Partnership in Applied Comparative Effectiveness Science (PACES).

****Modification 2 to Presolicitation Notice ARRA-OS-PACES_Presolicitation**** The purpose of this modification is to update the solicitation release date to the following: The anticipated release date of the solicitation has been updated to read on May 14, 2010. All other terms and conditions remain unchanged. ****Modification 1 to Presolicitation Notice ARRA-OS-PACES_Presolicitation**** The purpose of this modification is to answer questions received in response to the presolicitation and update the solicitation release date: I. Questions and Answers: Question 1: Is this a small business set -aside? Answer 1: The presolicitation clearly states "FDA intends to solicit this requirement as "Full and Open Competition." Question 2: Please clarify, the Presolicitation states "The NAICS Code is 541712 with a small business size standard of 500 employees" and also states "FDA intends to solicit this requirement as a Full and Open competitive requirement." Answer 2: As stated in Part D this is a Full and Open Competitive Requirement: SBA has established numerical definitions, or "size standards," for all for-profit industries. Size standards represent the largest size that a business (including its subsidiaries and affiliates) may be to remain classified as a small business concern. Additional information on size standards can be found at http://www.sba.gov/contractingopportunities/officials/size/index.html. II. Updates The anticipated release date of the solicitation has been updated to read on or around May 10, 2010. All other terms and conditions remain unchanged. _________________________________________________________________________ The Food and Drug Administration (FDA) intends to solicit proposals under solicitation number 10-223-SOL-00065 (subject to change) for an initiative called "Partnership in Applied Comparative Effectiveness Science" (PACES). PACES is an initiative that seeks to advance the science for such CER studies through leveraging available data, in particular the joint ARRA FDA-CER efforts, to form an enhanced standardized database, Janus. The NAICS Code is 541712 with a small business size standard of 500 employees. This requirement will be funded by the Recovery Act. A. Project Background Initiatives to compare the effectiveness of different medical interventions and approaches to their delivery have attracted tremendous interest. While comparative effectiveness research (CER) has typically been associated with enhancing the efficiency in the use of health care resources, there is a broader vision of the potential goals and benefits of such research. CER could extend beyond the application of specific intervention methods to controlled clinical trials or within specific health care settings. For example CER could be used to better understand what interventions work best for individuals and subgroups within populations. As such, CER can be instrumental in supporting and driving the development of personalized medicine, and improving not only the efficiency of care, but also outcomes for all individuals. The science can be used to increase patient benefit, by identifying individuals who are most likely to benefit from an intervention, and to reduce risks, by identifying and protecting individuals who may be harmed. The hope of personalized medicine is that new and existing therapies and devices will be used in combination with improved diagnostic assessments to develop a tailored strategy for treating each patient. A significant step in achieving this goal is to define subtypes or subpopulations of patients with disease, such that different therapies, often with different targets and mechanisms of action, can be compared with respect to how they perform in each of these subtypes. Within the FDA, the intent is to help provide a scientific framework that can capitalize on increased CER efforts to better realize these goals of personalized medicine. The FDA houses the largest known repository of clinical study data--including data on drug biologics and devices safety, effectiveness and performance. These data are an invaluable resource for CER. Both pre- and post-approval data collected and housed at the FDA can be combined with other datasets on long term health outcomes that reside in other agencies or the private sector. As personalized medicine develops, FDA expects an increase in the need for comparisons across products (and associated delivery mechanisms) to define how these products should be used in combination for individualized health care before and after FDA approval. Development and use of sound, consistent science-based approaches to the design, conduct and analysis of such data and the assessment for labeling and regulatory purposes, will be critical. B. Objective The Partnership in Applied Comparative Effectiveness Science (PACES) is an initiative that seeks to advance the science for such CER studies through leveraging available data, in particular the joint ARRA FDA-CER efforts, to form an enhanced standardized database, Janus. The PACES initiative will be conducted with a contractor who has biological, and clinically relevant computational expertise. The contractor will work with FDA Center scientific and statistical experts to define questions, datasets and approaches for performing complex analyses for comparative and multi-study analyses on FDA and other large clinical datasets. As part of this effort, the contractor will conduct analyses on defined datasets including datasets previously developed as part the joint Janus initiative, where FDA's Center's specific questions will drive the data transformed, standardized and loaded into the Janus data warehouse. Additionally, the contractor will be expected to participate in FDA-hosted scientific workshops that address issues such as methods for cross-study and other comparative analyses, best practices in CER, and candidate studies and their design and analysis methods. These strategies will also encompass clinical trial designs that can help advance personalized medicine and health outcomes both within and outside of the FDA. C. Scope: The Contractor shall conduct CER. This work effort shall include four principle components as follows: - Component 1- The Contractor shall plan and organize the CER project with FDA stakeholders, including participation in annual FDA-hosted planning workshops (three workshops, two days each) to define candidate CER questions and priorities, analyses strategies and datasets to be utilized. - Component 2- The Contractor shall provide training on methodologies developed to FDA staff during two of the FDA-hosted planning workshops. - Component 3 - The Contractor shall identify or develop appropriate analytic methodologies for CER and apply them to FDA and/or other data; develop new scientific computing strategies and hone existing computational strategies to perform these CER analyses. The Contractor shall prepare reports and manuscripts of the results suitable for publication in scientific journals. - Component 4- The Contractor shall develop innovative clinical trial design strategies for prospective CER clinical trials and analyses of healthcare data including providing formal recommendations for best practices for submission of studies to the FDA when they involve product comparisons. These strategies and recommendations shall be documented in reports and manuscripts suitable for publication in scientific journals. D. Additional Information It is anticipated that one (1) or more contracts will be awarded with a three (3) year base period from August 01, 2010 to July 31, 2013 with two (2) one (1) year options. FDA intends to solicit this requirement as a Full and Open competitive requirement. This announcement is not a request for proposal (RFP). The solicitation will be an upload to this pre-solicitation notice. NO PHONE CALLS WILL BE ENTERTAINED. Please send questions or comments in writing to Dominique.Malone@fda.hhs.gov. It is up to interested parties to check this site for the release of the solicitation as it will be available on the Federal Business Opportunities (FedBizOpps) website. The anticipated release date of the solicitation will on or around May 10, 2010. Please watch this synopsis for updated information (if any) to the release date. The anticipated award date for this effort is August 2010.