SOURCES SOUGHT
A -- Action to Control Cardiovascular Risk in Diabetes (ACCORD) Follow-up Study
- Notice Date
- 2/13/2009
- Notice Type
- Sources Sought
- NAICS
- 541712
— Research and Development in the Physical, Engineering, and Life Sciences (except 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-SS-10-07
- Archive Date
- 3/18/2009
- Point of Contact
- Paul C McFarlane,, Phone: 301-435-0345, Cheryl P Jennings,, Phone: (301) 435-0347
- E-Mail Address
-
pmcfarlane@mail.nih.gov, cj19f@nih.gov
- Small Business Set-Aside
- N/A
- Description
- The National Heart, Lung, and Blood Institute (NHLBI), NIH is interested in identifying institutions with the capability to serve as a Coordinating Center (CC) for its Action to Control Cardiovascular Risk in Diabetes (ACCORD) follow-up study. The project title is ACCORDION. ACCORD Trial (Background and Purpose): 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 10,251 participants with type 2 diabetes mellitus conducted in 77 academic, VA, and non-academic clinical sites across the U.S. and Canada. The current infrastructure comprises 7 clinical networks, a Data Coordinating Center, a Central Laboratory, an ECG Reading Center, and a Drug Distribution Center. The trial has been ongoing since September 30, 1999. ACCORD participants had to be adults at high risk for a cardiovascular disease (CVD) event by having clinical CVD, subclinical CVD, or at least 2 additional CVD risk factors in addition to Type 2 diabetes. 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 with standard control (HbA1c 7.0-7.9%), of fibrates to increase HDL-cholesterol and lower triglycerides compared with placebo in the context of good LDL-C control by statins, and of intensive BP control targeting the normal range (SBP< 120 mmHg) compared with standard control (SBP<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). ACCORD includes substudies on the investigation of the effects of diabetes on cognitive functioning and brain magnetic resonance imaging (the MIND substudy); on retinopathy and its progression over time, (the EYE substudy); and a Health Quality of Life and Cost-effectiveness substudy. In February 2008, the intensive glycemia strategy was stopped early after a mean 3.5 years of treatment because of a significant 22% higher all-cause mortality rate compared with the standard strategy group; in contrast, there was a non-statistically significant 10% reduction in the composite primary outcome of nonfatal MI, nonfatal stroke, or CVD death [NEJM 358:2545, 2008]. Intensive group participants were transitioned to the standard treatment strategy until the end of the scheduled follow-up; the BP and lipid trials continue as planned. Due to the unexpected findings from the intensive glycemia strategy results and evidence from other studies that beneficial effects of glucose (and other risk factors) control on CVD risk may take years to develop, it is important to follow the ACCORD participants to examine post-trial patterns and outcomes. The impact of ACCORD on the treatment of patient with type 2 diabetes will continue to expand as analyses of the rich database from the main trial and, importantly, an observational follow up phase, are presented and published. ACCORDION (The ACCORD Follow-Up Study): A 5-year observational ACCORD follow-up (ACCORDION) from April 1, 2010 through March 31, 2015 is planned. During ACCORDION all ACCORD participants would be invited to provide informed consent for continued follow-up measurement. An estimated 92% of the original 10,251 participants are anticipated to be available for follow-up, based on current numbers of deaths, losses-to-follow-up, and refusals. The goal is to have all available ACCORD participants included in ACCORDION, even if the current clinical site is unable to participate. The goal of ACCORDION is to obtain key clinical 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. ACCORDION would have regular 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 specimen analyses, ECGs would be obtained to identify silent myocardial infarctions, and clinical events would be centrally adjudicated. A specific protocol will be developed upon award. It is anticipated that other Agencies or NIH Institutes currently supporting ACCORD substudies will continue supporting the continuation of those substudies in ACCORDION, as an observational follow-up for those substudies would also contribute important clinical information for the treatment of patients with Type 2 diabetes. Potential Offerors for the Coordinating Center award should demonstrate experience and expertise in the following areas: 1.Providing leadership to obtain a high level of retention and high-quality accurate measurement of key clinical variables in 10,000 study participants at over 70 sites across the United States and Canada. 2.Initiating the observational follow-up study in a timely manner to minimize participant loss 3.Ability to transfer all data from the previous coordinating center while maintaining quality, confidentiality, and security of the files from the main trial and all substudies 4.Providing leadership for investigators to develop the protocol, manual of procedures, and Informed Consent development and obtaining approval of protocol and Informed Consent by the Coordinating Center’s IRB 5.Establishing working, administrative, regulatory, and financial relationships with approximately 70 clinical sites. Negotiating and contracting with clinical sites for participant retention and data collection. 6.Designing and implementing a follow-up plan for participants at clinical sites that decide not to participate in ACCORDION. 7.Soliciting and overseeing a central laboratory and ECG reading center, including adding data from these central sites into the main database. 