Placebo response in studies of major depression: variable, substantial, and growing

BT Walsh, SN Seidman, R Sysko, M Gould - Jama, 2002 - jamanetwork.com
ContextIntense debate persists about the need for placebo-controlled groups in clinical trials
of medications for major depressive disorder (MDD). There is continuing interest in the …

Informed consent and the elusive dichotomy between standard and experimental therapy

L Noah - American Journal of Law & Medicine, 2002 - cambridge.org
A rich academic literature exists about issues of informed consent in medical care, and, to a
lesser extent, about a variety of issues posed by human experimentation. Most …

What makes placebo-controlled trials unethical?

FG Miller, H Brody - The American Journal of Bioethics, 2002 - Taylor & Francis
The leading ethical position on placebo-controlled clinical trials is that whenever proven
effective treatment exists for a given condition, it is unethical to test a new treatment for that …

Choosing an equivalence limit for noninferiority or equivalence studies

BL Wiens - Controlled clinical trials, 2002 - Elsevier
Studies that compare treatments with the purpose of demonstrating that the treatments are
similar require an a priori definition of an equivalence limit, how different the treatments can …

National Depressive and Manic-Depressive Association consensus statement on the use of placebo in clinical trials of mood disorders

DS Charney, CB Nemeroff, L Lewis… - Archives of general …, 2002 - jamanetwork.com
A consensus conference on the use of placebo in mood disorder studies consisted of expert
presentations on bioethics, biostatistics, unipolar depression, and bipolar disorder. Work …

Placebos that harm: sham surgery controls in clinical trials

AJ London, JB Kadane - Statistical Methods in Medical …, 2002 - journals.sagepub.com
Recent debates over the use of sham surgery as a control for studies of fetal tissue
transplantation for Parkinson's disease have focused primarily on rival interpretations of the …

Placebo-controlled trials and the Declaration of Helsinki

JA Lewis, B Jonsson, G Kreutz, C Sampaio… - The Lancet, 2002 - thelancet.com
A revised version of the Declaration of Helsinki, issued in October, 2000, remains a vital
expression of medical ethics, and deserves unanimous support. A strict interpretation of the …

Ethical issues in including suicidal individuals in clinical research

CB Fisher, JL Pearson, S Kim, CF Reynolds - IRB: Ethics & Human …, 2002 - JSTOR
Although suicide was the 1 ith leading cause of death in the United States in zooo, the
number of empirically validated treatments to reduce suicidality is small. Recent reviews …

Treatment-as-usual for adolescent suicide attempters: Implications for the choice of comparison groups in psychotherapy research

A Spirito, C Stanton, D Donaldson… - Journal of Clinical Child …, 2002 - Taylor & Francis
Studied Treatment-as-Usual (TAU) in a sample of 63 adolescent suicide attempters.
Randomized clinical trials (RCT's) with high-risk populations, such as suicidal patients, are …

Placebo in clinical trials for depression: complexity and necessity

DJ Kupfer, E Frank - Jama, 2002 - jamanetwork.com
WITHIN THE LAST SEVERAL YEARS, THE LONG-simmering debate about the ethical
issues sur-rounding placebo administration in randomized clinical trials has reached new …