Full Text DK-97-008 CHRONIC PROSTATITIS COLLABORATIVE CLINICAL STUDIES NIH GUIDE, Volume 26, Number 7, March 7, 1997 RFA: DK-97-008 P.T. 34 Keywords: Urogenital System Urology Clinical Medicine, General National Institute of Diabetes and Digestive and Kidney Diseases Letter of Intent Receipt Date: March 17, 1997 Application Receipt Date: May 14, 1997 PURPOSE The Division of Kidney, Urologic and Hematologic Diseases (DKUHD) of the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) invites research project grant (R01) applications for four collaborating Clinical Research Centers (CRC) and one biostatistical support center (BSC) to participate in an interactive chronic prostatitis clinical research group (CPCRG). Chronic prostatitis is a significant problem for many men and their family members. A recent NIDDK sponsored workshop on chronic prostatitis developed a system to classify patients with prostatitis with each category having distinct diagnostic criteria. The majority of patients with prostatitis are in the "chronic category" which is based upon specific characteristics of the prostatic fluid. The purpose of this Request for Applications (RFA) is to provide support for investigators to collaboratively study patient self-reported symptoms and the objective diagnostic findings in men with chronic prostatitis (i.e., pain or discomfort in the pelvic area, no demonstrable infection using routine clinical methodology). Emphasis should be placed on state-of-the-art techniques to characterize the prostatic secretions of men with chronic prostatitis. Another area of emphasis is the development and validation of a survey instrument to assess self-reported severity of illness in these men. Each participating CRC in collaboration with the other CRCs will develop and carry out uniform and standardized research protocols to study the biological characteristics of prostatic fluid in men with chronic prostatitis in the hopes of better defining the etiology of this condition. Prior to conducting such objective laboratory studies it will be necessary to develop and validate a symptom/severity questionnaire to characterize the subjective aspects of the disease. HEALTHY PEOPLE 2000 The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2000," a PHS-led national activity for setting priority areas. This RFA, Chronic Prostatitis Clinical Research Centers, is related to the priority areas of chronic disabling conditions and clinical prevention services. Potential applicants may obtain a copy of "Healthy People 2000" (Full Report: Stock No. 017-001-00474-0 or Summary Report: Stock No. 017-001-00473-1) through superintendent of Documents, Government Printing Office, Washington, DC 20402-9325 (telephone 202-512-1800). ELIGIBILITY REQUIREMENTS Applications may be submitted by domestic and foreign, for-profit and non-profit organizations, public and private, such as universities, colleges, hospitals, laboratories, units of state and local governments, and eligible agencies of the Federal government. Applications from minority individuals and women are especially encouraged. Foreign institutions must demonstrate special or unique areas of expertise in order to be considered competitive for an award. MECHANISM OF SUPPORT Support of this program will be through the NIH grants-in-aid research project grant (R01) award. Responsibility for the planning, direction, and execution of the proposed project will be solely that of the applicant. Awards will be administered under PHS grants policy as stated in the PHS Grants Policy Statement. Applicants from institutions that have a General Clinical Research Center (GCRC) funded by the NIH National Center for Research resources may wish to identify the GCRC as a resource for conducting the proposed research. If so, a letter of agreement from either the GCRC program director or principal investigator should be included with the application. This RFA is a one-time solicitation. Future unsolicited competing continuation applications will compete with all investigator-initiated applications and will be reviewed according to the customary peer review procedures. FUNDS AVAILABLE For FY 1997, $1,100,000 will be committed to fund applications submitted in response to this RFA. It is anticipated that up to five awards for Clinical Research Centers (CRC) and one award for a Biostatistical Support Center (BSC) will be made under this RFA. The award for the clinical component of each Clinical Center will not exceed $140,000 direct costs for the first year (protocol development phase). The direct costs awarded for the BSC for the first year (protocol development phase) will not exceed $180,000 direct costs. It is anticipated that the length of award for all centers will be five years. The anticipated award date is September 30, 1997. The number of awards and level of support provided will be dependant upon the receipt of a sufficient number of applications of high scientific merit. Although this program is provided for