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Directive to the director of NIH from the membership of the society for clinical trials
Directive to the Director of NIH from the Membership of the Society for Clinical Trials 1
We, the undersigned, ascribe to the value of demographic heterogeneity in clinical trials. We do so in the belief that the value of such trials as a research tool for improving the collective health and well being of the world's population is enhanced by their being as broadly inclusive as possible and practical. We also ascribe to the principle that exclusions from clinical trials, on the basis of age, gender, or ethnic origin, should not be imposed, except where required by medical-legal restraint, or where justified on scientific or practical ground. The continued acquisition of knowledge about the effects of medical treatment depends upon the ability of society to mount clinical trials that address pressing questions about therapy. In order for such trials to provide reliable answers to the questions posed, sound scientific principles must dictate their design. Questions asked for political, not scientific, reasons so complicate study design and analysis that they may render a potentially valuable trial infeasible. In particular, we view with apprehension the implication under Section 131 of the NIH reauthorization bill that clinical trials shall generally be designed and analyzed to learn the degree to which demographic subgroups of the population differ is their responses to therapy. We believe few such questions are based on plausible scientific hypotheses. Therefore, we call upon the Director of the NIH to promulgate under Subsection of Section 131, a set of guidelines for clinical trials that encourage the inclusion of people into clinical trials without regard to sex, race, age, or ethnicity. The guidelines shall emphasize that the salient medical questions posed by the investigators shall determine the sample size of such trials, the demographic composition of the study cohorts, and the analyses to be performed. When the important questions pertain to the effect of treatment within a demographic subgroup or to the differences in treatment effect by such subgroup, the study shall be designed to address the stated hypothesis. The guidelines should make clear, however, that clinical trials shall not ordinarily be required to include either explicit or implicit demographic quotas.
1Drafted at the Annual Meeting of the Societyfor Clinical Trials 24-26, May 1993 Controlled ClinicalTrials 14:559(1993) © ElsevierSciencePublishingCo., Inc. 1993 655Avenueof the Americas,New York,New York10010
559 0197-2456/93/$6.00
We, the undersigned, ascribe to the value of demographic heterogeneity in clinical trials. We do so in the belief that the value of such trials as a research tool for improving the collective health and well being of the world's population is enhanced by their being as broadly inclusive as possible and practical. We also ascribe to the principle that exclusions from clinical trials, on the basis of age, gender, or ethnic origin, should not be imposed, except where required by medical-legal restraint, or where justified on scientific or practical ground. The continued acquisition of knowledge about the effects of medical treatment depends upon the ability of society to mount clinical trials that address pressing questions about therapy. In order for such trials to provide reliable answers to the questions posed, sound scientific principles must dictate their design. Questions asked for political, not scientific, reasons so complicate study design and analysis that they may render a potentially valuable trial infeasible. In particular, we view with apprehension the implication under Section 131 of the NIH reauthorization bill that clinical trials shall generally be designed and analyzed to learn the degree to which demographic subgroups of the population differ is their responses to therapy. We believe few such questions are based on plausible scientific hypotheses. Therefore, we call upon the Director of the NIH to promulgate under Subsection of Section 131, a set of guidelines for clinical trials that encourage the inclusion of people into clinical trials without regard to sex, race, age, or ethnicity. The guidelines shall emphasize that the salient medical questions posed by the investigators shall determine the sample size of such trials, the demographic composition of the study cohorts, and the analyses to be performed. When the important questions pertain to the effect of treatment within a demographic subgroup or to the differences in treatment effect by such subgroup, the study shall be designed to address the stated hypothesis. The guidelines should make clear, however, that clinical trials shall not ordinarily be required to include either explicit or implicit demographic quotas.
1Drafted at the Annual Meeting of the Societyfor Clinical Trials 24-26, May 1993 Controlled ClinicalTrials 14:559(1993) © ElsevierSciencePublishingCo., Inc. 1993 655Avenueof the Americas,New York,New York10010
559 0197-2456/93/$6.00