Controlling research trials
Article Abstract:
The US Office of Human Research Protection (OHRP) must work together with the National Institutes of Health to promptly evaluate any complaints about the design and implementation of clinical trials. The OHRP continues to hold up a 2002 study of acute respiratory distress syndrome because some scientists not involved in the study said it might be unethical. A panel of experts who examined the trial's design denied the charge, but OHRP refuses to allow the trial to proceed.
Publication Name: The New England Journal of Medicine
Subject: Health
ISSN: 0028-4793
Year: 2003
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How best to ventilate? Trial design and patient safety in studies of the acute respiratory distress syndrome
Article Abstract:
A doctor who has interviewed both sides gives a complete and detailed analysis of the discontinuation of a study by the Acute Respiratory Distress Syndrome Network. The study was stopped in July, 2002, after the US Office for Human Research Protection objected to its design. It did so because two doctors at the National Institutes of Health believed that a previous study by the same group may have subjected the patients participating in the trial to unnecessary risk.
Publication Name: The New England Journal of Medicine
Subject: Health
ISSN: 0028-4793
Year: 2003
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Statistics in medicine-reporting of subgroup analyses in clinical trials
Article Abstract:
The challenges related to conducting and reporting subgroup analyses are discussed.
Publication Name: The New England Journal of Medicine
Subject: Health
ISSN: 0028-4793
Year: 2007
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