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Category Archives: International and National Clinical Research

Just When You Thought It Couldn’t Be Worse. A Look Behind the Scenes

February 2, 2017

The results of clinical research studies are often published without details of the scientific and ethical discussions that precede their final approval. The Children with HIV Early Antiretroviral Therapy (CHER) study initiated in 2005 and conducted in South Africa is a case in point.1 The study sought to evaluate immediate versus delayed treatment of infants …more»

The Clock Keeps Ticking

September 19, 2016

Just how long should the wait be before assuming that an answer to an important question will never be provided? It depends of course on the importance of the issue and the credibility of both the individual who is asking the question and the individual who is supposed to respond. In a letter written on …more»

Is Anyone Listening?

September 12, 2016

In July, 2016 a letter was sent to 14 Institutional Review Boards (IRBs) declaring that they had incorrectly approved a study of VRC01 HIV monoclonal antibody in infants at high risk of HIV infection. The study would withhold lifesaving treatment from the infants until after the experimental monoclonal antibody was administered. Several IRBs replied that …more»

Truth In Advertising. Global Health Implications.

August 12, 2016

Perhaps it is not advertising in the strictest sense of the term but when WHO puts out their five-year goals for ending the HIV epidemic it is communicating two things— a sincere call to bring the largest sexually transmitted infectious disease epidemic in modern history under control and, the need for funding to do it. …more»

Too Many Research Products. Too Few Research Volunteers. Ethical Implications

August 3, 2016

The financial and infrastructure investment in clinical research over the past several decades has resulted in major benefits to the health of individuals in both wealthy and poor countries. The ability to identify the cause of disease and develop treatments to control and even eradicate disease is a testimony to the investment in clinical research …more»