Indian Journal of Medical Ethics
In 2009 Sankaranarayanan et al published their findings from a large cluster-randomized, controlled trial of a single round of HPV testing, cytology testing or visual inspection with acetic acid--with appropriate treatment for those confirmed positive--as interventions to decrease mortality from cervical cancer. The control arm did not receive any screening or treatment. Several issues are brought up through the approval and conduct of this trial, which was carried out among high-risk women in rural Maharashtra, India. Specifically, this trial offers an opportunity to further discussion around clinical equipoise, identification of primary endpoints, observation of null effects, and the informed consent process, within the context of a low-income setting. Such discourse may shed light on the necessity and manner of examining a biomedical intervention in low-income settings, when the intervention is already considered efficacious in high-income settings.