A -- Longitudinal Assessment of Bariatric Surgery (LABS) Clinical Consortium

INTRODUCTION: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) of the National Institutes of Health (NIH) and of the Department of Health and Human Services (DHHS) seeks industry collaborators to participate in coordinated clinical, epidemiological and behavioral studies that will analyze the risks and benefits of bariatric surgery and its impact on the health and well-being of patients with extreme obesity, and identify the kinds of patients who are most likely to benefit. Industry collaborators able to provide clinical expertise in the evaluation, screening, dosing, and follow up of patients at risk for venous thromboembolism following bariatric surgery; and/or evaluate the pathogenesis, genetic factors, and other pre-operative, intra-operative, and post-operative features or factors that are believed to affect the outcomes following bariatric surgery; and/or identify unique methods to evaluate alternate bariatric surgical therapies are sought. A prospective database of adult patients with severe obesity undergoing bariatric surgery will be created by the NIH Longitudinal Assessment of Bariatric Surgery (LABS) Clinical Consortium that will allow the prospective evaluation and longitudinal follow-up of a large group of patients in a standardized fashion. The overall goal of this study is to perform clinical, epidemiological, and mechanisms of action research in patients undergoing bariatric surgery at six clinical sites using a standardized and coordinated approach to their evaluation, operative procedure, and follow up. Ancillary studies to evaluate the pathogenesis, genetic features, and other factors that may affect outcomes after bariatric surgery are also anticipated. It is expected that the following will be participating: six clinical sites at the University of Pittsburgh Medical Center (Pennsylvania), Columbia-Presbyterian Hospital and Cornell University (New York), East Carolina Medical Center (North Carolina), Neuropsychiatric Research Institute (North Dakota), University of California, Davis (California) and the University of Washington (Washington); and a Data Coordinating Center at the Graduate School of Public Health at the University of Pittsburgh. SUMMARY: The National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) of the National Institute of Health (NIH) of the Public Health Service (PHS) of the Department of Health and Human Services is seeking proposals in the form of Capability Statements from companies to enter into a collaborative arrangement to provide clinical expertise in the evaluation, screening, dosing, and follow up of patients at risk for venous thromboembolism following bariatric surgery; and/or identify unique methods to evaluate alternate bariatric surgical therapies. The collaborative arrangements may be either Clinical Trial Agreements or Cooperative Research and Development Agreements (CRADA's). The NIDDK is also seeking proposals from companies for a collaborative arrangement to evaluate the pathogenesis, genetic factors, and other pre-operative, intra-operative, and post-operative features or factors that are believed to affect the outcomes following bariatric surgery. Examples of potential studies include: (a) identification of host biomarkers and/or genetic typing factors associated with the development of severe obesity; (b) exploration of the pharmacokinetics and dosing regimens for prophylaxis of venous thromboembolism in bariatric surgery patients; (c) evaluation of the possible screening tests for pre-existing thromboembolism; and (d) identification of unique methods to evaluate alternate bariatric surgical therapies such as the laparoscopic banding procedure. SUPPLEMENTARY INFORMATION: Collaborative arrangements may be either Clinical Trial Agreements or Cooperative Research and Development Agreements (CRADA's). CRADA's are agreements, pursuant to the Federal Technology Transfer Act of 1986 (FTTA, 15 U.S.C. 3710; and Executive Order 12591 of April 10, 1987, as amended by the National Technology Transfer and Advancement Act of 1995), designed to enable certain collaborations between Government and non-government parties and/or laboratories. Clinical Trial Agreements and CRADA's are neither grants nor contracts for the procurement of goods or services. The NIDDK is prohibited from transferring funds to a collaborator in a Clinical Trial or a CRADA. Under both a Clinical Trial agreement and a CRADA, NIDDK can contribute facilities, staff, materials, and expertise, but not funding, to the collaboration. Under a CRADA a collaborator typically contributes facilities, staff, materials, expertise and funding to the collaboration. The collaborator, under a CRADA, receives an option to negotiate an exclusive or non-exclusive license to