New drugs for perinatal practice: The role of industry-sponsored clinical trials

Abstract

M edical discoveries, no matter how brilliant, cannot improve clinical care unless they are actually used. The marketplace is the instrument by which medical products are provided to patients who need them. In North America, the development of new medical products to the point of marketing is both highly regulated and highly competitive. Both the development and initial marketing of any medical innovation are difficult challenges in themselves, but the difficulties involved are probably a logfold greater for new pharmaceutical products than for new items of medical equipment, because far tighter regulatory hurdles are imposed by the Food and Drug Administration (FDA) and Health Protection Branch (HPB), respectively, in the USA and Canada for new drugs. Randomized clinical trials are the safest, most ethical, and most efficient mechanism for introducing innovations to all areas of clinical medicine, including perinatal practice. Successful commercialization of such innovations requires ei ther the direct or indirect sponsorship of well established commercial enterprises. These enterprises must have the requisite capital, technical resources, and knowledge to produce the innovation reliably, to evaluate the innovation in the clinic in a rigorous manner, to secure the necessary regulatory approvals, and to market the innovation successfully. Whether a potential innovation for perinatal practice ever reaches industry-sponsored clinical trials, much less the perinatal market, is determined by the interplay o f a wide variety of forces. This article will review the role of industrysponsored clinical trials in improving perinatal