Opportunity Information: Apply for RFA HL 14 005
Apply for RFA HL 14 005
- The National Institutes of Health in the health sector is offering a public funding opportunity titled "Comparison of Strategies to Study Pediatric Pulmonary Vascular Disease Outcomes Using Bioinformatics (U01)" and is now available to receive applicants.
- Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 93.838 Lung Diseases Research.
- This funding opportunity was created on Jun 1, 2012 and posted on Jun 1, 2012.
- Applicants must submit their applications by Feb 21, 2013. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
- The funding agency has allocated a total of $1,800,000.00 to eligible and selected applicants.
- Each selected applicant is eligible to receive up to $1,800,000.00 in funding.
- Eligible applicants include: Small businesses Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education Special district governments State governments Others (see text field entitled Additional Information on Eligibility for clarification) Independent school districts Public and State controlled institutions of higher education Private institutions of higher education For profit organizations other than small businesses County governments Native American tribal governments (Federally recognized) Native American tribal organizations (other than Federally recognized tribal governments) Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education Public housing authorities/Indian housing authorities City or township governments.
- Other Eligible Applicants include the following Alaska Native and Native Hawaiian Serving Institutions Eligible Agencies of the Federal Government Faith based or Community based Organizations Hispanic serving Institutions Historically Black Colleges and Universities (HBCUs) Indian/Native American Tribal Governments (Other than Federally Recognized) Non domestic (non U.S.) Entities (Foreign Organizations) Regional Organizations Tribally Controlled Colleges and Universities (TCCUs) U.S. Territory or Possession.
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Opportunity Summary:
This NHLBI funding opportunity (RFA HL 14-005) supports a single cooperative agreement award (U01) to establish and run a Bioinformatics Clinical Coordinating Center (BCCC) focused on pediatric pulmonary vascular disease (PVD). The central purpose is to directly compare how well two different prospective data sources can answer important clinical and translational questions in a rare, heterogeneous pediatric condition: (1) electronic health record (EHR)-derived data and (2) traditional prospective patient-based clinical and research data collected in a more conventional study format. By building and evaluating both approaches side by side, the project aims to clarify the real-world strengths, limitations, and biases of each method for understanding disease natural history, tracking longitudinal outcomes over time, and identifying phenotypes of therapeutic response in children treated for PVD.
The practical problem the FOA is trying to solve is that pediatric PVD is uncommon, varies widely across patients, and is managed across multiple institutions, which makes it difficult to assemble large, consistent datasets that can answer outcome and treatment-response questions with confidence. Traditional prospective research cohorts can capture detailed, standardized variables but are expensive, slow to scale, and often limited in sample size. EHR data can be broader and more reflective of routine clinical practice, but it can be messy, incomplete, inconsistently coded, and dependent on local documentation habits. NHLBI is essentially asking applicants to treat this as a head-to-head evaluation: design two prospective data-collection pipelines, use them to address the same pediatric PVD research questions, and then rigorously compare what each pipeline can and cannot support.
Applications are expected to lay out, in detail, the methods, operational plans, and expertise needed to develop both data sources. On the EHR side, this generally implies capabilities such as multi-site data harmonization, phenotype definition, structured and unstructured data extraction, coding and terminology mapping, data quality assessment, and approaches to missingness and confounding that are common in real-world clinical data. On the traditional prospective research side, the expectation is a plan for standardized variable definitions, consistent follow-up schedules, adjudication of key outcomes where appropriate, and research-grade capture of clinical characteristics and therapies. Because the award is for a coordinating center, the FOA also emphasizes multi-institutional coordination and multidisciplinary staffing, bringing together bioinformatics and computational expertise with clinicians who have direct access to pediatric PVD populations.
