NHLBI Participation in NIH Research and Research Infrastructure “Grand Opportunities”

NHLBI Participation in Research and Research Infrastructure “Grand Opportunities” (RC2)  (RFA-OD-09-004)

The NIH has received new funds for Fiscal Years (FYs) 2009 and 2010 as part of the American Recovery & Reinvestment Act of 2009 (“Recovery Act” or “ARRA”). This program, titled Research and Research Infrastructure “Grand Opportunities” or “GO” grants is one of a number of NIH initiatives related to the Recovery Act, all of which are listed at: http://grants.nih.gov/recovery/.   It will support projects that address large, specific biomedical and biobehavioral research endeavors that will benefit from significant 2-year funds without the expectation of continued NIH funding beyond two years.  Research supported by the “GO” grants program should provide a high short-term return and offer a high likelihood of enabling growth and investment in biomedical research and development, public health, and health care delivery.

NHLBI RC2 Topics

Comparative Effectiveness

For many acute and chronic medical conditions, clinical practitioners are faced with a myriad of management options, including multiple drugs, devices, procedures, behavioral interventions, and implementation methods. Clinical epidemiologists have documented widespread practice variation for most conditions and medical interventions with much of the variation apparently due to the lack of systematic evidence regarding how different medical services compare with one another. Comparative effectiveness research attempts to compare rigorously the effects of different available options on clinical outcomes, in order to inform clinical practitioners about how to provide the right services for the right patient at the right time in the right setting. While comparative effectiveness research can be highly informative, it also presents numerous methodological and logistical challenges.

For the purposes of this RFA, comparative effectiveness research is defined as “Comparative effectiveness research (CER) involves the conduct, support, or synthesis of research that compares the clinical outcomes, effectiveness, and appropriateness of items, services, and procedures that are used to prevent, diagnose, or treat diseases, disorders, and other health conditions. CER uses a variety of data sources and methodologies, including patient registries, clinical data networks, pragmatic clinical trials, decision analyses, and meta-analyses to produce rigorous and valid evaluations.

CER studies typically focus on comparing the impact of different options on comprehensive health outcomes, including patient mortality, morbidity, quality of life, and performance of the health system. The overarching goal is to provide better evidence so that individual patients will receive effective, efficient, patient-centered care.”

This funding opportunity will support two-year efforts that will substantially accelerate comparative effectiveness research, advance methods development and priority setting, and forge robust infrastructure to support the conduct of comparative effectiveness research. Illustrative examples of responsive projects include those that target heart, lung, and blood diseases and those that:

1. Plan initiatives (including feasibility and vanguard studies) to prepare for the launch of large-scale pragmatic comparative effectiveness trials of interventions for medical conditions of substantial public health or public policy importance.

2. Develop and/or advance analytic techniques and quantitative methods for analyzing comparative effectiveness clinical trials.

3. Design and evaluate complex simulations and statistical models designed to enable researchers, funding agencies, practitioners, and policymakers to make informed systematic decisions regarding priorities for studies of comparative effectiveness.

4. Establish or enhance user-friendly registries that can be queried and used to identify subjects, enroll them rapidly, and then follow them over time for large-scale trials or other CER studies.

Contact: Michael Lauer, Tel: 301-435-0422, Email: lauerm@nhlbi.nih.gov

Novel Methods of Monitoring Health Disparities

Population disparities in health and mortality have increased in the United States since the 1980s, with increases in mortality and poor health being most pronounced among the most disadvantaged.  The causes of disparities and their trends over time are poorly understood.  Some of the disparities may be due to differential prevalence of traditional risk factors such as smoking, hypertension, obesity, and unhealthy diets, while others are likely to be related to limited access to health care, socioeconomic status, and cultural characteristics.  The current economic downturn may worsen health disparities, while the potential for health care reform raises new uncertainties.  Therefore, the current environment offers a unique natural experiment by which we can learn much about social, biological, demographic, and economic influences on health; high quality research could play a critical role in informing and evaluating public policy and clinical practice.

