Medicines and Risk/Benefit Decisions

1. Front Matter

   Pages i-xiv

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2. Introductory Remarks

   1. Introductory remarks

      • S. R. Walker

      Pages 1-2

3. Risks in Perspective

   1. Front Matter

      Pages 3-3

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   2. The risks in society

      • T. R. Lee

      Pages 5-12

   3. The risks from diseases

      • A. Smith

      Pages 13-21

   4. Perception of risk

      • J. Urquhart

      Pages 23-41

4. Back Matter

   Pages 43-46

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5. Assessing the Risks from Medicines

   1. Front Matter

      Pages 47-47

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   2. Risk predicted from animal studies

      • G. Zbinden

      Pages 49-56

   3. The risk identified from clinical trials

      • C. T. Dollery

      Pages 57-65

   4. The risk determined from PMS studies

      • D. H. Lawson

      Pages 67-71

6. Back Matter

   Pages 73-81

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7. Measuring the Benefits of Medicines

   1. Front Matter

      Pages 83-83

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   2. Clinical benefits

      • J. D. Fitzgerald

      Pages 85-90

   3. Economic benefits

      • G. Teeling Smith

      Pages 91-97

   4. Psycho-social benefits

      • C. R. B. Joyce

      Pages 99-107

8. Back Matter

   Pages 109-112

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9. Risk-Benefit Decisions

   1. Front Matter

      Pages 113-113

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   2. Risk-benefit decisions in human administration

      • R. W. Brimblecombe

      Pages 115-122

   3. Risk-benefit decisions in human administration

      • C. F. George

      Pages 123-125

The third CMR Workshop prov. ided the opportunity for a group of experts from the Industry, academia and the regulatory authorities to meet and discuss ways and means by which risk benefit decisions are made during the various stages of drug development. It became apparent from the discussions that took place in October 1985, at the CIBA Foundation, that decisions are often made with limited data and inadequate methodology. The conclusions drawn from the day's deliberations were as follows: 1. Current methodology for assessing risk and particularly benefits must be improved; 2. Safety must be assessed in association with benefits as it is ultimately the benefit/ risk ratio which should decide the future of medicines; 3. Risks from medicines must always be viewed in relation to the risks from untreated diseases. It seemed to be the consensus of the group that such a meeting was both useful and informative and, hopefully, the publication of these proceedings will stimulate further discussion in this important area which may improve the decision-making process in drug development. The Editors wish to thank the participants for contributing to the Work­ shop, together with Dr. Cyndy Lumley for providing the initial transcript of the meeting and Mrs Sheila Wright for producing the final version and for carrying out all the additional work that is entailed in producing such a publication. Professor S. R. Walker A. W.

• care
• clinical trial
• diseases
• medicine
• perception
• research

• Carshalton, Surrey, UK

  Stuart R Walker

• University of Wales College of Medicine Royal Infirmary, Cardiff, UK

  A William Asscher

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