National Institutes of Health, Research Contracts Branch, DCG/OA/OD, 6100 Executive Blvd., MSC 7540, Room 6E01, Bethesda, Maryland 20892- 7540

R -- OPHTHALMIC CLINICAL TRIALS AND STATISTICAL STUDY MONITORING AND COORDINATION POC Karen M. Gamble, Contracting Officer, (301) 496-4487. The National Institutes of Health is seeking qualified small business firms to provide clinical trial support for the National Eye Institute. Contractor shall provide services consisting of clinical trial design, study design, sample size calculations, and identification of appropriate study endpoints and statistical analyses. Reading center services for the evaluation of photographs and fluorescein angiograms taken during the course of the studies will also be required. Other services that will be required include: development and preparation of protocols, preparation and design of computer capabilities to collect data elements prescribed in the study protocol and analyze study data, provision of data analyses including standard statistical techniques utilized in the analysis of clinical trials (e.g., life table methods and logistic and multivariate analysis), preparation of reports by protocol including patient accrual, eligibility, and evaluability information, as well as comprehensive reporting of treatment-related toxicity, notification of protocol violations or reported toxicities of investigational drugs, clinic coordinators to assist in the conduct of trials, coordinators shall assure patients' compliance with study requirements, coordinate and monitor the various examination, diagnostic, and photographic procedures, and decrease missed visits and losses to follow-up, assistance in the design of a computerized system to organize clinical data collected during ocular examinations, the capability of reproducibly analyzing external and internal ophthalmic photographs and fluorescein angiograms of study patients, assistance to investigators in the preparation of manuscripts or abstracts related to specific clinical trials, including preparation and revision of drafts, development of scientific and administrative information relevant to the clinical trials, assistance in the development and preparation of publicity materials for clinical trials to improve patient recruitment, based on protocol specification and distribution of materials to selected target audiences. Natural history and outcomes research studies may include as many as 10 clinics. The contractor shall continue support for these studies by providing assistance in the retrieval, formatting and analysis of information for the interpretation and evaluation of data. This support shall consist, in part, of: developing databases from available information (e.g., Medline), assistance in the appropriate design and review of Quality of Life studies, including the design and testing of outcomes research instruments, assistance in the concept review of proposed studies, design of data collection instruments and development of data collection procedures for use in analysis of overall results of epidemiologic studies. Pertinent data might relate to any or all aspects of a subset (e.g., disease and stage specific) of studies, including study design, methodology, results, and quality of conduct. It will be necessary for the clinic coordinators and possibly a data technician to work on the Government's site. Contractor must be knowledgeable regarding the problems, issues, and scientific efforts associated with eye disease and visual disorders and suggested solutions, the design of clinical trials and epidemiologic and outcomes research, and criteria and protocols for evaluating the performance of new therapies in terms of quality of life. Integrity of research must be protected including assuring patient safety through a data and safety monitoring committee. Personnel must be well qualified in ophthalmic epidemiology and clinical trials. THIS IS NOT A REQUEST FOR PROPOSAL (RFP). NO RFP IS AVAILABLE AT THIS TIME. Small business concerns that believe that they possess the capabilities to perform this work must submit an original and two copies of a capability statement to the address listed above not later than 15 days after the date of this publication. The Standard Industrial classification Code (SIC) is 7379. (0067)

Loren Data Corp. http://www.ld.com (SYN# 0088 19950309\R-0020.SOL)