The availability of high-quality population data derived from carefully designed epidemiological and socio-economic examinations and analyses will be essential for efforts to design changes in the U.S. health care system and in public health interventions that will reduce health disparities. A systematic strategy for monitoring key risk factors and the effects of health related policies and reforms is urgently needed.  The monitoring should be conducted against a background of pre-defined, existing data appropriate for understanding important population subsets defined not only by geography but also by socio-economic or socio-cultural characteristics.  Finally, epidemiological investigations should develop strategies for communicating with policy makers and health care providers about how changes in the various influences on health interact with actual outcomes.

The objective of this solicitation is to support initial work designed to test the feasibility, over the next two years, of novel approaches to collect extensive, enriched data on health disparities in chronic diseases, monitor economic effects on health, and evaluate the effects of changes in health care policy.

Contact:  Michael Lauer, Tel: 301-435-0422, Email: lauerm@nhlbi.nih.gov

The NHLBI BioResource Program:  Creation of Resources Designed to Accelerate Scientific Progress in the Areas of Heart, Lung, and Blood Diseases; Cellular Therapies; and Blood Safety

The NHLBI will provide support for heart, lung, and blood research projects that will also produce collections of well-phenotyped and/or genotyped biospecimens.  Upon completion of the projects, all resultant biospecimens, including human tissue, blood, urine, and/or other human-derived material such as cells, cell lines, and genetic material will be expected to be submitted to the NHLBI Biological Specimen Repository for broad access by the scientific community.

Proposed research projects should foster scientific progress in the areas of heart, lung, and blood diseases, including cellular therapies for one or more of them, and/or blood safety by addressing scientific topics of fundamental and/or clinical relevance such as identifying the factors influencing the risk or progression of disease, the complications associated with disease, or the risks and benefits associated with therapies including blood and cellular therapies. Examples include studies to identify biomarkers; examine the pathophysiologic and inflammatory mechanisms underlying heart, lung, and/or blood disorders; and identify factors influencing the development of microchimerism, alloimmunization, and other complications of blood and cellular therapies.  Proposed projects should include the phenotypic and/or genotypic characterization of biospecimens from human subjects with heart, lung, and/or blood diseases and traits, or from donors and/or recipients of blood transfusion and cellular therapies. Participant consent must permit wide sharing of data and biospecimens for research.

Applicants should delineate the specific scientific problem(s), gap area(s), or opportunity(ies) that are being targeted by the proposed project.  They should also include a description of the population(s) from which they propose to collect biospecimens; the nature of those biospecimens; the research hypotheses to be tested; a rationale for gathering the proposed phenotypic and/or genotypic information; an explanation of how the collection and analysis of the phenotypic and/or genotypic data will help answer the research hypotheses being tested and advance heart, lung, and blood research; a description of the desired experimental approaches (e.g., histological characterization, molecular analysis) that will be used to obtain the phenotypic and/or genotypic data; the procedures to be used for biospecimen collection, preparation, and storage; the size of the proposed collection and its potential future value and/or uses; the data elements to be provided in the publicly available database that will accompany the biospecimen collections; and the plans for disseminating study outcomes.  Applicants should include in their research teams individuals with expertise in population and statistical methodology, informatics, clinical phenotyping and description of data elements, relevant laboratory methodologies, and handling and management of high quality biospecimens for research use.  Where available, genomic data (SNP patterns and sequencing) must be deposited into the Database for Genotypes and Phenotypes (dbGaP) maintained by the National Center for Biotechnology Information and made available for sequence and phenotype-genotype analyses in accordance with NIH GWAS data sharing policies.

At the conclusion of the funding period, biospecimens and their associated phenotypic and/or genotypic information will be transferred to the NHLBI Biologic Specimen Repository and the NHLBI Biologic Specimen and Data Repository Information Coordinating Center (BioLINCC) for long-term storage and distribution to the scientific community.  Information on the NHLBI Biologic Specimen Repository can be found at http://www.nhlbi.nih.gov/resources/medres/reposit/reposit.htm.  Applicants are also encouraged to refer to NCI Best Practices for Biospecimen Resources, June 2007 available at http://biospecimens.cancer.gov/practices/ for a description of best practices for biospecimen resources.

