# CORE FUNCTION ACTIVITIES - NICHD CCTN STATISTICAL AND CLINICAL COORDINATING CENTER

> **NIH NIH N01** · HEALTH DECISIONS, INC. · 2021 · $583,953

## Abstract

There is a demand for new methods of contraception that can provide effective protection against
unintended pregnancy. The Eunice Kennedy Shriver National Institute of Child Health and
Human Development (NICHD)’ s Contraceptive Clinical Trials Network (CCTN) is to develop
protocols and conduct clinical trials that will assist in product development with the end goal to
provide effective and safe contraception for women and men.
The goal of the NICHD's CCTN is to systematically evaluate the safety and efficacy of new or
existing female and male contraceptive drugs and devices as well as treatments of selected
gynecologic conditions in Phase I, II, III and IV clinical trials conducted under Good Clinical
Practices guidelines. The results of these clinical trials on new entities would be the basis for
advancing candidate drugs and devices through clinical development with the ultimate goal of
submission to the FDA in support of an Investigational New Drug (IND) application and
initiation of New Drug Application (NDA) for a new drug for male or female contraception; and
for a device, Premarket notification 510K, Premarket approval (PMA), and Investigation Device
Exemption (IDE).

SCOPE
To provide statistical, clinical coordinating support and services to the CCTN and NICHD for a
variety of tasks related to the development and conduct of clinical trials of male and female
contraceptive products under Good Clinical Practices guidelines, as well as to provide if
necessary ancillary services for the trials, such as product formulation, packaging, distribution,
insurance and stability testing. Additional services supporting clinical evaluation and regulatory
approval of candidate entities will be provided as needed for individual products.

## Key facts

- **NIH application ID:** 10329867
- **Project number:** 75N94019D00004-P00003-759401900125-1
- **Recipient organization:** HEALTH DECISIONS, INC.
- **Principal Investigator:** CLINT DART
- **Activity code:** N01 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2021
- **Award amount:** $583,953
- **Award type:** —
- **Project period:** 2019-09-20 → 2021-09-19

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10329867

## Citation

> US National Institutes of Health, RePORTER application 10329867, CORE FUNCTION ACTIVITIES - NICHD CCTN STATISTICAL AND CLINICAL COORDINATING CENTER (75N94019D00004-P00003-759401900125-1). Retrieved via AI Analytics 2026-05-23 from https://api.ai-analytics.org/grant/nih/10329867. Licensed CC0.

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