Following the completion of designated milestones in the clinical trial planning process, investigators may consider applying for a Clinical Trial Implementation Cooperative Agreement (U01). The NIAMS will only accept, peer review, and consider funding applications for implementation of investigator-initiated clinical trials when the necessary planning and administrative tasks have been completed. Normally applications to the NIAMS go through a two-part process, which begins with an R34 planning grant (Part 1) followed by an application for the U01 (Part 2). Investigators who have completed all necessary pre-trial planning and preparation through other means may apply for a NIAMS U01 without having applied for an R34. Clinical trials must also meet all applicable NIAMS, NIH, Food and Drug Administration (FDA), and Office of Human Research Protections (OHRP) policy requirements. Review the FDA Good Clinical Practice guidelines for more information. Read the full PAR-18-594 funding announcement.
Purpose
A U01 clinical trial implementation cooperative agreement application should describe all necessary components to successfully conduct a trial. Implementation support is defined as support for activities related to the conduct of the clinical trial, including, but not limited to:
- Training of study personnel.
- Enrollment and recruitment of study subjects, including women, racial and ethnic minorities, children, and other special populations, as appropriate.
- Data collection, management and quality control.
- Laboratory work and data analyses.
- Study management and oversight.
- Establishment of committees to manage the complexity of the trial.
- Preparation of the final study report.
- Other related post-enrollment activities.
Resources to support clinical trials during clinical trial implementation can be obtained from the NIAMS program staff. Refer to the NIAMS clinical trials policies and guidelines for more information.
Research Area Examples
Examples of studies that might be supported by this Funding Opportunity Announcement include, but are not limited to:
- Clinical trials focusing on the prevention or treatment of a rheumatic, musculoskeletal or skin disease or disorder.
- Clinical trials to investigate safety, efficacy, or effectiveness of novel therapeutic approaches for one or more of these conditions.
- Clinical trials testing methods to increase preventive health behaviors for one or more of these conditions.
Clinical trials testing methods to increase preventive health behaviors for one or more of these conditions. Each NIAMS Clinical Trial Implementation U01 award will support the implementation of a single clinical trial. Applications that include more than one clinical trial will not be reviewed.