The Research Foundation of State University of New York

B-274269 Dec 02, 1996 Jump To VIEW DECISION RELATED PAGES GAO CONTACTS Highlights The contractor is to develop the research infrastructure for NIAID to address two essential issues . Advises that the major focus of the studies will be on the therapeutic effects of antimicrobial agents. The protocol is the offeror's technical approach to conducting the clinical study of the disease and includes such things as the drugs that the offeror proposed to utilize in studying treatment of the disease. The RFP advised offerors that "it is anticipated that a phase III study would require 150-300 patients. The technical criteria were "Scientific and Technical Approach" worth 50 percent. Both proposals were included in the competitive range. The offerors' proposed protocols were significantly different from each other. View Decision Matter of: The Research Foundation of State University of New York File: B-274269 Date: December 2, 1996 Agency reasonably accepted in its cost evaluation the proposed costs of proposals offering significantly different technical approaches to performing clinical studies where the solicitation contemplated proposals based upon the offerors' creativity in developing and designing their own protocols for the study and the agency reviewed the cost elements of each proposal and found each proposal's cost reasonable and realistic for the particular study proposed. Attorneys DECISION The Research Foundation of State University of New York (SUNY) protests the award of a contract to New England Medical Center (NEMC), by the Department of Health and Human Services, National Institute of Allergy and Infectious Diseases (NIAID), under request for proposals (RFP) No. NIH-NIAID-DMID-96-09, for clinical studies of chronic lyme disease. We deny the protest. [1] The RFP, issued June 15, 1995, contemplated a cost reimbursement, level-of-effort, contract for a 5-year term. The contractor is to develop the research infrastructure for NIAID to address two essential issues -- the evaluation of therapeutic approaches to treat patients with chronic lyme disease and the pathological basis/bases of the condition. [2] The statement of work requires the contractor to conduct clinical studies in patients with documented and well-defined chronic lyme disease, and advises that the major focus of the studies will be on the therapeutic effects of antimicrobial agents; that assessments of the pharmacological properties of drugs used singly or in combination with other therapeutic medications shall be part of the studies when necessary and appropriate; and that pilot studies of treatments for other manifestations or infections associated with lyme disease may also be proposed. The RFP required that each offeror, as part of its proposal, would develop and design protocol(s) for conducting clinical studies of lyme disease. The protocol is the offeror's technical approach to conducting the clinical study of the disease and includes such things as the drugs that the offeror proposed to utilize in studying treatment of the disease, the duration of the treatment, and the number of patients to be included in the study. The RFP required offerors to submit a detailed protocol for a controlled phase III study and also advised that they could submit up to two pilot studies as well if appropriate. The RFP advised offerors that "it is anticipated that a phase III study would require 150-300 patients, a phase II study would require 30-60 patients." The RFP contemplated that the offerors would rely upon their own creativity and expertise in developing and designing the offered protocol, and that the selected firm's protocol(s) likely would be modified after award based upon the recommendations of the project officer; to this effect, the RFP advised offerors that the award of the contract did not commit the government to approve any of the studies presented in the offeror's proposal -- that the project officer would determine the actual studies to be undertaken. The RFP advised that the technical evaluation would receive paramount consideration over cost, but that in the event of technically equal proposals, cost would become more important. The technical criteria were "Scientific and Technical Approach" worth 50 percent, "Personnel" worth 25 percent, and "Facilities/Resources" worth 25 percent. NIAID received proposals from SUNY and NEMC by the October 15 initial closing date. Both proposals were included in the competitive range; NEMC's proposal received a score of 58 points and SUNY's proposal received a score of 55 points. Following technical and cost discussions, the offerors submitted best and final offers (BAFO) by May 1, 1996. The offerors' proposed protocols were significantly different from each other.