Education And Debate

Call for a new approach to the process of clinical trials and drug registration

BMJ 2001; 322 doi: (Published 14 April 2001) Cite this as: BMJ 2001;322:920
  1. Thomas C Jones, adjunct professor of medicine (
  1. Cornell University Medical College, New York, NY 10021, USA
  1. Correspondence to: Thomas C Jones, Clinical Research Consultants, Basle 4058, Basle, Switzerland
  • Accepted 27 November 2000

The process of phases I-IV of clinical trials is the cornerstone of the drug registration and regulation process.1 Yet expanding drug expenses, the slow process of development in critical areas of need, poor worldwide distribution of new therapeutics, and an emerging multibillion dollar industry receiving finances for clinical trials as a part of healthcare delivery, indicate that the process needs revision. Recent changes in testing by clinical trials, different methods of supervision of drug development by pharmaceutical companies, and new methods for the monitoring of drug safety suggest a direction for this revision. A fresh approach is proposed (see boxes, p 921). This article reviews the basis for considering this new approach.

Summary points

The process of phases I-IV of clinical trials for drug registration is expensive, raises ethical issues of informed consent in phases III and IV, and has been expanded to try to answer too many questions

Careful assessment of recent, well constructed safety data from phase II studies compared with data from the end of phase III is expected to show little new safety information gained from phase III

A fresh approach to drug registration is needed

Suggested steps in new approach to drug assessment

  1. Summarise innovative aspects of the drug (based on chemistry of the drug, animal toxicology, mechanisms of action, and initial clinical trials) to identify special approaches to drug development that should be considered

  2. Summarise characteristics of the disease or diseases for which the drug is to be used, healthcare needs, and market pressures that indicate special risks or benefits regarding the drug's development

  3. Review data about the drug collected from countries outside of the region in which registration is occurring, and summarise data about drugs marketed by competitors

  4. Review patent issues, estimate the potential sales, and record the proposed drug price

  5. Enter into special negotiations regarding the approach for drug development based …

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