Medicines and risk / benefit decisions proceedings of Centre for Medicines Research Workshop held at the Ciba Foundation, London, October 1, 1985

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. 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 WorkƯ 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 Front Matter....Pages i-xiv Introductory remarks....Pages 1-2 Front Matter....Pages 3-3 The risks in society....Pages 5-12 The risks from diseases....Pages 13-21 Perception of risk....Pages 23-41 Back Matter....Pages 43-46 Front Matter....Pages 47-47 Risk predicted from animal studies....Pages 49-56 The risk identified from clinical trials....Pages 57-65 The risk determined from PMS studies....Pages 67-71 Back Matter....Pages 73-81 Front Matter....Pages 83-83 Clinical benefits....Pages 85-90 Economic benefits....Pages 91-97 Psycho-social benefits....Pages 99-107 Back Matter....Pages 109-112 Front Matter....Pages 113-113 Risk-benefit decisions in human administration....Pages 115-122 Risk-benefit decisions in human administration....Pages 123-125 Risk-benefit decisions in product licence applications....Pages 127-134 Risk-benefit decisions in product licence applications....Pages 135-136 Risk-benefit decisions in licensing changes....Pages 137-141 Risk-benefit decisions in licensing changes....Pages 143-145 Risk-benefit decisions in patient care....Pages 147-151 Risk-benefit decisions in patient care....Pages 153-154 Risk-Benefit Decisions....Pages 155-156 Back Matter....Pages 157-161 Back Matter....Pages 163-165