in the financial plans of the NIDDK, awards pursuant to this RFA are contingent upon the availability of funds for this purpose. RESEARCH OBJECTIVES Background Chronic prostatitis is a chronic, disabling condition affecting untold numbers of men of all ages and ethnic origins. The NIDDK recently sponsored a workshop that was designed to develop a plan to standardize and evaluate various methods of diagnosis and treatment of chronic prostatitis with a long term goal of preventing and effectively treating this condition. The workshop classified prostatitis into four clinical categories. Categories I through III are identified by chronic pain. In addition to pain, categories I and II are readily diagnosed by the presence of infection. In contrast, patients with Category III prostatitis do not have any demonstrable infection of the prostate as determined by conventional microbiological techniques. Abnormalities in the expressed prostatic secretions (EPS) are the primary objective feature. Chronic pain remains the primary subjective symptom. The majority of patients with prostatitis fall into category III (i.e., chronic pain and abnormal EPS). A copy of this workshop report is available from the urology program staff listed under INQUIRIES. Objectives and Scope for Clinical Centers The aim of this RFA is to develop an interactive research network of clinical centers that will validate survey and diagnostic tools which can be used in standardized clinical study protocols including clinical trials, of men who fit the criteria of category III chronic prostatitis (pain or discomfort in the pelvic area, no demonstrable infection using routine clinical methodology). The study population is limited to those men in Category III and, if necessary, appropriately matched controls. It is not the purpose of this RFA to study men with acute and recurrent bacterial prostatitis (using conventional terminology and diagnostic methodology). A high priority of this RFA is to encourage collaborative studies on the characteristics of semen and expressed prostatic secretions (EPS) in men with category III chronic prostatitis and to develop and validate survey instruments and a symptom index which assess the severity of illness in these men. Based on the recommendations of the Prostatitis Workshop, it is anticipated that applicants will propose multi center protocols to: o correlate the characteristics of expressed prostatic secretion (EPS) and/or seminal fluid evaluation in men with chronic prostatitis and with severity of illness; o develop and validate a uniform symptom index for chronic prostatitis, and o validate the diagnostic criteria established by the NIDDK workshop panel. Each of the participating centers will also develop protocols which will also address some of the other recommendations of the workshop which include: o development of a standardized treatment protocol for chronic prostatitis, o development and validation of outcome measures for the chronic prostatitis, o establishment of the relationship between chronic prostatitis, other prostate diseases and lower urinary tract symptoms (LUTS), and the o development of epidemiological studies. It will be advantageous for clinical centers to demonstrate previous clinical research experience both in recruiting patients into clinical studies and in developing and validating diagnostic and assessment tools. Objectives And Scope For The Biostatistical Support Center: Participating investigators will meet together and develop uniform study protocols to evaluate seminal fluid and EPS and to develop and validate a patient self-report symptom questionnaire. The data obtained from these linked studies will be sent to a BSC. The responsibilities of the BSC include, in collaboration with the PIs of the CRCs, development and writing of protocols for the studies and manuals of procedures. The BSC will receive and store all data generated by the CRCs. They will be responsible for assessing data quality, evaluating data collection techniques at the CRCs, establishing procedures for data transmission for the CRCs to the BSC and performing appropriate statistical analyses of the data. Study Design and Population It is envisioned that over the five year period of this project, several multi-center projects that address the important issues identified during the workshop will be developed and implemented by all the participating CRCs. The study population will be enrolled from persons who present with either a clinical diagnosis or the symptoms of chronic prostatitis (Category III) as defined within this RFA. It is envisioned that this population will encompass a broad range of age groups and include a significant minority representation. It is expected that each Clinical Center would have the ability to screen enough men to enroll at least 50 patients per year for three years for enrollment in the various assessment and outcomes validation protocols. It is expected that a single CRC may be participating in more