Clinical trials with poor methodological quality and inappropriate statistics: Are they ethical?

Abstract

Clinical trials are considered as gold standard for analyzing
the effi cacy of new intervention. India is becoming a hub
of clinical trials.[1] Many ethical concerns were raised for
the clinical trials taking place in India.[2,3] Many efforts
are taken for improving the ethics of clinical trials, and
one of the important steps is registry of clinical trials.[4]
Editors of 12 prominent biomedical journals of India
came together to announce that after Jan 2010, they will
consider publication of only those clinical trials that are
registered in the Clinical Trial Registry.[5] For any clinical
study and, particularly clinical trial, the two important
ethical parameters are: written informed consent from the
participants and permission from the Institutional ethics
committee. Lot of stress is given for these components
in various surveys carried out for assessing the ethical
reporting in the published literature.