Contact:  Simone Glynn, Tel: 301-435-0065, Email: glynnsa@nhlbi.nih.gov

Large-scale DNA Sequencing and Molecular Profiling of Well-phenotyped NHLBI Cohorts.

Note: All potential applicants for an RC2 award to address this topic should also read the Addendum to this topic, which appears immediately after the topic description.

Genomic technologies have advanced to the point where large-scale DNA sequencing and molecular profiling—including genome-wide mRNA, miRNA, and epigenomic assays—can be undertaken at the level of entire human cohorts.  Moreover, multidimensional investigations conducted on the same cohort and involving a combination of genotypic, clinical phenotypic, and one or more molecular phenotypic analyses will enable integrative computational reconstruction of predictive disease networks and the generation of novel mechanistic hypotheses for disease etiology.  The NHLBI will provide support for studies using existing samples from study populations that include diseases and clinical traits in the spectrum of heart, vascular, lung, and blood disorders that focus on either or both of the following types of genome-scale approaches:

1. In-depth identification of disease-causing genetic variants using large-scale sequencing of human subjects from longitudinal population cohorts that
   
   
• have been well-phenotyped for a comprehensive set of cardiovascular, metabolic, lung, and/or blood diseases and clinical traits, and
• represent multiple ethnicities, including individuals of European and African descent.

Case-control proposals will not be considered responsive to this solicitation.  The study must be designed to emphasize discovery of large numbers of high-probability causal variants, including those having very low minor allele frequencies.  A combination of whole-genome and whole-exome sequencing in thousands of individuals can be included, with additional statistical power attained by follow-up genotyping in many tens of thousands of individuals from comparable cohorts using a custom-designed microarray targeting identified sequence variants.  The DNA sequencing component should make efficient use of available funds by taking into account the population and family structures of the samples, and by providing a balance among numbers of samples sequenced, sequencing depth per sample, instrument throughput and total available capacity, informativeness of whole-genome vs. exome sequence data, and plans for subsequent replication and validation by array-based genotyping. 

2. Molecular profiling of blood or tissue samples from individuals with heart, vascular, lung, or blood disorders.  These studies must employ a combination of high-throughput measures (e.g., mRNA or miRNA expression profiling or epigenomic assays) to probe mechanisms of susceptibility, pathogenesis, and responses to therapies, or to provide signatures of disease states, subtypes, or progression.  Case-control designs will be allowed, and cohorts of several hundred to several thousand subjects may be included.  Analyses are expected of not just blood specimens, but also other tissues or cells involved in disease processes.  Prospective collections of specimens will not be supported.  Studies that are able to combine genotypes, multiple clinical traits, and molecular phenotypes are especially encouraged.  The choice of analytical technologies is at the discretion of the applicant, but each must be justified based on the value of the information to be gained, experimental throughput, total available capacity, cost-effectiveness, and quality and quantity of data generated.

Proposed budgets should include an allowance for a data coordination and analysis center, but equipment purchases will not be supported.  Multidisciplinary research teams should be formed and should include personnel with appropriate expertise (e.g., clinical medicine, epidemiology, population and statistical genetics, informatics, high-throughput DNA sequencing, genotyping, and RNA- and DNA-based molecular profiling).  All resultant data must be deposited into the Database for Genotypes and Phenotypes (dbGaP) maintained by the National Center for Biotechnology Information and for subsequent use in genotype-phenotype analyses in accordance with existing NIH GWAS data sharing policies.  The NHLBI will work closely with investigators affiliated with experimental laboratories and with NHLBI-supported cohorts to provide overall coordination and governance of this program, to select the eligible cohorts and most appropriate research participants, to establish the scientific direction of genotype-phenotype analyses, to address prospectively ethical, legal, and social issues related to large-scale human DNA sequencing, and to ensure that data are made widely available to other analytic teams to facilitate new discoveries while protecting participant confidentiality. 

Contact:  Alan M. Michelson, Tel : 301-594-5353, Email: michelsonam@nhlbi.nih.gov

Addendum to Large-Scale DNA Sequencing and Molecular Profiling of Well-phenotyped NHLBI Cohorts.

An application to this Grand Opportunity (RC2) RFA topic will be considered responsive if it focuses solely on either the DNA sequencing or population cohort aspects of the overall project.  Indeed, the NHLBI encourages applications that address only one of these two areas and will review the two types of applications separately.

After awards are made, the NHLBI will convene a steering committee—comprising successful applicants, outside experts, and NIH representatives—to develop the overall governance, design, and process for coordination of the project.  In addition, if more than one sequencing center is involved in the project, the steering committee will oversee the assignment of DNA samples to individual centers as part of its coordinating function.

Applicants with expertise in DNA sequencing technology should emphasize the specific methods to be used, the genomic regions to be targeted, and the depth of sequence coverage to be obtained, as well as the anticipated sample throughput, total capacity, variant calling strategies, and quality metrics that they will apply.  They should also describe a comprehensive data management plan and include a discussion of the cost-effectiveness of the proposed experimental approach as a part of the justification for the total requested budget.

Applicants who oversee studies of well-phenotyped population cohorts should provide the following additional information:

• An enumeration of phenotypes available and the total numbers of samples in each phenotypic category
• The ethnic diversity and family structure of subjects,
• The quality and quantity of available DNA samples and their readiness to be shipped for immediate entry into the sequencing pipeline
• A certification that the existing informed consents will permit deposition in dbGaP of all data for the cohort, whether existing prior to application for this grant program or derived with support from this grant program (the certification should also include a statement of intent to adhere to the data sharing and publication policies previously established by the NIH for genome-wide association studies).

Collaboration among cohorts is strongly encouraged for designing studies with sufficient power to uncover statistically significant associations between variants having different allele frequencies and clinical traits or diseases of interest.

All applicants should provide a detailed plan for data analysis—both primary sequence and genotypic-phenotypic association studies—that takes into account the projected timeline for sequence generation.

Next Steps in Gene Discovery:  Building upon GWAS

Although genome-wide association studies (GWAS) have been successful in identifying a rapidly growing number of genetic variants that are associated with numerous common complex traits and diseases, including heart, lung, and blood diseases, the variants only explain a small percentage of the overall genetic variance in the associated traits or diseases.  Moreover, efforts to replicate or validate findings or to develop hints regarding underlying mechanisms, or to translate results into clinical application have been slow to progress.  The NHLBI has invested more than $100 million in GWAS of over 100,000 individuals.  The Next Steps comprise a multifaceted approach to build upon that investment.  The objective of this solicitation is to accelerate GWAS follow-up; it is not intended to fund new GWAS.  The following areas of research would be of interest:

1. Support for additional genotyping or biomarker assays in existing samples (not to include recruitment, sample collection, or examinations) for GWAS.  Examples of high-priority research would include:
• Support for additional genotyping and analysis for phenotypes of high clinical interest to obtain sufficient sample size to replicate and validate initial GWAS findings.
• Support for standardized measurement of biomarkers using existing stored samples from GWAS to enable GWAS to fill in the gaps and increase sample size of existing biomarker measures (e.g., lipids, CRP, glucose, and other laboratory measures) in a standard manner across studies for GWAS analysis.
• Support to replicate and validate GWAS findings in additional populations of varied geographic origin and ethnicity and to enable targeted genotyping and analysis in existing samples from populations of varied geographic origin and ethnicity.
2. Assemble and support consortia to provide in depth analysis and methods development to follow up on initial GWAS findings.  Examples of supported research include:  methods for gene-x-gene analysis, gene-x-environment analysis, and meta-analysis; network approaches; and integration of environmental, epigenomic, expression, proteomic, and/or sequencing data with GWAS.
3. Develop a heart, lung, and blood disease specific genotyping chip,to be available to all NHLBI supported GWAS; the choice of SNPs to be included to be based on results from GWAS and genome sequencing of heart, lung, and blood disorders, with additional SNPs chosen to provide fine mapping in regions of interest.
4. Support mechanisms to enable translation of GWAS and other genetic findings into a clinical setting, including the development of tools and algorithms for disease risk assessment and prediction using significant ‘hits’ from GWAS and GWAS follow up along with other clinical and demographic information.  However, efforts to assess the effectiveness of such tools or algorithms in improving clinical outcomes would not be supported under this mechanism.
5. Initial development of ELSI and genetic results notification and counseling programs that focus on individual and community education and communication surrounding the significance of individual genotyping and sequence results from GWAS and GWAS follow up.

All data generated through this program will be openly available to the scientific community, preferably through the NIH GWAS data repository (dbGAP).  All software, tools, and methodology developed in this program must be made publically available to the scientific community.  The NHLBI will work closely with investigators supported by the program to provide close overall coordination, encourage collaboration, and facilitate rapid dissemination of all data, software, tools, and methodology they develop.

Program Contact:  Cashell E. Jaquish, Tel: 301-435-0447, Email: jaquishc@nhlbi.nih.gov

Characterizing Differentiated Heart, Lung, and Blood Cells Derived by Reprogramming Human Embryonic and Induced Pluripotent Stem Cells.

Considerable progress has recently been made in the field of cellular reprogramming, including the induction of pluripotent stem cells from a diversity of adult somatic cell types, and the directed differentiation of stem cells of both embryonic and adult origin into a variety of cellular derivatives.  To assess the value of these unique cell sources in the development of model experimental systems, and to evaluate their safety and efficacy in potential therapies, several urgent questions remain to be addressed, including:  (1) How do the differentiated states generated by reprogramming stem cells in the laboratory compare with the characteristics and fates of their normal tissue and organ counterparts?  (2) How do the differentiated states generated by reprogramming embryonic and induced pluripotent stem cells compare with each other?  (3) How does genetic background influence the efficiency of cellular reprogramming strategies and the phenotypic properties of the resultant differentiated cells?  The NHLBI will support studies that address one or more of these three problems as they relate to cells of the human cardiovascular, lung, and blood systems.  Similar investigations in model organisms, and efforts that focus solely on reprogramming methods, will not be considered responsive to this solicitation.  However, efforts to compare existing reprogramming protocols or to develop strategies for targeted differentiation of cardiovascular, lung, or blood cells from human embryonic or induced pluripotent stem cells, may be included provided that one or more of the above questions is also addressed.

Program Contact:  Alan M. Michelson, Tel: 301-594-5353, Email: michelsonam@nhlbi.nih.gov

Testing of Mechanistic Hypotheses Generated by Findings from Genetic and Genomic Studies of Heart, Vascular, Lung, and Blood Disorders.

Recent genome-wide association and other types of genetic and genomic studies of complex human traits and diseases have provided a wealth of information about possible molecular pathophysiological mechanisms.  However, few of those mechanisms have been rigorously validated.  Functional studies must now be undertaken using appropriate experimental models to determine how candidate disease-causing genes act in normal biological processes, how specific genetic variants alter those processes, and how the altered processes disrupt homeostatic mechanisms.  The NHLBI will support highly focused studies that address this overall problem and that can be either completed or at least provide significant advances in mechanistic understanding within a two-year funding period.  Possible approaches to delineating pertinent genotype-phenotype correlations include but are not limited to:

• genetic manipulations of model organisms
• analyses of cell-based disease models of defined genotype
• in silico predictions of the deleterious effects of coding and noncoding genetic variants
• empirical determinations of the effects of noncoding variants on gene expression or other cis-acting regulatory genomic functions
• in vitro or in vivo assays of normal and altered protein or noncoding RNA functions
• systems-level approaches such as the prediction and assessment of pathway and network responses to specifically targeted genetic or RNAi-based perturbations using appropriate molecular or cellular assays
• development and application of assays that reveal the pleiotropic functions of genes in normal and disease states
• testing of gene-gene or gene-environment interactions by determining the effects of combinatorial perturbations of informative systems
• development and application of novel high-throughput strategies for parallel examination of multiple disease-associated genetic variants, genes, or genomic regulatory elements
• quantitative assays for evaluating the effects of allelic series of mutations.

Multiple, independent approaches with convergent lines of evidence can strengthen hypothesis testing in the present context and are strongly encouraged.  Collaborations are encouraged among investigators with different areas of expertise, including those with specialized knowledge in clinical medicine, human genetics, and relevant basic sciences.   To be responsive, proposals must focus on genes or genomic regions having statistically high-confidence associations with heart, vascular, lung, or blood disorders.

Program Contact:  Alan M. Michelson, Tel: 301-594-5353, Email: michelsonam@nhlbi.nih.gov

Translation of Fundamental Research Findings into Clinical Treatments for Heart, Lung, and Blood Diseases
The ultimate goal of biomedical research is to develop new knowledge that will lead to improvements in public health.  Fundamental research studies in cells, tissues, and animal models and investigations of biomarkers and functional genomics have all greatly expanded our understanding of the pathogenesis of many heart, lung, and blood diseases and have also provided a range of potential new approaches for their prevention and treatment.  Yet the translation of basic research findings to clinical testing has often been disappointingly slow, with good ideas and new findings sometimes languishing for years before being tested for efficacy in a clinical setting.  Three different opportunities to hasten the transition of research findings into clinical practice are described below.

1) NHLBI Translational Research Implementation Program (TRIP) -- This two-stage program is designed to translate fundamental research ideas to proof-of-concept efficacy testing in patients.  In the Stage 1 TRIP program, the NHLBI will fund two-year awards to support preliminary studies that culminate in the development of one or more well-designed, ready-to-conduct clinical trials.  In the forthcoming five-year Stage 2 portion of the TRIP program (to be solicited 18 months following initiation of the Stage 1 awards), the NHLBI will use regularly appropriated NHLBI funds to support the most meritorious trials developed under Stage 1.  The competition for Stage 2 awards will be limited to Stage 1 awardees. 

For Stage 1 awards supported by Grand Opportunity (GO) grants, investigators may request 2 years of support for activities required to design clinical trials to evaluate safety and efficacy of new modalities to treat and prevent cardiovascular, lung, and blood diseases based on promising ideas that have emerged from basic research.  Such activities might include (but are not limited to):

• Piloting procedures to assess the feasibility of applying novel fundamental research findings to treat or prevent cardiovascular, lung, and blood diseases in appropriate large animal models.
• Analyzing existing clinical data
• Performing other activities required to obtain an FDA IND or IDE (e.g., conduct a small, dose-escalation study in patients or normal volunteers to assess safety of a new biological or drug product)
• Establishing an appropriate research team, including establishment of appropriate third-party agreements
• Developing necessary tools for clinical data management and oversight
• Defining recruitment strategies and developing a recruiting network and a mechanism for its oversight
• Finalizing a trial protocol and other essential elements of a trial design to be supported by a second stage of award

Each NHLBI TRIP Stage 1 GO application must provide a rationale for the clinical trial to be developed and supply evidence that the intervention to be tested is based on recent and sound fundamental research findings.  In addition, each Stage 1 GO application must clearly delineate performance milestones that must be completed within the two years of Stage 1 GO support and that would reasonably assure the feasibility of completing a subsequent safety and efficacy trial.

The title of each NHLBI TRIP Stage 1 GO application must begin with “CTRIP:” and must not exceed 81 characters in total length, including spaces and punctuation.

Contact:  David A. Lathrop, Tel: 301-435-0507, Email: lathropd@nhlbi.nih.gov

 

2) Phase II Clinical Trials Program of Novel Therapies for Heart, Lung, and Blood Diseases --  This program will support Phase II clinical treatment trials of novel therapies or diagnostic strategies for heart, lung, or blood diseases that offer the potential to change clinical practice and are ready to be tested in patients.  For the purpose of this Grand Opportunity (GO), a Phase II trial is a proof-of-concept, randomized, interventional, human study that will most likely use physiological or biochemical, rather than clinical endpoints.  Research conducted under this program is intended to result in high quality data that could lead to efficacy or Phase III trials that could be either conducted in a network or as an investigator-initiated study.  The proposed intervention or strategy must be novel and offer high promise for modifying current treatments or diagnostic approaches and/or altering the clinical course of a disease.  Innovative clinical trial designs are also encouraged.
Studies must seek to improve diagnosis or treatment of a heart, lung, or blood disease using novel approaches.  Some studies include (but are not limited to):

• placebo-controlled studies of novel compounds or devices
• blockade or enhancement of novel pathogenetic pathways
• progenitor cell treatments, 
• novel applications of approved drugs, or diagnostic techniques
• novel clinical management practices or diagnostic strategies, which could be tested as long as an important effect on clinical outcomes or treatments is expected

The principal investigator should have demonstrated expertise in clinical studies.  Subcontracts to assist with recruitment are encouraged.  An application must include an appropriate data and safety monitoring plan and an appendix that includes the protocol and a sample informed consent.  IRB approval must be in place at the time of award.  If an IDE or IND is required, evidence of FDA approval will be required at the time of award.  Each application should include clear milestones that will be rigorously monitored during the funding period.

Proposed projects must be for a maximum of two years, and must be mature, and ready to begin immediately after award.  Because the nature and scope of proposed projects are expected to vary, the size of the awards is expected to vary as well.  However, the requested budget should not exceed $1,515,000 direct costs per year and should be commensurate with the trial proposed.

Phase I safety studies, dose-response studies, large phase III efficacy studies, or trials to compare endpoints in patients treated with drugs from within a class of currently used drugs are not acceptable under this Program.  Animal studies are not permitted.

Each NHLBI application in response to this NIH GO Grant topic must have a title that begins with “Phase II” and is no longer than 81 characters in total length, including spaces and punctuation.

Contact:  Andrea L. Harabin, Tel: 301-435-0222, Email: harabin@nih.gov

 

3) Ancillary Studies Program -- This program will support research studies that leverage ongoing, large clinical studies to enhance our understanding of the mechanisms involved in the pathogenesis and treatment of heart, lung, and blood disorders.  The objectives, requirements, and restrictions of RFA-HL-09-001 apply, except for the budgetary and year requirements, which will defer to the Grand Opportunities (GO) RFA-OD-09-004, including a minimum budget of $500,000 or more in total costs, a categorical budget, and a maximum of two years duration.  Applications that extend a parent study, are not time-sensitive, or devote large resources to recruitment of new subjects will be considered nonresponsive. 

Each NHLBI ancillary studies GO application submitted in response to this NIH GO Grant topic must have a title that begins with “Ancillary” and is no longer than 81 characters in length, including spaces and punctuation.

Contact:  Abby Ershow, Tel: 301-435-0550, Email: ershowa@nhlbi.nih.gov

For general information on the NHLBI’s implementation of NIH Grand Opportunities Grants, contact:
Carl Roth, Ph.D., LL.M.
Tel: 301-496-6331
Email: rothc@nhlbi.nih.gov

For Review questions, contact:
Valerie Prenger, Ph.D.
Tel: 301-435-0270
Email: nhlbichiefreviewbranch@nhlbi.nih.gov

For Financial or Grants Management questions, contact:
Robert Vinson
Tel: 301-435-0169
Email: vinsonr@nhlbi.nih.gov

Letters of Intent

Letters of Intent are due by April 27, 2009 and may be sent by mail, courier, fax, or email:
Chief, Review Branch
Division of Extramural Research Activities
National Heart, Lung, and Blood Institute
6701 Rockledge Drive
Room 7214, MSC 7924
Bethesda, MD 20892-7924 (Express zip: 20817)
Telephone: (301) 435-0270
FAX: (301) 480-0730
Email: nhlbichiefreviewbranch@nhlbi.nih.gov

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