title: A perspective on risks that impede development of drugs to modify the course of Alzheimer's disease: can they be reduced?
abstract: Discovery, development, and testing of new drugs with novel mechanisms and new indications are extremely risky. The number of new drugs introduced into clinical practice with new mechanisms and novel indications has not increased during recent years in spite of advances in biologic science. The sources of uncertainty leading to failure in drug development are discussed in three categories: biologic or target risk, clinical development uncertainty, and market uncertainty. Efforts to develop drugs that modify the course of Alzheimer's disease and/or delay the initial clinical manifestations of disease are subject to all three types of risk. Opportunities for government, academic researchers, advocacy groups, and the pharmaceutical industry to mitigate some of these risks and possibly speed the introduction of new therapies are mentioned.
authors.affiliation: Neuroscience, Medical, Lilly Research Laboratories, Eli Lilly and Co, Indianapolis, IN, USA. mohsri@lilly.com
authors.forename: Richard C
authors.initials: RC
authors.lastname: Mohs
mesh_terms: D000544:Alzheimer Disease / Q000188:drug therapy*; D001921:Brain / Q000187:drug effects; D002986:Clinical Trials as Topic / Q000331:legislation & jurisprudence / Q000379:methods / Q000706:statistics & numerical data; D017277:Drug Approval / Q000331:legislation & jurisprudence / Q000706:statistics & numerical data; D006801:Humans; D012306:Risk