CLINICAL TRIALS – Human clinical trials are an important last hurdle in the development of new drugs and therapies. Today, The Conversation takes a closer look at this vital scientific endeavour with three articles that look at different aspects of the process.
Two large US-funded studies on cervical cancer screening in India are being investigated by the US Office of Human Research Protection for ethical violations. Concerns were raised about the trials after a large number of women in the control groups died from cervical cancer.
One of the studies was sponsored by the US National Cancer Institute (NCI) and the other by the Bill and Melinda Gates Foundation. Both aimed to compare the efficiency and success rates of different methods of cervical cancer screening.
Cervical cancer is the second most common cancer in women worldwide. About 86% of cases occur in low-income countries, mainly due to the lack of widespread screening programs that usually detect pre-cancerous symptoms. In India, the disease kills more than 70,000 women each year.
The routine detection of pre-cancerous cells in high-income countries is through Pap smears, but they require more money and expertise than is available in most low-income nations.
The issues raised by complaints about the trials echo ongoing debates within bioethics communities. The first relates to the quality and validity of consent given by participants, and the second to the standard of care provided to control groups. The control groups included more than 76,000 women, and at least 98 of them have died since the studies began.
The views, opinions and positions expressed by these authors and blogs are theirs and do not necessarily represent that of the Bioethics Research Library and Kennedy Institute of Ethics or Georgetown University.