A core required element is that applicants propose at least three specific pediatric PVD research questions that both data strategies could address. While the FOA does not prescribe the exact questions, they must be relevant to (a) natural history (how the disease evolves over time), (b) longitudinal outcomes (clinical trajectories, morbidity, mortality, utilization, functional status, etc.), and (c) phenotypes of therapeutic response (identifying which patient subgroups respond differently to specific treatments). The intent is not only to see whether the data sources can produce an answer, but also to compare the credibility, completeness, timeliness, and generalizability of those answers when derived from EHR data versus traditional research data.
Another major expectation is a clear, defensible comparison framework for evaluating the usefulness of the two data sources. In practice, this means proposing measurable criteria and analytic approaches to assess data fitness-for-purpose, such as completeness of key variables, accuracy/validity of case definitions, consistency of outcome capture, ability to measure exposures and timing (start/stop of therapies, dose changes, escalation), longitudinal continuity across encounters, sensitivity to site-to-site coding differences, and the impact of confounding and missing data on inference. The comparison should illuminate where EHR-based approaches can reliably answer real-world clinical management questions, where traditional prospective research collection remains necessary, and how the two might be combined or optimized to improve study efficiency and trial readiness.
The longer-term goal is explicitly practical: improve health outcomes for children with PVD and strengthen future clinical trial design. By demonstrating what EHR data can contribute (and where it falls short), the project is meant to inform better outcome measurement, better identification of clinically meaningful subgroups, and more efficient approaches to cohort assembly and follow-up. If EHR-derived methods prove robust for certain endpoints or phenotypes, they could reduce cost and time for future observational studies and potentially support more pragmatic trial strategies.
Administratively, this is an NIH discretionary funding opportunity administered by the National Institutes of Health, with NHLBI as the sponsoring institute, and it falls under CFDA 93.838 (Lung Diseases Research). It does not require cost sharing or matching. The FOA was posted June 1, 2012, with an original and current closing date of February 21, 2013, and an archive date of March 24, 2013. The estimated total funding and award ceiling are both listed as $1.8 million, consistent with making a single award to one coordinating center.
Eligibility is broad and includes public and private institutions of higher education, nonprofit organizations (including 501(c)(3) and certain non-501(c)(3) nonprofits), small businesses, other for-profit organizations (excluding small businesses under the separate small business category), and various government entities (state, county, city/township, special district governments, and eligible federal agencies). The FOA also notes additional eligible applicants such as minority-serving institutions (including HBCUs, Hispanic-serving institutions, Alaska Native and Native Hawaiian-serving institutions, and tribally controlled colleges and universities), faith-based or community-based organizations, U.S. territories or possessions, and non-U.S. entities/foreign organizations, among others. The emphasis, however, is not simply on institutional eligibility but on having the real capacity to coordinate a multi-site pediatric PVD effort and execute both the informatics-heavy EHR strategy and the more controlled traditional prospective strategy in parallel.
In summary, this U01 opportunity funds one BCCC to build and test two prospective data-collection approaches for pediatric PVD, use them to address at least three well-defined research questions about disease course and treatment response, and then produce a rigorous, transparent comparison of how EHR-derived data performs relative to traditional prospective research data. The expected deliverable is not just a dataset, but evidence-based guidance on when and how EHR data can be trusted for pediatric PVD outcomes research, and how that knowledge can be used to improve care and streamline future studies and trials.
Frequently Asked Questions (FAQs)
What is this funding opportunity?
This is an NHLBI (NIH) funding opportunity (RFA HL 14-005) to support a single cooperative agreement award (U01) to establish and operate a Bioinformatics Clinical Coordinating Center (BCCC) focused on pediatric pulmonary vascular disease (PVD).
Who is the sponsoring agency and what program area does it fall under?
The sponsoring institute is the National Heart, Lung, and Blood Institute (NHLBI) within the National Institutes of Health (NIH). The opportunity falls under CFDA 93.838 (Lung Diseases Research).
What is the main purpose of the project?
