SOLICITATION NOTICE
A -- Action to Control Cardiovascular Risk in Diabetes (ACCORD) Follow-On Study
- Notice Date
- 2/12/2010
- Notice Type
- Presolicitation
- NAICS
- 541711
— Research and Development in Biotechnology
- Contracting Office
- Department of Health and Human Services, National Institutes of Health, National Heart, Lung and Blood Institute, Rockledge Dr. Bethesda, MD, Office of Acquisitions, 6701 Rockledge Dr RKL2/6100 MSC 7902, Bethesda, Maryland, 20892-7902
- ZIP Code
- 20892-7902
- Solicitation Number
- NIH-NHLBI-HC-15A-10-07
- Point of Contact
- Cheryl A Jennings, Phone: (301) 435-0347
- E-Mail Address
-
cj19f@nih.gov
(cj19f@nih.gov)
- Small Business Set-Aside
- N/A
- Description
- The National Heart, Lung, and Blood Institute (NHLBI), NIH intends to negotiate on a non-competitive, sole source basis with Wake Forest University, the Coordinating Center for the Action to control Cardiovascular Risk in Diabetes (ACCORD) to award a Follow-On Study. The cited authority is 41 U.S.C. 252(c)(1), as set forth in FAR 6.302-1. This effort will be a five-year follow-up of the ACCORD clinical trial participants. This contractor has been involved in the recruitment, treatment strategies, follow-up, collection and analysis of data, and reporting of results on 10,251 participants from seven clinical networks across the United States and Canada. The incumbent contractor has the unique capability to provide these required services to NHLBI for the follow-up of the study. Inherent duplication of cost to the Government and unacceptable delays in completing the project make competition unfeasible for this study. The objectives of the study are detailed below. Background and Purpose of the ACCORD Trial: About 24 million people (almost 8% of the U.S. population) have diabetes, which costs the nation an estimated $174 billion annually. People with type 2 diabetes have 2-4 times the rate of major cardiovascular disease (CVD) events compared to those without diabetes. With increasing diabetes rates in the nation, the attributable risk of CVD due to diabetes is increasing. The goal of the ACCORD trial is to address this public health challenge by testing three complementary medical treatment strategies to enhance the options for reducing CVD rates in people with diabetes. ACCORD is a randomized, multicenter, factorially designed clinical trial in 10, 000 participants with type 2 diabetes mellitus conducted in 77 clinical sites across the U.S. and Canada. The current infrastructure comprises 7 clinical networks, one coordinating center, a central laboratory, an ECG reading center, and a Drug Distribution Center. The trial has been ongoing since September 30, 1999. Wake Forest has been the coordinating center since then. The trial was designed to test the effects on major CVD events of a therapeutic strategy to control glycemia to near-normal levels (target HbA1c < 6%) compared to a standard strategy (target HbA1c between 6% and 7%), of fibrates added to statins (compared to statins alone) to increase HDL-cholesterol and lower triglycerides in the context of good LDL-C control, and of intensive BP control targeting the normal range (SBP< 120 mmHg) compared to a standard BP control strategy (SBP between 130 and 140 mmHg). All 10,251 participants are in the glycemia trial; 5,518 are in the lipid trial and 4,733 are in the BP trial. The primary outcome for all 3 trials is first occurrence of a major CVD event (nonfatal MI, nonfatal stroke, or CVD death). The trial included substudies on the investigation of the effects of the treatment strategies on cognition (the MIND substudy); on retinopathy and its progression over time (the EYE substudy); and the Health Quality of Life substudy. Each of these substudies involved substantial fractions of the overall ACCORD study participants. The recruitment phase was completed September 30, 2005 when the study surpassed their goal of 10,000 participants and recruited 10,251 participants. In February, 2008, the ACCORD Glycemia protocol was modified due to safety concerns. All participants in the intensive Glycemia intervention arm were transitioned into the standard Glycemia treatment arm. The protocol remained otherwise unchanged with follow up continuing as planned until June 30, 2009. After June 30, 2009 all patients who give consent will have telephone only follow-up visits every six months (up to December 31, 2010) to assess the occurrence of major cardiovascular events ACCORD Follow-On Study Objectives: A 5-year observational ACCORD follow-on study is anticipated from September 30, 2010 through September 29, 2015. During this time, all ACCORD participants will be invited to provide informed consent for continued follow-up measurements. An estimated 92% of the original 10,251 participants is anticipated to be available for follow-up, based on current numbers of deaths, losses-to-follow-up, and refusals. The follow-on will determine whether differences seen during the study in mortality, CVD events, and microvascular diseases persist or change over time and whether other differences emerge. The goals of the follow-up phase is to obtain key clinical, biological and ECG data that are similar in quality to those obtained during the trial period to enable examination of trends over time. Examining morbidity and mortality from both macrovascular and microvascular diseases will provide a complete picture regarding long-term vascular outcomes from diabetes and the impact of glucose, blood pressure lowering, and lipid treatment on those outcomes. The follow-on phase will consist of periodic clinic visits for data collection and interim phone contacts to obtain information about clinical events. Clinic visits would use streamlined approaches from current methods to obtain key clinically-relevant data that are the most important measures for the glycemia, BP, and lipid trials. Information to be collected would be detailed by investigators but is envisioned as including the following: BP; medications; blood for HbA1c, fasting blood glucose, lipids, and creatinine; and urine for creatinine and albumin. As currently, a central laboratory would conduct biological specimen analyses. ECGs would be obtained to identify silent myocardial infarctions, and clinical events would be adjudicated. A specific protocol will be developed upon award. It is anticipated that the National Eye Institute will continue funding an Eye substudy and that the National Institute on Aging will continue a cognitive substudy, and that the CDC will continue a Health Related Quality of Life substudy, as these substudies provide important clinical information. The Coordinating Center’s expected responsibilities that will continue during the follow on phase include (but are not limited to) all data management and analysis activities including the documentation and maintenance of appropriate confidentiality and security of files for the study and substudies; lead the development of the protocol and manuals of procedures development; monitor the regulatory aspects of the study; establish standardized quality of data gathering; continue to maintain a morbidity/mortality monitoring and adjudication system; maintain quality control and monitoring of the performance status of the clinical sites; solicit and monitor core laboratories such as central ECG and chemistry laboratory; coordinate, arrange, participate in, and provide any information necessary for regular Steering Committee, Observations Study Monitoring Board, training and other necessary study meetings; and provide technical reports as required by the Government (up to one quarterly and a final). The contract will require an extensive comparison of the ongoing clinical trial study, which will cover the activities above. We anticipate subcontracting opportunities during the course of this contract. For instance, there will be a need to establish an ECG Reading Center and a Laboratory Center. This notice of intent expires 15-days from its posting. This is not a request for proposals (RFP). The estimated award date is December 1, 2010. All responsible sources may submit written capability statements demonstrating their ability to perform this research effort on the same study participants. Any interested parties in this or potential subcontracting opportunities may contact, Cheryl A. Jennings, Contracting Officer, cj19f@nih.gov, 301-435-0347.
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