Added: May 08, 2008 4:12 pm
The Food and Drug Administration is seeking a contractor for Analgesic Clinical Trials Project (ACTP): Methods for Combined Analysis of Pain and Analgesic Rescue Scores
REQUEST FOR QUOTE (RFQ). This announcement constitutes the only solicitation and a written solicitation will not be issued.
Requirements:
In March of 2004, the U.S. Food and Drug Administration (FDA) released a white paper entitled "Innovation or Stagnation: Challenge and Opportunity on the Critical Path to New Medical Products. This report called for research to develop and validate new tools and methods for testing new medicines on the "critical path" from the laboratory to the patients. This initiative is called the Critical Path Initiative.
FDA s Critical Path Initiative (CPI) seeks to identify and address scientific and technical obstacles to the optimum development of safe and therapeutically important medical products. Under the CPI, FDA is trying to identify innovative ways to enhance drug development and reduce the time it takes to bring therapeutically important medical products to the market by leveraging prior knowledge.
Under the auspices of this initiative, FDA, in conjunction with academia launched an initiative in August 2006 called the Analgesic Clinical Trials Project (ACTP) focused on identifying scientific gaps in the design, implementation and interpretation of clinical trials of acute and chronic analgesic drug products, and on implementing projects that will bridge these gaps. Under the ACTP, FDA and academia have initiated work to coordinate and support a series of research projects, all focused on analgesic clinical trial design and product development. Through the ACTP, FDA and academia are identifying scientific gaps in the aforementioned areas, prioritizing projects based on public health needs and implementing them through the leveraging of resources and technical expertise from multiple partners.
In spite of the enormous advances in drug development over the past two or three decades, (e.g., drugs that cure cancer, biologic drug products that halt the progression of rheumatoid arthritis), the development of novel analgesic drug products has seriously lagged behind. Indeed, to this day, the only analgesic drug products that are used widely and successfully are opioids, acetaminophen and the non-steroidal anti-inflammatory agents (NSAIDs), all of which have serious, potentially life-threatening toxicities even when used properly. While there has been exploration at the earliest stages of drug development, there has been wide'-spread reluctance on the part of the pharmaceutical industry to take novel products further into development. This is in no small part due to the often daunting task of demonstrating the efficacy of analgesics in clinical trials. Many experts in analgesic drug development believe that it is the design of the clinical trials that is - at fault in this situation, and that better trial designs will yield more successful results. This hypothesis is certainly supported by the frequent failures of clinical efficacy trials of opioid drug products, considering the well established effectiveness of these products from literally thousands of years of clinical experience.
IV. Objective:
FDA wishes to engage contractors to provide research and assistance in developing statistical methodologies to examine the use, in peri-operative pain trials, of combined pain scores and scores of rescue medication use for comparisons of differences in effect between study treatments.
V. Scope of Work:
Independently and not as an agent of the Government, the contractor shall furnish the necessary personnel, materials and services necessary for performance of the work as described below.
The contractor shall specify the methods it will employ in accomplishing the key tasks identified. All data and outcomes associated with this scope of work shall be provided to and go through the Project Officer (PO), to the FDA. A final report shall be prepared by the contractor that summarizes the deliverables of this contract.
The contractor shall identify clinical trials evaluating the analgesic effects of various treatments in patients also receiving intravenous opioid and other rescue medication during the peri-operative period.
The contractor shall, based on expert feedback and in collaboration with FDA staff, compile a list of possible statistical procedures for combined analysis of pain and analgesic rescue scores and determine which methods are best suited for analysis of the data.
The contractor shall then further evaluate the aforementioned data using the identified statistical methods, to determine which analysis methods will potentially provide evidence of treatment efficacy when it truly exists, and avoid false negative as well as false positive results.
The contractor shall lead the development of appropriate publication/s and/or report/s, in collaboration with FDA staff on summaries and other finding from this Statement of Work, the number and content of which shall be mutually agreed upon by the contractor and the FDA Project Officer.
VI. Relationship of Requirement to Other Contracts/Grants:
There are no known contracts related to this requirement.
VII. Reporting Requirements and Deliverable Items:
The activities and deliverables under this Statement of Work must be completed during a one year period from the date of execution of the contract. Any extension (including No Cost Extensions) of this timeline must be done in writing and must be authorized by the PO.
Deliverable Weeks After Start of Contract
1. Kick-off Meeting with FDA Within 2 weeks
2. Project Workplan with identification of the appropriate clinical studies and databases 6 weeks
6. FDA briefings at key milestones, per the Workplan 6 weeks to 10 months
7. Final meeting with FDA including draft report 10 months
8. Final report 12 months
Criteria for Acceptance of Deliverables:
The contractor shall implement and maintain a quality assurance system to ensure the product integrity of all deliverables that meets or exceeds the requirements established in this SOW. Final inspection and acceptance of all work performed, reports and other deliverables shall be performed at the place of delivery by the PO. [General quality measures, as set forth below, shall be applied to each work product received from the contractor under this statement of work.
Content-Work products shall be inclusive of all items mentioned in the objectives and scope along with content identified in [or by] the assessments.
Accuracy Work Products shall be accurate in presentation, technical content, and adherence to accepted elements of style.
Clarity Work Products shall be clear and concise. Any/All diagrams and graphics shall be easy to understand and be relevant to the supporting narrative.
Consistency to Requirements All work products must satisfy the requirements of this statement of work.
File Editing All text and diagrammatic files shall be editable by the Government.
Format - Work Products shall be submitted in hard copy (where applicable) and in media mutually agreed upon prior to submission.
