PRESOL | A | Support of clinical research in the diagnosis and treatment of tuberculosis (TB)

FBO DAILY ISSUE OF OCTOBER 12, 2008 FBO #2512
SOLICITATION NOTICE

A -- Support of clinical research in the diagnosis and treatment of tuberculosis (TB)

Notice Date: 10/10/2008
Notice Type: Presolicitation
NAICS: 541711 — Research and Development in Biotechnology
Contracting Office: Department of Health and Human Services, Centers for Disease Control and Prevention, Procurement and Grants Office (Atlanta), 2920 Brandywine Road, Room 3000, Atlanta, Georgia, 30341-4146
ZIP Code: 30341-4146
Solicitation Number: TBTC-Presolicitation
Point of Contact: Rafael A. Aviles, Phone: 770-488-2805
E-Mail Address: raviles@cdc.gov
Small Business Set-Aside: N/A
Description: The Centers for Disease Control and Prevention Coordinating Center for Infectious Diseases (CCID) wishes to inform and solicit input from Industry and potential offerors regarding the attached draft Statement of Work (SOW) for the support of clinical trials and research for the diagnosis and treatment of tuberculosis (TB Trials Consortium). Detailed requirements and instructions will be provided through a formal solicitation. A formal solicitation has not yet been developed, however, a solicitation is planned for release during fiscal year 2009. Between 6-12 contracts are anticipated to be awarded. Questions and comments to the draft SOW shall be submitted via E-mail to Mr. Ralph Aviles at raviles@cdc.gov no later than October 22, 2008. Responses to questions received in response to the draft SOW and the pre-solicitation conference will be posted on the Federal Business Opportunities (FBO) website (www.fbo.gov) no later than November 7, 2008. A Pre-Solicitation Conference will be held on November 13, 2008, from 8:30AM to 10:30AM at The Westin Peachtree Plaza Hotel, 210 Peachtree Street, Atlanta, GA 30303 ((404) 659-1400 (Hotel), (404) 589-7424 (Fax)) and will consist of a briefing that will include an overview of the requirement presented by CCID and an overview of the procurement process presented by the Procurement and Grants Office. A teleconference option will be made available for the first 100 registrants for those unable to be physically present. The teleconference information will be provided upon registration. All participants must register in order to attend. Questions may be posed during the Pre-Solicitation Conference and additional questions maybe asked via e-mail up to November 17, 2008. Written responses to the questions posed at the Pre-Solicitation Conference or later will be posted on the FBO website no later than December 2, 2008. Questions not submitted at the Pre-Solicitation Conference can be submitted via E-mail to Mr. Ralph Aviles at raviles@cdc.gov and Mr. Victor Tomlinson at vtomlinson@cdc.gov. Interested institutions and companies must register no later than close of business Monday, November 5, 2008. Registration requests should be sent via E-mail to Mr. Ralph Aviles at raviles@cdc.gov. Your registration request should include the company or institution name, contact person, address, phone number, fax number, e-mail address and the names of the representatives planning to attend. Attendance is not mandatory and will not affect your eligibility to submit an offer in a future solicitation. This announcement is for information and planning purposes and does not constitute an Request For Proposal and is not construed as a commitment by the Government. FAR 15.201, encourages early exchanges with industry and potential offerors to improve the understanding of the Government requirements and industry capabilities, thereby allowing potential offerors to judge whether they can satisfy the governments requirement. Final Draft Version of Statement of Work A. Project Identification & Purpose The purpose of this contract is to support clinical research in the diagnosis and treatment of tuberculosis (TB). The contractor(s) shall conduct all phases (screening, enrollment, treatment, and follow-up) of clinical trials in patients with TB disease and, if applicable, latent TB infection, including observation, treatment, data collection and follow-up after therapy. The scope of activities will range from conducting small laboratory-based studies to large Phase 2 and long-term Phase 3 clinical trials to evaluate new TB drugs, diagnostics, and treatment regimens. The contractor(s) shall also participate fully as a member of the TB Trials Consortium (TBTC). A description of the TBTC and a copy of the TBTC By-Laws are provided as Attachments in Section J. B. Background and Need The resurgence of tuberculosis from 1986-1992 in the United States served to remind the nation of the continuing threat posed by this disease. In response, national plans for TB control and elimination were developed. These included the "Strategic Plan for the Elimination of Tuberculosis," adopted by the Advisory Council on the Elimination of Tuberculosis, the "National Action Plan to Combat Multidrug-Resistant Tuberculosis," and the Institute of Medicine's (IOM) Report "Ending Neglect." All call for the development of new drugs and drug delivery systems for the treatment of tuberculosis and tuberculosis