RFA-AA-18-005: Alcoholic Hepatitis Clinical and Translational Network – Clinical Pilot Trials (U01)
Internal Deadline: Contact the Office of Research if interested.
LOI: September 23, 2017, 5pm PDT
External Deadline: October 23, 2017, 5pm PDT
Award Information: Type: Cooperative Agreement
Estimated Number of Awards: 9
Anticipated Amount: $675,000
Submission Process: PIs must submit their application as a Limited Submission through the Office of Research Application Portal: https://app.wizehive.com/webform/USCgrants
Materials to submit:
- Single Page Proposal Summary (0.5” margins; single-spaced; font type: Arial, Helvetica, or Georgia typeface; font size: 11 pt). Page limit includes references and illustrations. Pages that exceed the 1-page limit will be excluded from review.
- CV – (5 pages maximum)
Who May Serve as PI: Standard NIH eligibility requirements.
Through this FOA, applications are sought to conduct investigator-initiated single-center feasibility and pilot studies to optimize critical elements for full-scale clinical trials including agent(s), dosing, enrollment and adherence, data collection and appropriate outcome and follow-up. The overall objectives of these studies are to generate sufficient data for 1) informing “go/no-go” decisions about further testing of the candidate interventions and 2) optimization of the design of the late-stage clinical trials for obtaining meaningful results.
The clinical component consists of up to 9 collaborative U01 clinical centers conducting common multi-center clinical phase 2b trials and observational studies in patients with AH; some of these centers will also conduct the U01 Clinical Pilot Trials of intervention-development related issues.
To meet these objectives, projects should address the core clinical trial design issues, including the feasibility, tolerability, acceptability, safety, and preliminary indications of effectiveness of therapeutic interventions. The pilot studies are expected to involve a small number of patients and will not achieve statistical significance, but may lead to new clinical trial design to increase the success rates of drug efficacy studies. Despite their outcomes, the pilot studies will provide information of high utility to the field by informing decisions about whether further testing is warranted and by filling gaps in scientific knowledge. Both novel investigational drugs and rescued or repurposed drugs are appropriate for this announcement.
Some examples of research topics appropriate for this FOA include, but are not limited to:
- Evaluating and optimizing the dose, formulation, safety, tolerability of an intervention in the target population;
- Assessing pharmacokinetics of the studied agents and establishing relationships between the dose, schedule, exposure and effect;
- Evaluating the feasibility of recruitment, retention, assessments, and reporting of adverse events;
- Identifying inclusion and exclusion criteria to be applied in phase 2b and above clinical trials;
- Developing and refining data collection procedures;
- Determining the best methods for identifying, stratifying, and recruiting study subjects;
- Obtaining sufficient evidence of short-term improvement in patients to justify an efficacy trial;
- Evaluating strategies for recruitment and retention to overcome logistical barriers and disparities in clinical trial participation among racial/ethnic minorities, socioeconomic and other diverse populations.
This FOA may support activities related to the conduct of the pilot studies, including, but not limited to:
- Regulatory activities to support the implementation of the trial;
- Training of study personnel related to the conduct of the trial;
- Enrollment and recruitment of study participants;
- Data collection, management, and quality control for the trial;
- Laboratory work and data analysis;
- Study management and oversight;
- Other related post-enrollment activities;
- Preparation of the final study report.
Visit our Institutionally Limited Submission webpage for updates and other announcements.