Timeliness Work Products shall be submitted on or before the due date specified in this statement of work or submitted in accordance with a later scheduled date determined by the Government.
VIII. Duration of Project:
The activities and deliverables under this Statement of Work must be completed during a one year period from the date of execution of the contract. Any extension (including No Cost Extensions) of this timeline must be done in writing and must be authorized by the PO.
IX. Independent Government Cost Estimate: see attached
X. Funding of Project:
FY 2008 cost is estimated to be $50,270 based on the Independent Government Cost Estimate for this project.
XI. Evaluation Criteria
A. General - The offeror shall submit a technical proposal that covers the type of work described in Section V, Scope of Work. The offeror shall submit a business proposal that includes ceiling hourly rates (unloaded) for all labor categories.
Proposals received will first be evaluated from a technical standpoint without regard to proposed costs. Those proposals that are considered technically acceptable will be evaluated from a financial and management standpoint.
B. Technical Evaluation - This evaluation will be based upon the thoroughness of the proposal submitted. The offeror should show an understanding of the objectives and offer a logical program for their achievement. The following factors will be weighted as indicated in establishing a numerical rating for all technical proposals submitted.
Evaluation Criteria Weight
(Total of 100 points)
1) Personnel Experience Total 40 points
Factors to be considered include:
o Education, skills and experience of the proposed staff with respect to the tasks delineated in the Scope of Work
o Availability of proposed resources to commit to the contract
o Experience outlined under Special Terms and Conditions
2) Organizational Experience Total 20 points
Factors to be considered include:
o Offeror s expertise in analgesic clinical trials
o Past performance and participation in similar efforts
o Degree to which the Offeror s organization is able to support the efforts proposed
o Experience outlined under Special Terms and Conditions
3) Technical Approach Total 20 points
Factors to be considered include:
o Plan for how the Offeror will staff and execute the project
o Experience outlined under Special Terms and Conditions
4) Data Access and Resources Total 10 points
Factors to be considered include:
o Capability to collect primary data and ability to work with databases of varying formats and sizes
o Ability to work with both quantitative and qualitative data
o Experience outlined under Special Terms and Conditions
5) Project Management Total 10 points
Factors to be considered include:
o Demonstrated ability to manage projects of this kind
o Experience outlined under Special Terms and Conditions
XV. Special Terms and Conditions
1) Personnel Experience
a) Offeror shall demonstrate that it has medical personnel with extensive experience in (i) performing analgesic clinical trials (ii) examining such data, and (iii) devising innovative methods for clinical trials. These personnel should be considered experts in the field of pain medicine and research, as evidenced by adoption of their innovations as standard methods by the field, service on editorial boards of leading journals that publish pain research, consultancy for industry and/or the FDA, scientific awards, NIH grants, and publications of journal articles and/or text books, and
b) Offeror shall demonstrate that it has statistical personnel with a special interest in the type of data, clinical considerations and challenges of pain studies, and who can dedicate their time and provide sustained attention to this project over its duration. The statistical personnel should have a doctorate degree in biostatistics and have demonstrated ability to work with large and multiple datasets, and
c) Offeror shall demonstrate that it has medical personnel that are expert in regional anesthesia including but not limited to local and regional nerve blocks. The offeror shall demonstrate that it has experts in regional anesthetic techniques used in various patient subgroups, and
d) Offeror shall demonstrate that it has experience in analgesic clinical trials and experience in pain research. Offeror shall demonstrate that these resources and infrastructure will be dedicated to this project, and
e) Offeror shall demonstrate that it is nationally recognized as a pain research institution, as demonstrated by the number and scope of pain-related and anesthesia-related NIH grants, institutional grants for clinical research training, and authorship of relevant literature, and
f) Offeror shall demonstrate that it employs the personnel requisite to perform high caliber qualitative and quantitative analyses over the range of studies and evaluations presented in Section 5, Scope of Work.
2) Organizational Experience
Offeror shall demonstrate its expertise in analgesic clinical trials. Expertise shall be evidenced by such factors as previous conduct of pain trials, development of innovative analgesic trial designs, creation of novel outcome measures and statistical analyses of analgesic trial data, extensive publications, citations and awards for work in analgesic clinical trials. Offeror shall demonstrate its unique biostatistical interest and analytical abilities in analgesic pain trials. Offeror shall demonstrate the ability for liaison with contracting organizations, including operational staff.
3) Technical Approach
The offeror shall demonstrate expertise in data normalization, parametric and non-parametric tests, identification and selection of appropriate statistical methodologies for the required data analyses. It shall also demonstrate the ability to apply relevant elements of evaluation and statistical techniques.
4) Data Access and Resources
Offeror shall demonstrate primary data collection capability and the ability to work with databases of varying formats and sizes. .
5) Project Management
Offeror shall provide information on the administration of the project tasks. This should include management plans, methods for implementing, reviewing and effecting interim adjustments and corrections, and quality control and cost control procedures.
XVI. Identification and Disposition of Data
Offeror agrees not to disclose any such data to any persons except FDA employees having a need to know for the conduct of FDA business.
REQUEST FOR QUOTE (RFQ) Any firm that believes it is capable of providing the required service as stated herein may submit a proposal to document its ability to provide the required services, which will be considered if received by the fifteenth (15th) calendar day following the appearance of this announcement. A determination to compete this procurement based on a response to this notice is solely within the discretion of the Government. All responses or questions regarding this posting must be in writing and can be sent via email to joseph.pishioneri@fda.gov. No phone calls will be accepted. This sole source procurement will be awarded as a simplified acquisition for commercial items in accordance with FAR Subpart 13.5.