Government intellectual property rights arising under the CRADA in a pre-determined field of use. STUDY GOAL: The overall goal of this study is to perform coordinated clinical, epidemiological, and mechanisms of action research in patients undergoing bariatric surgery at six clinical sites using a standardized and coordinated approach to their evaluation, operative procedure, and follow up. In this longitudinal and observational study, a database will be developed on adult patients with severe obesity undergoing bariatric surgery. The relationship of defined pre- and intra- operative factors to post-surgical outcomes such as weight loss, surgical complications, and co-morbidity improvements will be studied. The LABS consortium has an interest in assessing in more detail the pre-operative risk factors, screening tests, and dosing of prophylactic agents used for venous thromboembolism prevention. In addition, the LABS consortium is interested in assessing in more detail other potential factors that affect surgical outcomes. Furthermore, LABS is interested in the possible future study and identification of host genetic factors. OTHER RELEVANT INFORMATION: Whole blood will be collected from participants enrolled in LABS studies. Serum and plasma from participants in the study will be collected. Tissue from liver biopsies may also be available. CAPABILITY STATEMENTS: A Selection Committee will utilize the information provided in the Collaborator Capability Statements received in response to this announcement to help in its deliberations. It is the intention of the NIDDK that all qualified collaborators have the opportunity to provide information to the Selection committee through their capability statements. The Capability Statement should not exceed 10 pages. The Selection Committee will be considering its selection based upon data in the Capability Statement which addresses the following selection criteria below. If no data are available, the potential Collaborator should so indicate. 1. The Capability Statement should provide specific details of the methods and materials to be utilized in the evaluation, screening, dosing, and expertise in following patients at risk for venous thromboembolism, if venous thromboembolism is the subject of the proposal. Potential collaborators should provide evidence for proposed dosing regimens, possible strategies to assess administration of medication, proposed methods for assessing drug levels and pharmacokinetics. 2. The Capability Statement should provide specific details and proof of research expertise in the area of the genetics of obesity, if genetics is the subject of the proposal. 3. The Capability Statement should provide evidence and specific details of expertise in areas related to the pathogenesis of severe obesity and/or the expertise in the area of proposed factors believed to be related to surgical outcomes. 4. The Capability Statement must address willingness to promptly publish research results and ability to be bound by PHS intellectual property policies if a CTA or CRADA is entered (see CRADA: http://ott.od.nih.gov/newpages/crada.pdf ). TERMS: The Collaborator will be expected to execute either a Clinical Trial Agreement or a Cooperative Research and Development Agreement (CRADA). Examples of each can be found at http://techdev.niddk.nih.gov/forms.htm. No funding from the government is available. SUBMISSION DATES: Only written Capability Statements received by the NIDDK on or before September 9, 2005 will be considered. Applicants meeting the criteria set forth in this announcement will be invited at the Applicant's own expense to discuss with the Study Steering Committee their plans, capabilities, and research findings and expertise pertinent to the study at a meeting of the Study's Steering Committee, date to be determined. Submit Capability Statements to: Rochelle Blaustein, J.D. Director, Technology Transfer and Development National Institute of Diabetes and Digestive and Kidney Diseases 12 South Drive, MSC 5632 Bethesda, MD 20892-5632 Telephone: +1 (555) 000-0000 Email: contact@example.gov Fax: +1 (555) 000-0000. For Scientific Inquiries contact: Dr. Carolyn W. Miles, Ph.D. Director, Clinical Obesity and Nutrition Program Division of Digestive Diseases and Nutrition NIDDK National Institutes of Health 6707 Democracy Blvd. Room 665, MSC 5450 Bethesda, Maryland 20892-5450 Telephone: +1 (555) 000-0000 Email: contact@example.gov Fax: +1 (555) 000-0000 For General Inquiries contact: Peter T. DiMauro, Ph.D., Technology Development Specialist NIDDK Office of Technology Transfer and Development 12 South Drive, MSC 5632 Bethesda, MD 20892-5632 Phone +1 (555) 000-0000 FAX 301-402-746 Email: contact@example.gov A formatted version of this Notice of Opportunity will be posted at: http://TechDev.NIDDK.NIH.GOV/LABSPUB.pdf