The long-term hope is that the A1BC cohort can be used for many downstream studies. To that end, the executive committee encourages ancillary studies.
Ancillary studies take many forms:
- 1) Proposals to determine the feasibility of a larger grant can be discussed with any of the A1BC investigators. These opportunities need not have independent funding, but will require a short study proposal that teams with one of the A1BC centers to ask novel questions that can be answered quickly with existing data.
- 2) The Alpha-1 Foundation has pilot and feasibility grants for junior investigators. Grant opportunities are listed here. (link to pilot awards on A1F). Similar grants are available from the Chest Foundation partnership with the A1F and with the ATS partner grants programs. Discussion with the A1BC team to partner with letters of support is encouraged.
- 3) The NIH has determined that the A1BC grant is qualifying for a notice of special interest (NOSI) for ancillary studies to large ongoing clinical studies. The application process is described here: https://grants.nih.gov/grants/guide/notice-files/NOT-HL-21-030.html
Ancillary studies under this mechanism are competitive across the NHLBI portfolio and might:
- Identify additional and/or unique/emerging risk factors for the disease(s) of interest to NHLBI
- Delineate pathogenic mechanisms of disease
- Identify mechanisms or factors that influence and/or predict response to treatment
- Discover or validate biomarkers of disease development and/or progression
- Identify or characterize co-morbid illnesses associated with the disease(s) of interest to NHLBI
- Describe the natural history and risk factors for an additional disease(s) – i.e., different than the focus of the parent grant
- Identify sex and/or gender differences that effect symptom recognition, diagnostic strategies, adverse events and efficacy of therapy
Specific research examples include, but are not limited to:
- Understand the contributions of factors such as sex, race, ethnicity, and social determinants of health to variations in risk for HLBS disorders
- Characterize the trajectory of the decline and contribution of individual modifiable risk factors to HBLS across lifespan, such as in maternal pre- and post-natal environment, adolescent, and mid-life
- Elucidate risk factors and markers of pathobiology in women associated with increased susceptibility and severity of HLBS
Following are the Ancillary Study policies forms and guidelines for the Alpha-1 Biomarkers Consortium: