Secondary analyses in obesity, diabetes, digestive and kidney diseases.

The specific objectives of this announcement on Secondary Analyses In Obesity, Diabetes, Digestive And Kidney Diseases are to support the following: (a) research on secondary analyses of data related to the epidemiology of disease areas of NIDDK; (b) preliminary projects using secondary analysis that could lead to subsequent applications for individual research awards; (c) rapid analyses of new databases and experimental modules to inform the design and content of future studies; (d) the archiving of data sets to be made publicly available for research purposes related to disease areas of NIDDK, including both epidemiological studies and multi-center clinical trials.

Research that employs analytic techniques that demonstrate or promote methodological advances in patient-oriented and epidemiologic research is also of interest. International comparative analyses are encouraged. Applications that are innovative and high risk with the likelihood for high impact would be especially encouraged.

Patient-oriented and epidemiologic research projects, particularly multicenter projects, typically generate data with potential utility beyond the specific hypotheses and questions for which they were designed. Often data are not fully analyzed, especially when unexpected research questions emerge after the end of the project's funding period. Analyzing such existing data sets can therefore provide a cost-effective means to test specific hypotheses that have not been adequately examined. The further analysis of existing research data may also be prompted by a need to confirm new findings or to aid in the development of new research questions.

Applicants may conduct secondary analyses using data from a variety of sources. These would include investigator-initiated research activities, cooperative agreements, and contracts or from other public or private sources. Sources may be large, nationally representative data sets such as those of the National Center for Health Statistics or smaller, regional or locally based data sets. Also appropriate for secondary analyses are relevant cross-sectional and longitudinal survey data collected by federal, state, and local government agencies. Secondary data analyses of these data may serve as an economical alternative to expensive and time-consuming new data collection projects. Applicants may also secure access to other data sets that may or may not be in the public domain, such as those collected under research grant funds, sponsored by private entities, or originally collected for purposes other than research, such as health care administrative data sets.

In addition to the examination of specific research hypotheses, existing data sets may also be used to cross-validate exploratory analyses in ongoing studies, to test complex statistical models, and in special circumstances to provide comparison groups for experimental studies. Moreover, secondary analysis is appropriate for many types of data, including qualitative information, and may also cover the integration of quantitative and qualitative data.

NIDDK has established a repository for the archiving of data sets, as well as genetics and tissues from NIDDK sponsored clinical trials and epidemiological studies (http://pubnts06.rti.org/niddk/ home.do). Applicants are encouraged to consider the research opportunities available in this NIDDK resource.

A major interest of NIDDK is supporting secondary data analyses in the causes, burden, natural history, and treatment and medical care of overweight and obesity, including analyses of behavioral/environmental factors that may be predictive of long term weight maintenance or prevention of weight gain. Other specific subject areas are restricted to those on which NIDDK conducts research, which include diabetes and endocrine and metabolic diseases; digestive diseases and nutritional disorders, including eating disorders; and kidney, urological, and hematological diseases. All data analyses must concern patient-oriented or epidemiologic research designed to elucidate the etiology, incidence, prevalence, natural history, pathophysiology, or response to therapy of the abovementioned disorders.

This program announcement addresses several areas considered to be high priority for liver disease research as delineated in the recently published Trans-NIH Action Plan for Liver Disease Research (http://liverplan.niddk.nih.gov), specifically in the areas of fatty liver disease, viral hepatitis, drug- and toxicant-induced liver disease, autoimmune liver disease, pediatric liver disease, liver transplantation, complications of liver disease, and gallbladder and biliary disease.

This mechanism can also be used for the merging of secondary data sets with other data sets. For example, if allowed by informed consent, databases could be matched with hospital data sets or vital statistics to assess longer-term morbidity and/or mortality of patient groups. Meta-analysis, in which results from multiple studies may be compared or combined, is encouraged only if patient level data from the original studies are combined.

Support for the creation of publicly archived data sets involved in secondary analyses would be for information that could be applied to the subject areas of interest. Plans for archiving must include adequate dataset documentation and explanation so that it can be used by researchers not associated with the original study. Provision for easy accessibility of archived datasets is required.

Up to 25% of the direct costs of the grant may be spent on acquiring new information that would be incorporated into the database and would significantly strengthen the analysis. Such information may, for example, be derived from laboratory testing of stored specimens or comparisons of a measurement against a criterion standard to validate the measurement in the database. Conversion of data from paper records to electronic form would also be considered up to the 25% limit. Obtaining such new information must serve the purpose of the secondary data analysis and should not be considered for any other reason.

This funding opportunity will use the NIH Exploratory/Developmental (R21) award mechanism. As an applicant, you will be solely responsible for planning, directing, and executing the proposed project.

This funding opportunity uses just-in-time concepts. It also uses the modular budget format described in the PHS 398 application instructions (see http://grants.nih.gov/grants/funding/modular/ modular.htm).

The PHS 398 application instructions are available at http://grants.nih.gov/grants/funding/phs398/ phs398.html in an interactive format. Applicants must use the currently approved version of the PHS 398. For further assistance contact GrantsInfo at 301-435-0714 (telecommunications for the hearing impaired: TTY 301-451-0088) or by e-mail: [e-mail].

Applications must be prepared using the most current PHS 398 research grant application instructions and forms. Applications must have a D&B Data Universal Numbering System (DUNS) number as the universal identifier when applying for Federal grants or cooperative agreements. The D&B number can be obtained by calling 866-705-5711 or through the web site at http://www.dnb.com/us/. The D&B number should be entered on line 11 of the face page of the PHS 398 form. The complete version of this PA is available at http://grants.nih. gov/grants/guide/pa-files/PA-05-091.html.

Contact: James E. Everhart, Epidemiology and Clinical Trials Branch, Division of Digestive Diseases and Nutrition, National Institute of Diabetes and Digestive and Kidney Diseases, 6707 Democracy Blvd, Rm 655, Bethesda MD 20892-5450 USA, 301594-8878, fax: [phone], e-mail: [e-mail]; Catherine C. Cowie, Type 1 Diabetes Clinical Trials Program, Division of Diabetes, Endocrinology, and Metabolism, National Institute of Diabetes and Digestive and Kidney Diseases, 6707 Democracy Blvd, Rm 691, Bethesda, MD 20892-5460 USA, 301594-8804, fax: [phone], e-mail: [e-mail]; Paul W. Eggers, Epidemiology and U.S. Renal Data System, Division of Kidney, Urologic, and Hematologic Diseases, National Institute of Diabetes and Digestive and Kidney Diseases, 6707 Democracy Blvd, Rm 615, Bethesda, MD 20892-5458 USA, 301 594-8305, fax: [phone], e-mail: pe39h@ nih.gov. Reference: PA No. PA-05-091