infection, and for the evaluation of different combinations and intervals of administration of new and existing drugs. The Centers for Disease Control and Prevention (CDC) has historically placed a high priority on the field evaluation of new drugs and drug regimens, new delivery systems, and new diagnostic tests in multicenter trials, to determine their effectiveness under program conditions. The clinical trial evaluation of new treatments for TB must be conducted in different areas of the world to ensure that adequate numbers of patients are studied and to assure applicability of findings among diverse racial and ethnic populations affected with TB. Discovery of findings applicable to management of TB disease in children, in pregnant woman and in persons living with HIV/AIDS are also goals of the TBTC. Recognizing that a network of investigators with access to large numbers of patients with tuberculosis or tuberculous infection is necessary for the rapid and timely implementation of investigative protocols, CDC's Division of TB Elimination (DTBE) funded and established the TB Trials Consortium (TBTC). The current TBTC is a group of >25 clinical study sites (health departments and academic medical centers) that are funded by CDC via individual contracts, or through a Memorandum of Understanding (MOU) with the Veterans Administration Medical Center in Washington D.C., to perform studies of TB treatment. The TBTC also conducts studies of pharmacokinetics, pharmacodynamics and drug-drug interactions involving anti-TB drugs. Examples of past and current TBTC protocols (including Study 29 and Study 29 PK, the TBTC's newest studies), are included as Attachments in Section J. C. Statement of Work CDC and the current TBTC investigators have together developed an infrastructure and methods of operation that fully engage the capacities of the clinical sites. The current infrastructure of the TBTC includes: • a network of clinical sites in the US, Canada, Brazil, Uganda, South Africa and Spain. The North American sites are health departments or academic medical centers under contract with CDC, or are funded via the Memorandum of Understanding mechanism administered by the Veterans Administration Medical Center in Washington DC. The study sites in Brazil, Uganda, South Africa and Spain are funded through subcontracts that have been established by academic medical centers in North America on behalf of, and with funding from, the CDC; • a formal set of By-Laws which govern the function of the consortium, and which define a network of committees, protocol teams and working groups to facilitate the accomplishment of the consortium's objectives; • a communications system of e-mail, telephone conferences, web-conferences, online transfer of data, and semi-annual in-person meetings; • cooperative relationships with local TB control programs at each site, which facilitate the recruitment and management of trial patients; • an expert Data & Safety Monitoring Board which convenes approximately annually to review ongoing clinical trials; • coordination with and between the CDC IRB (ethical review committee) and IRB's from the clinical sites; • a Data and Coordinating Center at CDC. The DTBE-CDC functions as the Data and Coordinating Center (DCC) for the TBTC. A DTBE-CDC project officer is designated for each clinical study. The DTBE-CDC Project Officer, the designated DTBE-CDC contractor, and the study statisticians have access to all data collected for TBTC studies, and review data as recorded on the case report forms or in the central database; • Web-based 24/7 enrollment capacity, and a continuous, real-time data quality assurance program; • cooperative relationships with key manufacturers of TB and anti-HIV drugs, and with key public-private partnerships, non-governmental organizations, and international agencies; • cooperative relationships with mycobacteriology, pharmacology, pharmacokinetic and genetics laboratories within CDC and worldwide; • cooperative relationships with the U.S. Food and Drug Administration and the U.S. National Institutes of Health; • an expert contract research organization (CRO) which performs clinical site monitoring and provides a variety of other support functions; • collaborative relationships with a variety of relevant global experts in TB clinical trials, medical statistics, pharmacology, animal modeling, basic mycobacteriologic science, and other domains. As noted above, several executive committees-composed of site investigators, study coordinators, and DTBE-CDC staff-conduct the administrative and development work of the TBTC. These committees include: I. the Core Science Group (CSG), which develops and oversees implementation of the TBTC's scientific research agenda; II. the Implementation and Quality Committee (IQC), which supervises the conduct and quality assurance of ongoing studies, and assures the feasibility of proposed new studies; III. the Publications and Presentations Committee (P&P), which directs the manner in which results of TBTC studies are made public; IV. the Advocacy and External Relations Committee (AER), which manages TBTC's relationships with outside institutions and entities; and, V. the Executive