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Comparing therapeutic benefit and risk.

Theoretically, the merit of a medical drug can be quantitatively determined by calculating benefit and risks as the drug-attributed gain or loss, respectively, of quality-adjusted life years. This calculation is based on comprehensive data concerning large numbers of patients. For most drugs, however, the data available are more or less incomplete. Therefore, large-scale intensive and continuous data collection needs to become routine in medical and pharmaceutical practice. In addition, important scientific, ethical, logistic and financial obstacles need to be overcome. Preliminary evidence suggests that the 'Principle of Threes' is a useful tool for categorizing the merit of drugs and for comparing drugs of a given therapeutic class. The safety of a drug is a dynamic rather than a constant feature. The merit of a drug is not an absolute quality, but is meaningful only in a given context. It is still uncertain whether merit assessment can present the dilemma that 'a drug causes benefit in many at the cost of serious injury in some' in a way the individual user can understand. Quantitative merit assessment will be welcome but should not be expected to replace individual therapeutic decision making. It remains to be seen whether merit assessment is to result in a gold standard for the acceptability or unacceptability of drugs.

Drug Therapy↗
PubMed1980

Medical execution.

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Capital Punishment↗
PubMed2002

Lost sleep....

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Drug Industry↗
PubMed2000

Necessary evil?

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Clinical Trials as Topic↗
PubMed2006

Ethics in clinical drug trial research in private practice.

INTRODUCTION: Private clinics and clinicians have been involved in clinical drug trials for approximately two decades. This paper reviews the ethical consideration inherent in this process. METHODS: Involvement of a single community based, private, Australian neurological clinic in the conduct of trials was audited. Changes in ethical considerations were analysed. RESULTS: The clinic previously audited its clinical trial involvement, starting with pharmaceutical company orchestrated trials. These were vetted by hospital based ethics committees (ECs) which then refused to review private research. A private EC accommodating NH & MRC standards was formed to assess private research. Indemnity concerns forced return to institutional ECs with government guaranteed indemnification. Trials evolved to investigator initiated, company sponsored studies thence a company asking the clinic to devise, sponsor and manage a trial. The latter relegated trial co-ordination to the clinic which would control publication thereby creating new ethical standards. DISCUSSION: Private practice trial involvement evolved from reluctant inclusion to a pivotal role in privately sponsored studies. Access to ECs is government endorsed and publication is independent for investigator-sponsored trials. There has been modification of standard operating procedures and enhanced ethical standards.

Australia↗