A cost-related approach for evaluating drug development programs. 2004

Eric C Yan, and Ling Chen
Pfizer Inc. La Jolla Laboratories, 11085 Torreyana Road, San Diego, CA 92121, USA.

Most pharmaceutical statisticians make a contribution to drug development at the study level by designing and analysing clinical studies. There is less involvement at the drug project level, especially when it comes to making a strategic decision for a drug development program. Motivated by the assessment of drug safety, this paper presents a new decision rule on whether or not to continue developing a new drug based on a cost function. The cost function takes into account both type I and type II errors in a decision making problem. It also incorporates both the cost and benefit from a drug development program. This cost-benefit approach enables company senior management to evaluate a drug program objectively and make decisions in a quantitative and rational manner. The probabilities of making correct decisions are illustrated by using a real data example.

UI MeSH Term Description Entries
D002986 Clinical Trials as Topic Works about pre-planned studies of the safety, efficacy, or optimum dosage schedule (if appropriate) of one or more diagnostic, therapeutic, or prophylactic drugs, devices, or techniques selected according to predetermined criteria of eligibility and observed for predefined evidence of favorable and unfavorable effects. This concept includes clinical trials conducted both in the U.S. and in other countries. Clinical Trial as Topic
D003362 Cost-Benefit Analysis A method of comparing the cost of a program with its expected benefits in dollars (or other currency). The benefit-to-cost ratio is a measure of total return expected per unit of money spent. This analysis generally excludes consideration of factors that are not measured ultimately in economic terms. In contrast a cost effectiveness in general compares cost with qualitative outcomes. Cost and Benefit,Cost-Benefit Data,Benefits and Costs,Cost Benefit,Cost Benefit Analysis,Cost-Utility Analysis,Costs and Benefits,Economic Evaluation,Marginal Analysis,Analyses, Cost Benefit,Analysis, Cost Benefit,Analysis, Cost-Benefit,Analysis, Cost-Utility,Analysis, Marginal,Benefit and Cost,Cost Benefit Analyses,Cost Benefit Data,Cost Utility Analysis,Cost-Benefit Analyses,Cost-Utility Analyses,Data, Cost-Benefit,Economic Evaluations,Evaluation, Economic,Marginal Analyses
D004358 Drug Therapy The use of DRUGS to treat a DISEASE or its symptoms. One example is the use of ANTINEOPLASTIC AGENTS to treat CANCER. Chemotherapy,Pharmacotherapy,Therapy, Drug,Chemotherapies,Drug Therapies,Pharmacotherapies,Therapies, Drug
D006801 Humans Members of the species Homo sapiens. Homo sapiens,Man (Taxonomy),Human,Man, Modern,Modern Man
D014481 United States A country in NORTH AMERICA between CANADA and MEXICO.
D015397 Program Evaluation Studies designed to assess the efficacy of programs. They may include the evaluation of cost-effectiveness, the extent to which objectives are met, or impact. Evaluation, Program,Family Planning Program Evaluation,Program Appropriateness,Program Effectiveness,Program Sustainability,Appropriateness, Program,Effectiveness, Program,Evaluations, Program,Program Evaluations,Program Sustainabilities,Sustainabilities, Program,Sustainability, Program
D064420 Drug-Related Side Effects and Adverse Reactions Disorders that result from the intended use of PHARMACEUTICAL PREPARATIONS. Included in this heading are a broad variety of chemically-induced adverse conditions due to toxicity, DRUG INTERACTIONS, and metabolic effects of pharmaceuticals. Drug-Related Side Effects and Adverse Reaction,Adverse Drug Event,Adverse Drug Reaction,Drug Side Effects,Drug Toxicity,Side Effects of Drugs,Toxicity, Drug,Adverse Drug Events,Adverse Drug Reactions,Drug Event, Adverse,Drug Events, Adverse,Drug Reaction, Adverse,Drug Reactions, Adverse,Drug Related Side Effects and Adverse Reaction,Drug Related Side Effects and Adverse Reactions,Drug Side Effect,Drug Toxicities,Effects, Drug Side,Reactions, Adverse Drug,Side Effect, Drug,Side Effects, Drug,Toxicities, Drug

Related Publications

Eric C Yan, and Ling Chen
January 1978, Nursing administration quarterly,
Eric C Yan, and Ling Chen
March 1976, Inquiry : a journal of medical care organization, provision and financing,
Eric C Yan, and Ling Chen
January 1995, Journal of drug education,
Eric C Yan, and Ling Chen
January 1987, Journal of drug education,
Eric C Yan, and Ling Chen
June 1979, Evaluation & the health professions,
Eric C Yan, and Ling Chen
August 1986, AAOHN journal : official journal of the American Association of Occupational Health Nurses,
Eric C Yan, and Ling Chen
September 1986, Evaluation & the health professions,
Eric C Yan, and Ling Chen
July 1980, Journal of studies on alcohol,
Eric C Yan, and Ling Chen
May 2022, Journal of pharmaceutical sciences,
Eric C Yan, and Ling Chen
April 2018, Evaluation and program planning,
Copied contents to your clipboard!