Risk, Helsinki 2000 and the use of placebo in medical research

Saunders, John; Wainwright, Paul

doi:10.7861/clinmedicine.3-5-435

Cited by 24 publications

(18 citation statements)

References 12 publications

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“…1 Use of placebos in clinical trials has been the subject of intense debate. [2][3][4][5][6][7][8][9][10][11][12][13][14][15][16][17] Arguments have centered on defining the scientific and ethical circumstances-if any-that justify use of placebo controls.…”

mentioning

confidence: 99%

Prevalence and factors associated with use of placebo control groups in randomized controlled trials in psoriasis: A cross-sectional study

Katz¹,

Karlawish²,

Chiang³

et al. 2006

Journal of the American Academy of Dermatology

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mentioning

confidence: 99%

Prevalence and factors associated with use of placebo control groups in randomized controlled trials in psoriasis: A cross-sectional study

Katz¹,

Karlawish²,

Chiang³

et al. 2006

Journal of the American Academy of Dermatology

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“…Use of placebo was deemed justifiable for compelling and scientifically sound methodological reasons or when the therapy being investigated is for a minor condition. Saunders and Wainwright [46] examine other blanket statements against the use of placebo and oppose these as simplistic.…”

Section: Clinical Trialsmentioning

confidence: 97%

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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“…In the Edinburgh (2000) revision of the Declaration of Helsinki [20,21] towards the "middle ground" [22] .…”

Section: Ethical Issues In Human Research: the Revision Of The Declarmentioning

confidence: 99%

Challenges in randomized controlled trials and emerging multiple sclerosis therapeutics

Huang¹

2015

Neurosci. Bull.

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The remarkable global development of disease-modifying therapies (DMTs) specific for multiple sclerosis (MS) has signifi cantly reduced the frequency of relapse, slowed the progression of disability, and improved the quality of life in patients with MS. With increasing numbers of approved DMTs, neurologists in North America and Europe are able to present multiple treatment options to their patients to achieve a better therapeutic outcome, and in many cases, no evidence of disease activity. MS patients have improved accessibility to various DMTs at no or minimal out-of-pocket cost. The ethical guidelines defi ned by the Edinburgh revision of the Declaration of Helsinki strongly discourage the use of placebo control groups in modern MS clinical trials. The use of an active comparator control group increases the number of participants in each group that is essential to achieve statistical signifi cance, thus further increasing the diffi culty of completing randomized controlled trials (RCTs) for the development of new MS therapies. There is evidence of a high prevalence of MS and a large number of patients in Asia. The belief of the existence of Asian types of MS that are distinct from Western types, and regulatory policies are among the reasons why DMTs are limited in most Asian countries. Lack of access to approved DMTs provides a good opportunity for clinical trials that are designed for the development of new MS therapies. Recently, data from RCTs have demonstrated excellent recruitment of participants and the completion of multi-nation and single-nation MS trials within this region. Recent studies using the McDonald MS diagnostic criteria carefully excluded patients with neuromyelitis optica (NMO) and NMO spectrum disorder, and demonstrated that patients with MS in Asia have clinical characteristics and treatment responses similar to those in Western countries.

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Risk, Helsinki 2000 and the use of placebo in medical research

Cited by 24 publications

References 12 publications

Prevalence and factors associated with use of placebo control groups in randomized controlled trials in psoriasis: A cross-sectional study

Prevalence and factors associated with use of placebo control groups in randomized controlled trials in psoriasis: A cross-sectional study

Ethical considerations in research involving children

Challenges in randomized controlled trials and emerging multiple sclerosis therapeutics

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