8.Maintaining quality control and monitoring of the performance and regulatory status of the clinical sites. Included are coordinating and assuring high quality of the following: telephone collection of key outcome data by clinic staff, in person collection of key clinical data by clinic staff, and obtaining medical records when clinical events have occurred. 9.Designing and implementing a central adjudication process for confirmation of clinical cardiovascular events. 10.Coordinating, arranging, participating in, and providing information necessary for regular Steering Committee, Observation Study Monitoring Board, training and other necessary study meetings; 11.Developing and maintaining a web-based distributed data entry system for the trial, the follow-up study, and sub-studies. This includes developing data collection instruments and assuring security and confidentiality of study data entered into the system. 12.Establishing and maintaining a database in multiple areas relevant to diabetes and cardiovascular disease, including glycemia, blood pressure, and blood lipids, and related medications, adverse events, and clinical outcomes. 13.Defining clinically relevant variables in a large clinical-trial and epidemiology dataset addressing Type 2 diabetes and cardiovascular disease, including 10,000 participants seen over an average of 8 years of follow-up. This includes defining variables in the areas of glycemia, blood pressure, and blood lipids, including data relevant to randomization assignment, clinical treatments (including medications), adverse events, and clinical outcomes for these topics. 14.Providing statistical leadership in defining research questions relevant to diabetes and cardiovascular disease to be explored by analyzing the dataset. Conducting state-of-the art analyses of a large, longitudinal dataset from a clinical trial of 10,000 participants that includes an observational follow-up period for a total of about 8 years of follow-up data after randomization. This activity includes intention-to-treat analyses of clinical trial and follow-up data as well as examination of epidemiologic relationships using time-dependent covariates and properly adjusting for confounding. Interpreting findings from these analyses in a clinically relevant manner. 15.Providing technical reports as required by the Government, which is at least annually, but may be as frequent as quarterly, and at study completion. This is not a request for proposals (RFP) and the Government is not committed to award a contract pursuant to this announcement. Any business concern, regardless of size that possesses the capabilities necessary to undertake this requirement may submit documentation of their capabilities to the Contracting Officer at the address below. Include the name, address, telephone number, and e-mail address of a point of contact. When submitting this information, please reference the notice number above. We ask that the capabilities statement not exceed 14 single sided or 7 double-sided pages in length. Do not include budget information. An original and two (2) copies of the capabilities statement must be submitted. Electronic submissions are acceptable and may be sent to the following e-mail address: pm24v@nih.gov. The due date is Tuesday, March 3, 2009 at 3 PM local time (Bethesda, MD). Paul D. McFarlane, Contracting Officer, Office of Acquisitions, DERA National Heart, Lung, and Blood Institute, NIH, DHHS 6701 Rockledge Drive, Two Rockledge Centre, Room 6126-A, MSC 7902 Bethesda, MD 20892-7902 For overnight deliveries use zip code 20817, no MSC is required. The capabilities statement shall include: 1.The total number of employees and any relevant NAICS codes of the business concern 2.The expertise, experience, and professional qualifications of professional, technical, and administrative personnel in accordance with the above requirements. 3.A description of general and specific facilities and equipment available, including computer equipment and software 4.An outline of any projects of similar size, scope, and complexity in which the business concern and the proposed personnel have participated; and 5.Any other information considered relevant to this program. The following criteria will be used to evaluate the capability statements. These criteria are weighted equally. 1.PERSONNEL AND EXPERIENCE: Adequacy, appropriateness and relevance of the experience, and expertise of the professional, technical, and administrative staff to develop and implement an observational long-term follow-up study of a large, complex, multicenter, factorial randomized trial evaluating the long-term effects of different medical treatment strategies on cardiovascular disease in people with Type 2 DM. The experience and expertise should be on projects of similar size, scope, and complexity. 2.ORGANIZATIONAL EXPERIENCE AND FACILITIES: Adequacy and availability of the organizational and administrative structure to develop and implement a large, multisite observational follow-up study with the organizational commitment to the program. Successful prior experience with transferring from another coordinating center an almost completed large multicenter CV trial to initiate an observational follow-up study, which includes timely recruitment and retention of sites and subjects from the previous trial with the possibility of the coordinating center having to be a site for subjects from clinical sites that are not participating in the follow-up trial. Also, prior successful participation by the organization in multicenter observational follow-up trials of similar complexity, both in the collection of data from multiple clinical sites, as well as experience in monitoring the quality and timeliness of such data. Availability and adequacy of the facilities and resources necessary for conducting study coordination, data management and analysis, including computer hardware, software, and other equipment in order to successfully implement the requirements of the contract.
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