Cancer drug development: The missing links

Exp Biol Med (Maywood). 2019 May;244(8):663-689. doi: 10.1177/1535370219839163. Epub 2019 Apr 8.

Abstract

The success rate for cancer drugs which enter into phase 1 clinical trials is utterly less. Why the vast majority of drugs fail is not understood but suggests that pre-clinical studies are not adequate for human diseases. In 1975, as per the Tufts Center for the Study of Drug Development, pharmaceutical industries expended 100 million dollars for research and development of the average FDA approved drug. By 2005, this figure had more than quadrupled, to $1.3 billion. In order to recover their high and risky investment cost, pharmaceutical companies charge more for their products. However, there exists no correlation between drug development cost and actual sale of the drug. This high drug development cost could be due to the reason that all patients might not respond to the drug. Hence, a given drug has to be tested in large number of patients to show drug benefits and obtain significant results.

Keywords: Cancer; clinical; cost; drugs; patient survival; pre-clinical.

Publication types

  • Research Support, Non-U.S. Gov't
  • Review

MeSH terms

  • Animals
  • Antineoplastic Agents* / adverse effects
  • Antineoplastic Agents* / economics
  • Antineoplastic Agents* / pharmacology
  • Antineoplastic Agents* / therapeutic use
  • Biomarkers
  • Biomarkers, Tumor / blood
  • Cell Line, Tumor
  • Clinical Trials as Topic
  • Developing Countries
  • Drug Approval
  • Drug Costs
  • Drug Design
  • Drug Discovery
  • Drug Screening Assays, Antitumor
  • Genome, Human
  • Humans
  • Mutation
  • Neoplasms / drug therapy*
  • Neoplasms / economics
  • Neoplasms / epidemiology
  • Neoplasms / genetics
  • Precision Medicine / trends
  • Primary Prevention
  • Proportional Hazards Models
  • Relaxation Therapy
  • Species Specificity
  • Survival Analysis
  • United States
  • United States Food and Drug Administration

Substances

  • Antineoplastic Agents
  • Biomarkers
  • Biomarkers, Tumor