than one validation protocol at the same time. The Principal Investigators of each center will have equal responsibility in developing validation and treatment protocols. One of the roles of the network is to develop strategies for rapid dissemination of validated protocols so they may be utilized by the entire clinical community. Applicants should propose at least two examples (conducted either concurrently or sequentially) of protocols requiring multi center participation. These are examples which they consider important and which address the objectives of the RFA. The proposals should briefly outline the rationale and background of the proposed studies, eligibility criteria, and baseline and outcome measures. Budget and Related Items All applications must include in their budget, expenses for three planning trips to Bethesda each year. All clinical center applications must include in their budget the costs of any laboratory studies which will not be covered by private payment. Applications for the CRCs and the Biostatistical Support Center should prepare five budget periods of 12 months each. The budget may be increased at three percent annually for each of the successive years. The awards of these budgets will be subjected to administrative review annually. Collaborative Organization The Principal Investigator of each Clinical Research Center and the Principal Investigator of the BSC will meet as an interactive committee three times in each year of the study. Collaborative protocols will be developed by this committee. Data will be submitted centrally to the BSC. SPECIAL INSTRUCTIONS FOR INCLUSION OF MINORITIES IN CLINICAL RESEARCH STUDIES For projects involving clinical research, the NIH requires applicants to give special attention to the inclusion of women and minorities in study populations. For this application, no comment is necessary regarding inclusion of women. However, if minorities are not included in the study population, specific justification must be provided. Applications must address procedures that will be used to recruit and maintain minority population members into the study, the specific minority population that will be accessible for inclusion in the study, and the approximate percent of minority population that it is anticipated can be recruited. LETTER OF INTENT Prospective applicants are asked to submit, by March 17, 1997, a letter of intent that includes a descriptive title of the proposed research, the name, address, and telephone number of the Principal Investigator, the identities of other key personnel and participating institutions, and the number and title of the RFA in response to which the application may be submitted. Although a letter of intent is not required, is not binding, and does not enter into the review of subsequent applications, the information that it contains is helpful in planning for the review of applications. It allows NIDDK staff to estimate potential review workload and to avoid conflict of interest in the review. The letter of intent is to be sent to: Chief, Review Branch Division of Extramural Activities National Institute of Diabetes and Digestive and Kidney Diseases 45 Center Drive, Room 6AS-37F2 - MSC 6600 Bethesda, MD 20892-6600 Telephone: (301) 594-8885 FAX: (301) 480-3505 Email: HaganA@ep.niddk.nih.gov APPLICATION PROCEDURES The research grant application from PHS 398 (rev. 5/95) is to be used in applying for these grants. These forms are available at most institutional offices for sponsored research and from the Division of Extramural Outreach and Information Resources, National Institutes of Health, 6701 Rockledge Drive, MSC-7910, Bethesda, MD 20892-7910, telephone 301-710-0267, email: asknih@odrockm1.od.nih.gov. The RFA label available in the PHS 398 (rev. 5/95) must be affixed to the bottom of the face page of the application. Failure to use this label could result in delayed processing of the application such that it may not reach the review committee on time for review. In addition, the RFA title and number must be typed of line 2 of the face page of the application form and the YES box must be marked. Submit a signed, typewritten original of the application, including the Checklist, and three signed photocopies, in one package to: DIVISION OF RESEARCH GRANTS NATIONAL INSTITUTES OF HEALTH 6701 ROCKLEDGE DRIVE, ROOM 1040 - MSC 7710 BETHESDA, MD 20892-7710 BETHESDA, MD 20817 (for express/courier service) At the time of submission, two additional copies of the application must be sent to: Chief, Review Branch Division of Extramural Activities National Institute of Diabetes and Digestive and Kidney Diseases 45 Center Drive, Room 6AS-37F - MSC 6600 Bethesda, MD 20892-6600 Applications must be received by April 17, 1997. If an application is received after this date it will be returned to the applicant without review. The Division of Research grants (DRG) will not accept any application in response to this RFA that is essentially the same as one currently