Affairs Group (EAG), which is composed of TBTC leadership (including chairs of other major committees) and which serves as the executive arm of TBTC. The TBTC By-Laws codify this committee structure. C.1 Contract Requirements Each contractor shall, as an independent organization and not as an agent of the Government, furnish all the necessary services, qualified personnel, material, equipment, and facilities to concurrently perform multiple studies and/or clinical trials for the treatment of active and/or latent tuberculosis (TB) and for the evaluation of new tests or approaches for the diagnosis of TB infection and disease, using procedures outlined in each study's applicable protocol. At the study sites, data must be available for external checking against the original source documentation as required by U.S. federal regulations. Either DTBE-CDC staff or an external Clinical Site Monitoring Contractor will evaluate good clinical practice, data collection and reporting, regulatory compliance, accurate protocol implementation, internal quality management, and test product accountability. Site visits will be performed approximately twice a year, or as needed to review selected protocols, provide training on protocol conduct, review internal quality assurance plans, and document error resolution. The expected duration of these contracts is ten (10) years. During the next decade, the focus of the consortium will initially be on therapy of active TB disease. Studies involving latent TB infection (LTBI) may be undertaken at future times if judged of sufficiently high priority and recommended by CSG, approved by the TBTC Steering Committee, and supported by DTBE. Specific contract requirements include the following: a. Participation in clinical research studies each year. The contractor shall: 1. Recruit, screen, consent, enroll, treat, and follow patients for TB studies. The patient population shall reflect the demographics of the local community, and shall include minorities and women. Expected enrollment is based upon WHO reported or estimated incidence. The contractor, if based in an area of low TB incidence (<20 cases per 100,000), shall enroll a minimum of 10 newly diagnosed active tuberculosis patients each year over all actively enrolling TB treatment protocols. Contractors based in areas of medium TB incidence (21-100 cases per 100,000) shall enroll a minimum of 30-50 newly diagnosed active tuberculosis patients each year over all actively enrolling TB treatment protocols. Contractors based in areas of high TB incidence (>100 cases per 100,000) shall enroll a minimum of 100 newly diagnosed active tuberculosis patients each year over all actively enrolling TB treatment protocols. 2. Retain, and follow to completion of study, patients enrolled in TB trials and studies. 3. Conduct research studies and/or clinical trials in accordance with each study's applicable protocol. In general, these studies will follow the procedures detailed in each protocol with regard to scheduled clinic visits, required laboratory tests (performed in qualified laboratories), required chest x-rays, and appropriate data collection forms to be used for reporting results. When required by individual protocols, the contractor shall be responsible for shipping of specimens to designated laboratories or repositories. 4. Conduct and report on studies according to accepted Good Clinical Practice and in compliance with existing U.S. Federal Regulations (including CDC, U.S. Food and Drug Administration, and the Office of Human Research Protections [OHRP]) and applicable national policies concerning use of investigational agents and protection of human subjects. Because these studies will be funded by the U.S. government, they must comply with regulatory requirements of both the host country and the United States. 5. Report adverse experiences of patients in clinical trials according to specific protocols, and in compliance with applicable national and U.S. regulatory requirements. 6. Collect and report data according to the requirements of the specific protocol. Each site shall provide copies of completed patient data forms to the CDC Project Officer by a mutually agreed mechanism, and at intervals determined by the protocol (within 30 days of event unless otherwise specified). 7. Respond to data queries and requests from the Data & Coordinating Center at CDC. 8. Participate in as many active TBTC protocols as is feasible at the site, considering availability of TB patients and staff capacity. 9. Assure laboratory capacity and performance required by study protocols; 10. Send required administrative reports to DTBE-CDC by a mutually agreed upon mechanism and schedule; b. Full participation as a member of the TB Trials Consortium (TBTC) Throughout the duration of the contract, the contractor shall participate fully as a member of the TB Trials Consortium (TBTC), as specified in the TBTC By-Laws (provided as an Attachment in Section J). The contractor shall abide by these By-Laws. In particular, as an active member of the TBTC, the contractor shall: 1. as a responsible member of the Steering Committee, participate in efforts to develop, implement, monitor, and update the TBTC research agenda; 2. adhere to the policies, procedures, and By-Laws that guide all aspects of the TBTC's activities, and operations; 3. participate as appropriate in protocol development;. 