The central purpose is to directly compare how well two different prospective data sources can answer important clinical and translational questions in pediatric PVD: (1) electronic health record (EHR)-derived data and (2) traditional prospective patient-based clinical and research data collected in a conventional study format.
Why is NHLBI funding a head-to-head comparison of EHR data versus traditional prospective research data?
Pediatric PVD is rare, heterogeneous, and managed across multiple institutions, which makes it hard to assemble large, consistent datasets. Traditional prospective cohorts can be detailed and standardized but are expensive, slow, and often small. EHR data can be broader and reflect routine practice, but it can be incomplete, inconsistently coded, and dependent on local documentation habits. This FOA asks applicants to build both pipelines in parallel and compare their real-world strengths, limitations, and biases.
What does BCCC stand for, and what is it expected to do?
BCCC stands for Bioinformatics Clinical Coordinating Center. It is expected to coordinate a multi-institutional pediatric PVD effort, develop and operate both prospective data-collection approaches (EHR-derived and traditional prospective research collection), and implement a rigorous comparison framework to evaluate how well each approach supports pediatric PVD outcomes research.
How many awards will be made under this FOA?
The FOA is intended to support a single award to one coordinating center.
What is the award mechanism?
The funding mechanism is a cooperative agreement (U01).
What is the total estimated funding and award ceiling?
The estimated total funding and the award ceiling are both listed as $1.8 million, consistent with making a single award.
Is cost sharing or matching required?
No. The FOA states that cost sharing/matching is not required.
When was the FOA posted and when did it close?
The FOA was posted on June 1, 2012. The original and current closing date is February 21, 2013. The archive date is March 24, 2013.
What two data strategies must applicants build and evaluate?
Applicants are expected to design and implement two prospective data-collection pipelines:
- EHR-derived data pipeline (prospective use of EHR data across sites)
- Traditional prospective patient-based clinical and research data pipeline (research-grade, standardized collection in a conventional study format)
What kinds of capabilities are expected on the EHR-derived data side?
The FOA anticipates informatics-heavy capabilities such as multi-site data harmonization, phenotype definition, structured and unstructured data extraction, coding and terminology mapping, data quality assessment, and approaches to missingness and confounding common in real-world clinical data.
What kinds of capabilities are expected on the traditional prospective research data side?
The FOA anticipates a plan for standardized variable definitions, consistent follow-up schedules, adjudication of key outcomes where appropriate, and research-grade capture of clinical characteristics and therapies.
What is the required research-question component?
A required element is that applicants propose at least three specific pediatric PVD research questions that both data strategies could address.
What topics must the proposed research questions cover?
The proposed questions must be relevant to:
- Natural history (how pediatric PVD evolves over time)
- Longitudinal outcomes (clinical trajectories over time, such as morbidity, mortality, utilization, functional status, etc.)
- Phenotypes of therapeutic response (which patient subgroups respond differently to specific treatments)
Does the FOA specify the exact research questions applicants must use?
No. The FOA does not prescribe the exact questions, but it requires at least three well-defined questions that both data strategies can address and that align with natural history, longitudinal outcomes, and therapeutic response phenotypes.
What is meant by a "comparison framework" in this FOA?
The FOA expects a clear, defensible framework with measurable criteria and analytic approaches for evaluating the usefulness and fitness-for-purpose of EHR-derived data versus traditional prospective research data when answering the same pediatric PVD questions.
What kinds of criteria are expected in the comparison framework?
Examples described in the FOA include evaluating completeness of key variables, accuracy/validity of case definitions, consistency of outcome capture, ability to measure exposures and timing (including therapy start/stop, dose changes, escalation), longitudinal continuity across encounters, sensitivity to site-to-site coding differences, and the impact of confounding and missing data on inference.
What is the practical deliverable expected from the project?
The expected deliverable is not only data resources, but evidence-based guidance on when and how EHR-derived data can be trusted for pediatric PVD outcomes research, where it falls short relative to traditional prospective research collection, and how approaches might be combined or optimized to improve study efficiency and trial readiness.
