID is the smallest change in a treatment outcome that a patient would identify as important; it is often determined by surveying patients or their physicians.

Com3705 assign1 info

For drugs and biologics, issues of study feasibility and refinement of study procedures may be addressed as secondary aims in an exploratory clinical trial, but not as the primary aim. Examples of such secondary aims include: Collecting information on the utility of questionnaires, rating scales, or biomarkers Developing and refining standardized methods of assessing outcome Optimizing methods for identifying, recruiting, and retaining study participants Creating clinical trial infrastructure 3 Multiple Trials: There may be multiple questions remaining to be answered before a Phase 3 trial can be designed and conducted.NIH Funding Opportunities and Notices in the NIH Guide for Grants and Contracts: NIDDK Exploratory Clinical Trials for Small Business (R44) PAR NIDDK Department of .


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