Details

Autor(en) / Beteiligte

• Ohman, E. Magnus, MD
• Roe, Matthew T., MD, MHS
• Armstrong, Paul W., MD
• Fox, Keith A., MB, ChB
• Prabhakaran, Dorairaj, MD
• White, Harvey D., DSc

Titel

Public Sensationalism and Clinical Trials: How to Address the Challenges of Science?

Ist Teil von

• The American journal of medicine, 2010-06, Vol.123 (6), p.481-483

Ort / Verlag

United States: Elsevier Inc

Erscheinungsjahr

2010

Link zum Volltext

Quelle

MEDLINE

Beschreibungen/Notizen

• In recent years, some trials have encountered rare and unexpected events that modulate future conduct of the trial. Occasionally this has led to unblinding of a trial or even refusal by some institutional review boards to proceed. Rare events that are not part of the primary end point or unexpected safety concerns can be difficult to assess. If an unexpected side effect emerges, which is unlikely if the trial is based on the best existing knowledge of science, it may be unclear whether it simply represents a random observation or a genuinely new finding attributable to the study intervention. In the latter situation, it may be appropriate to unblind a trial or suspend, at least temporarily, further patient enrollment. Here, Ohman et al discuss how to address the challenges in clinical trials.