How does the FOA connect to improving care and future clinical trials?
The longer-term goal is to improve health outcomes for children with PVD and strengthen future clinical trial design by clarifying which endpoints, phenotypes, and outcome measurements can be reliably supported with EHR-derived methods and which require traditional prospective research collection.
Why does the FOA emphasize multi-institutional coordination and multidisciplinary staffing?
The award is for a coordinating center and pediatric PVD is managed across multiple institutions. The FOA emphasizes coordinating multi-site participation and staffing that bridges bioinformatics/computational expertise with clinicians who have direct access to pediatric PVD populations.
What types of organizations are eligible to apply?
Eligibility is broad and includes public and private institutions of higher education; nonprofit organizations (including 501(c)(3) and certain non-501(c)(3) nonprofits); small businesses; other for-profit organizations (excluding small businesses under the separate small business category); and government entities (including state, county, city/township, special district governments, and eligible federal agencies). The FOA also notes eligibility for minority-serving institutions, faith-based or community-based organizations, U.S. territories or possessions, and non-U.S. entities/foreign organizations, among others.
Does broad eligibility mean any institution is likely to be competitive?
The FOA emphasizes that beyond basic eligibility, applicants need the practical capacity to coordinate a multi-site pediatric PVD effort and execute both the informatics-heavy EHR strategy and the controlled traditional prospective strategy in parallel.
What specific disease area is the coordinating center focused on?
The focus is pediatric pulmonary vascular disease (PVD), described as a rare and heterogeneous pediatric condition.
What is the core methodological challenge this FOA is trying to address?
The FOA targets the challenge of generating credible, scalable evidence in a rare, heterogeneous disease across multiple institutions by testing whether EHR-derived prospective data can answer key natural history, outcomes, and treatment-response questions as well as (or differently than) traditional prospective research-grade data.
What are examples of the kinds of outcomes this effort may consider?
The FOA references longitudinal outcomes such as clinical trajectories, morbidity, mortality, utilization, and functional status as examples of outcomes that may be evaluated, depending on the applicant-selected research questions.
What is meant by "phenotypes of therapeutic response" in this context?
In this FOA, phenotypes of therapeutic response refers to identifying patient subgroups among children treated for PVD that respond differently to specific treatments, and testing how well each data strategy can support those subgroup and response characterizations.
How does the FOA describe the limitations of EHR-derived data?
The FOA notes that EHR data can be messy, incomplete, inconsistently coded, and dependent on local documentation habits, which can introduce biases and complicate longitudinal tracking and exposure/outcome measurement.
How does the FOA describe the limitations of traditional prospective research cohorts?
The FOA notes that traditional prospective cohorts can capture detailed, standardized variables, but they are expensive, slow to scale, and often limited in sample size.
What is meant by comparing "credibility, completeness, timeliness, and generalizability" of answers?
The FOA indicates that the intent is not only to see whether each pipeline can produce an answer, but to compare the strength of those answers, including how complete the relevant data are, how quickly answers can be generated, how believable/valid the measures are, and how well findings generalize to real-world pediatric PVD care.
What does "prospective" imply in this FOA?
Within the FOA description, the comparison is framed around building two prospective data-collection pipelines, meaning the data strategies are planned and implemented forward-looking rather than relying only on previously assembled datasets, and they are used to address the same research questions side by side.
Is the goal to replace traditional prospective research with EHR data?
The FOA frames the work as a rigorous comparison to identify where EHR-based approaches can reliably answer real-world clinical management questions, where traditional prospective research collection remains necessary, and how the two might be combined or optimized.
What is the overarching outcome NHLBI wants from this coordinating center?
The FOA seeks practical, evidence-based direction for pediatric PVD outcomes research and trial readiness: what EHR-derived methods can contribute, what their limitations are, and how to improve outcome measurement, subgroup identification, and efficient cohort assembly and follow-up.
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