FERTILITY DRUGS AND OVARIAN CANCER NIH GUIDE, Volume 22, Number 31, August 27, 1993 RFP AVAILABLE: NICHD-CRE-93-12 P.T. 34 Keywords: Human Reproduction/Fertility Pharmaceuticals Cancer/Carcinogenesis National Institute of Child Health and Human Development The Contraceptive and Reproductive Evaluation Branch, National Institute of Child Health and Human Development (NICHD), seeks sources for a study of the long-term sequelae of exposure to fertility drugs. The primary objective is to determine whether and, if so, to what degree, exposure to ovulation-inducing drugs increases the risk of ovarian cancer. The secondary objective is to shed light on other potentially serious adverse effects of ovulation induction. The proposed cohort study would involve subjects from one or more well-defined historic cohorts with data already collected on reproductive, personal, familial, and any other relevant risk factors, including complete fertility drug history (dosage and duration of usage), as well as histological diagnoses of any malignancies occurring among the participants. Enough women must have been already enrolled to ensure sufficient statistical power to test hypotheses in subsets of the data, such as anovulatory versus other forms of infertility and women of different parity and gravidity. Due to the relative rarity of ovarian cancer, all interested parties must be able to document the existence of an historic cohort currently providing at least 30,000 woman-years of follow-up after exposure. This requirement is based on available incidence data to detect a three-fold difference in risk of ovarian cancer. Offerors should have expertise in the field of reproductive epidemiology, particularly with regard to ovulation induction and ovarian cancer. Offerors should also have experience in assembling and obtaining adequate follow-up of large cohorts and in collecting, managing, and analyzing large epidemiologic data bases. The Government estimates the effort to be approximately 4.5 technical staff-years. It is anticipated that one cost-reimbursement incrementally funded type contract will be awarded for a period of 54 months. INQUIRIES This announcement is not a request for proposals (RFP). RFP No. NICHD-CRE-93-12 is now available. Copies of the RFP may be obtained by sending a written request, with a self-addressed label, or a FAX request to: Charles W. Grewe, Contracting Officer Office of Grants and Contracts National Institute of Child Health and Human Development 6100 Building, Room 7A07 Bethesda, MD 20892 FAX: (301) 402-3676 .
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