The NIH Trials of Growth Hormone for Short Stature

Tauer, Carol A.

doi:10.2307/3563670

Cited by 14 publications

(13 citation statements)

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“…However, this could be said of any alternative research method and, while randomisation is not a perfect solution, it is perhaps the least bad scientific option for evaluations (Uberla, 1981). Churchill, 1995;Raju, 1992;Rudicel and Esdaile, 1985;Ruse, 1988;Rutstein, 1970;Schafer, 1982Schafer, , 1985Schwartz et al, 1980;Shuster et al, 1985;Simon, 1977Simon, , 1994Spiegelhalter et al, 1994;Spodick, 1973Spodick, , 1982Steinberg, 1991;Stirrat et al, 1992;Takaro et al, 1976;Tauer, 1994;Toynbee, 1996;Trochim and Cappelleri, 1992;Van der Linden, 1980;Vere, 1981;Visscher, 1970;Wallenstein et al, 1980;Weinstein, 1974;Zelen, 1969).…”

Section: Societal Benefitsmentioning

confidence: 99%

Ethical issues in the design and conduct of randomised controlled trials.

Edwards¹,

Lilford²,

Braunholtz³

et al. 1998

Health Technology Assessment

146

122

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Health Technology Assessment is indexed in Index Medicus/MEDLINE and Excerpta Medica/ EMBASE. Copies of the Executive Summaries are available from the NCCHTA web site (see overleaf). NHS R&D HTA Programme T he overall aim of the NHS R&D Health Technology Assessment (HTA) programme is to ensure that high-quality research information on the costs, effectiveness and broader impact of health technologies is produced in the most efficient way for those who use, manage and work in the NHS. Research is undertaken in those areas where the evidence will lead to the greatest benefits to patients, either through improved patient outcomes or the most efficient use of NHS resources. The Standing Group on Health Technology advises on national priorities for health technology assessment. Six advisory panels assist the Standing Group in identifying and prioritising projects. These priorities are then considered by the HTA Commissioning Board supported by the National Coordinating Centre for HTA (NCCHTA). This report is one of a series covering acute care, diagnostics and imaging, methodology, pharmaceuticals, population screening, and primary and community care. It was identified as a priority by the Methodology Panel and funded as project number 93/41/02. The views expressed in this publication are those of the authors and not necessarily those of the Standing Group, the Commissioning Board, the Panel members or the Department of Health. The editors wish to emphasise that funding and publication of this research by the NHS should not be taken as implicit support for the recommendations for policy contained herein. In particular, policy options in the area of screening will, in England, be considered by the National Screening Committee. This Committee, chaired by the Chief Medical Officer, will take into account the views expressed here, further available evidence and other relevant considerations. Reviews in Health Technology Assessment are termed 'systematic' when the account of the search, appraisal and synthesis methods (to minimise biases and random errors) would, in theory, permit the replication of the review by others.

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Section: Societal Benefitsmentioning

confidence: 99%

Ethical issues in the design and conduct of randomised controlled trials.

Edwards¹,

Lilford²,

Braunholtz³

et al. 1998

Health Technology Assessment

146

122

View full text Add to dashboard Cite

show abstract

“…A review committee appointed to scrutinize the ethics of the study concluded that the pain, inconvenience, and risks of the large number of injections constituted a risk "significantly greater than minimal," but that this risk was acceptable under the DHHS regulations. At least one member of the review committee disagreed with this conclusion, and I have argued that the committee's rationale incorrectly applies the regulations (Tauer, 1994).…”

Section: Phase 3 Studiesmentioning

confidence: 97%

“…For example, while the AAP "Guidelines for the Ethical Conduct of Studies... in Pédiatrie Populations" quote the DHHS regulations almost verbatim, little attention is given to controversial aspects in the interpretation of these regulations (AAP Committee on Drugs, 1995). The meanings of concepts such as "minimal risk" and "a minor increase over minimal risk," concepts that have occasioned much disagreement among commentators and IRBs (Kopelman, 1989;Prentice et al, 1989;Freedman et al, 1993;Tauer, 1994), are glossed over. In fact, the AAP guidelines appear to welcome a certain ambiguity:…”

Section: Ambiguities In Existing Guidelinesmentioning

confidence: 98%

Testing drugs in pediatric populations: The FDA mandate

Tauer

1999

Accountability in Research

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On November 27, 1998 the Food and Drug Administration (FDA) issued a new rule requiring that drugs and biological products be tested in pediatric populations. Since voluntary testing in pediatric populations had not resulted in a significant increase in pediatric labeling of drugs, stronger measures were needed to ensure that infants and children would receive the benefits of properly tested drugs and biologies. The mandate for pediatric testing raises a core ethical question: How should the need for validated treatments that benefit children as a group be weighed against the obligation to protect individual child subjects of research? The preamble to the new rule claims that adherence to Department of Health and Human Services (DHHS) and American Academy of Pediatrics (AAP) guidelines will provide adequate protection to individual subjects. Yet the special protections provided to children in these guidelines are not required by the new FDA rule, and have never been obligatory for research that is regulated by the FDA. While the new rule does not necessitate or encourage violation of these standards, the rule does not pay adequate attention to them nor clarify what role they should play in IRB review of protocols under FDA regulation.

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“…One excellent resource addressing regulatory and ethical issues is the NIH Clinical Center text edited by Emanuel et al [18•]. This is an examination of healthy children of short stature in clinical trials to mitigate social and psychological harm but not a disease, which led to the conclusion that the study utilizing growth hormone did not comply with the regulations [19]. A second piece examines the minimal risk threshold frequently criticized as vague and lacking in utility [20••].…”

Section: General Considerationsmentioning

confidence: 99%

Ethical considerations in research involving children

O'Lonergan

Milgrom

2005

Curr Allergy Asthma Rep

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Ethical concerns and medical advances unique to children and adolescents make pediatric research an evolving endeavor. The child's changing physiology from infancy to maturity requires understanding of the benefits and risks of medical therapies currently available, but often not tested in children, as well as the risks and benefits of inclusion of children in clinical research. Recent mandates from the US Food and Drug Administration (FDA) require that drugs be tested for safety and efficacy in children. Growing concern for the prevalence of chronic disorders and increasing understanding of distinct phenotypes of these disorders points to a likely need for unique interventions matched to specific phenotypes. All contribute to the increasing complexity of ethical considerations in pediatric research.

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The NIH Trials of Growth Hormone for Short Stature

Cited by 14 publications

References 0 publications

Ethical issues in the design and conduct of randomised controlled trials.

Ethical issues in the design and conduct of randomised controlled trials.

Testing drugs in pediatric populations: The FDA mandate

Ethical considerations in research involving children

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