4. participate actively and as appropriate in TBTC committee activities; 5. participate fully in TBTC quality assurance activities; 6. cooperate with the TBTC clinical site-monitoring program 7. abide by the TBTC policies and procedures for the publication of data included in the TBTC By-Laws; 8. participate in TBTC conference phone calls and e-mail communications, and attend two TBTC meetings per year; 9. accept and abide by any Conflict of Interest policy included in the TBTC By- Laws; and, 10. interact with local TB and HIV Control Programs to integrate and complement their respective work and research agendas. C. Special considerations for clinical study sites located outside of the U.S. and Canada Offerors whose proposal includes the enrollment of patients who reside outside of the United States or Canada can propose to become a TBTC site in one of three ways: Option (1) - the offeror may be a U.S. or Canadian institution that proposes to sub-contract with institutions outside of these two countries on behalf of the U.S. government (CDC), with the purpose of conducting clinical trials for treatment or prevention of TB. In this instance, the offeror's proposal will include a subcontractual arrangement with an institution outside of the U.S. and Canada. The international, sub-contracted institution would be chosen to provide access to a larger population of potential trial participants (persons with TB disease or infection) than would be available at the institution of the primary offeror. This arrangement will provide for close coordination between the two institutions. Under Option 1, the US/Canadian institution will provide: -expertise in clinical trials, in Good Clinical Practice, in Good Laboratory Practice, and in human subjects protections, and - experience in the management of research contracts with U.S. government agencies (such as the Centers for Disease Control and Prevention), experience in compliance with regulatory requirements applicable to clinical trials, and experience in sub-contracting procedures. Under Option 1, the international institution will provide: - access to a large population of TB patients, - expertise in the implementation of research in their own national setting, and - the large majority of the skilled staff necessary to implement the trials. Such arrangements serve typically to build or strengthen capacity in both of the partners. Option (2) - the offeror may be a non-U.S., non-Canadian institution eligible to receive funds (and institute research activities) directly from (and for) a U.S. government agency. In this instance, the offeror should submit a proposal that is inclusive of all required elements, and the contract would be executed directly and solely with the non-U.S., non-Canadian institution. Non-U.S., non-Canadian ("international") offerors opting for this approach are expected to be institutions with substantial and well-documented experience in the conduct of clinical trials, significant experience in tuberculosis research, significant prior successful experience in receiving and responding to clinical research funding, and experienced administrative staff familiar with U.S. government contracting procedures. Option (3) - the offeror may be a qualified international institution which elects to obtain supporting services and expertise from a U.S. or Canadian institution through the mechanism of a subcontract. As in option #2 above, the offeror must be a non-U.S., non-Canadian institution eligible to receive funds (and institute research activities) directly from (and for) a U.S. government agency. And as in option #2 above, in this approach, the international institution/offeror is expected to demonstrate (i) substantial and well-documented experience in the conduct of clinical trials, (ii) significant experience in tuberculosis research, (iii) significant prior successful experience in receiving and responding to U.S. clinical research funding, and (iv) the availability of experienced administrative staff familiar with U.S. government contracting procedures. The difference from Option #2 is that in this approach, the offeror proposes to obtain some portion of items i-iv through a subcontract with an institution that can provide or strengthen any of these elements. An offeror applying under option #3 must be fully qualified to accomplish administrative aspects of the contract and sub-contract, and should be of sufficient technical strength that it could reasonably be expected to manage its own technical support services. In each of these 3 approaches, the offeror (with its subcontractors, if any) should demonstrate (a) the availability of patients to enroll, (b) the availability of significant technical strengths in the implementation of TB clinical trials, and (c) the availability of all necessary administrative and regulatory expertise to fulfill the requirements and objectives of this contract. C.2 Contract Phases This contract will be performed in 10 annual phases of 12 months each as follows: PHASE 1: The contractor shall perform start-up/preparation activities in accordance with the procedures and guidelines outlined in detail in the enclosed example of a Phase 2 clinical trial, a Phase 3 clinical trial, and/or a pharmacokinetic protocol. Examples of protocols for TBTC Studies are provided as Attachments in Section J. Enrollment into a study may not begin until the relevant ethical committees or Institutional Review Boards (IRBs) have granted approval (it is recognized that new sites often require somewhat longer time periods to obtain ethical/IRB approvals for the first studies undertaken as part of a new activity). The contractor shall participate fully as a member of the TB Trials Consortium as described above. This will include, during this and all subsequent phases, attendance at semi-annual investigators' meetings. The purpose of these meetings is to review progress and implementation of current trials, to learn from outside experts, and to discuss possible new studies. These meetings will be held twice a year, one in Atlanta GA near CDC in October or November, and one in May in an external location (which may be the site of the annual American Thoracic Society Conference, or may be a different U.S. or foreign site). PHASE 2: The contractor shall start or continue the enrollment, treatment, follow-up, observation, data collection, and data analysis of patients for the studies chosen to be implemented in Phase 1. The Government estimates that 0-4 new studies may be initiated during this phase. The contractor shall participate fully as a member of the TB Trials Consortium as described above. PHASE 3: The contractor shall start or continue the enrollment, treatment, follow-up, observation, data collection, and data analysis of patients for new studies or for the studies that remain active from previous phases. The Government estimates that 0-4 new studies may be initiated during this phase. The contractor shall participate fully as a member of the TB Trials Consortium as described above. PHASE 4: The contractor shall start or continue the enrollment, treatment, follow-up, observation, data collection, and data analysis of patients for new studies or for the studies that remain active from previous phases. The Government estimates that 0-4 new studies may be initiated during this phase. The contractor shall participate fully as a member of the TB Trials Consortium as described above. PHASE 5: The contractor shall start or continue the enrollment, treatment, follow-up, observation, data collection, and data analysis of patients for new studies or for the studies that remain active from previous phases. The Government estimates that 0-4 new studies may be initiated during this phase. The contractor shall participate fully as a member of the TB Trials Consortium as described above. PHASE 6: The contractor shall start or continue the enrollment, treatment, follow-up, observation, data collection, and data analysis of patients for new studies or for the studies that remain active from previous phases. The Government estimates that 0-4 new studies may be initiated during this phase. The contractor shall participate fully as a member of the TB Trials Consortium as described above. PHASE 7: The contractor shall start or continue the enrollment, treatment, follow-up, observation, data collection, and data analysis of patients for new studies or for the studies that remain active from previous phases. The Government estimates that 0-4 new studies may be initiated during this phase. The contractor shall participate fully as a member of the TB Trials Consortium as described above. PHASE 8: The contractor shall start or continue the enrollment, treatment, follow-up, observation, data collection, and data analysis of patients for new studies or for the studies that remain active from previous phases. The Government estimates that 0-4 new studies may be initiated during this phase. The contractor shall participate fully as a member of the TB Trials Consortium as described above. PHASE 9: The contractor shall start or continue the enrollment, treatment, follow-up, observation, data collection, and data analysis of patients for new studies or for the studies that remain active from previous phases. The Government estimates that 0-4 new studies may be initiated during this phase. The contractor shall participate fully as a member of the TB Trials Consortium as described above. PHASE 10: The contractor shall start or continue the enrollment, treatment, follow-up, observation, data collection, and data analysis of patients for new studies or for the studies that remain active from previous phases. The Government estimates that 0-4 new studies may be initiated during this phase. The contractor shall participate fully as a member of the TB Trials Consortium as described above.
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Place of Performance: Address: Atlanta, Georgia, 30341, United States; Zip Code: 30341
Record: SN01690992-W 20081012/081010214809-db4d18763c91dc2696eb674e31504e25 (fbodaily.com)
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A -- Support of clinical research in the diagnosis and treatment of tuberculosis (TB)