pending initial review unless the applicant withdraws the pending application. The DRG will not accept any application that is essentially the same as one already reviewed. REVIEW CONSIDERATIONS Applications that are complete and responsive to the RFA will be evaluated for scientific and technical merit by an appropriate peer review group convened by the NIDDK in accordance with NIH peer review procedures. As part of the initial merit review, all applications will receive a written critique and undergo a process in which only those applications deemed to have the highest scientific merit will be discussed, assigned a priority score, and receive a second level review by the National Diabetes and Digestive and Kidney Disease Advisory Council. Applicants are encouraged to submit and describe their own ideas on how best to meet the goals of the study. Applications will be judged primarily on the scientific quality of the application. Although the technical merit of the protocol is important, it will not be the sole criterion for selection of an application for award. Other considerations such as the importance and timeliness of the proposed studies, access to patients including minority populations, the discussion of considerations relevant to the RFA, expertise of the investigators, their capability to perform the work proposed, and a demonstrated willingness to work as part of the network will be part of the evaluation and funding criteria. The review group will also assess the following: Clinical Centers: o Scientific merit of the proposed studies; o Qualifications, experience, and commitment of key personnel including previous experience in relevant studies; o Viability of plans to recruit an adequate number of patients, including an appropriate representation of minorities; o Facilities, equipment and organizational structure to effectively implement protocols through the network; o Rationale and cost-effectiveness of the research approach proposed. o Appropriateness of the proposed budget. o For foreign applicants: opportunities for furthering research programs through the use of unusual talent resources, populations, or environmental conditions in other countries that are not readily available in the United States or which augment existing U.S. resources Biostatistical Support Center: o Organizational, administrative, and supervisory ability and statistical expertise to serve as a Biostatistical Support Center for the multi center interactive projects; o Qualifications, experience, and commitment of key personnel; o Facilities and equipment to function as a Biostatistical Support Center for an interactive network; o Cost-effectiveness of procedures proposed; o Appropriateness of the budget for the work proposed. AWARD CRITERIA Applications recommended by the NIDDK Advisory Council will be considered for award based upon (a) scientific and technical merit; (b) program balance, sufficient compatibility of features to make a successful collaborative program a reasonable likelihood and the geographic distribution of the participating centers; (c) availability of funds. The anticipated date of award is September 30, 1997. INQUIRIES Inquiries concerning this RFA are strongly encouraged. The opportunity to clarify any issues or questions from potential applicants is welcome. Direct inquiries regarding programmatic issues to: John W. Kusek, Ph.D. or Leroy M. Nyberg, Ph.D., M.D. Division of Kidney, Urologic and Hematologic Diseases National Institute of Diabetes and Digestive and Kidney Diseases 45 Center Drive, MSC 6600 Bethesda, MD 20892-6600 Telephone: (301) 594-7717 FAX: (301) 480-3510 Email: KusekJ@ep.niddk.nih.gov NybergL@ep.niddk.nih.gov Direct inquiries regarding fiscal and administrative matters to: Ms. Trude Hilliard Division of Extramural Activities National Institute of Diabetes and Digestive and Kidney Diseases 45 Center Drive, MSC 6600 Bethesda, MD 20892-6600 Telephone: (301) 594-8859 FAX: (301) 480-3504 Email: HilliardT@ep.niddk.nih.gov AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance No. 93.849. Awards are made under authorization of the Public Health Service Act, Title IV, Part A (Public Law 78-410, as amended by Public Law 99-158, 42 USC 241 and 285) and administered under PHS grants policies and Federal Regulations 42 CFR 52 and 45 CFR Part 74. This program is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. The PHS strongly encourages all grant and contract recipients to provide a smoke-free work place and promote the non-use of all tobacco products. In addition, Public Law 103-227, the Pro-Children Act of 1994, prohibits smoking in certain facilities (or in some cases, any portion of a facility) in which regular or routine education, library, day care, heath care, or early childhood development services are provided to children. This is consistent with the PHS mission to protect and advance the physical and mental health of the American people. .
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