Clinical trials waiver in India-some considerations

Gastroenterology in India - some considerations.

The European brand of research universities, in the early twentieth century, became the role model for American Universities such as Harvard and Cornell [1]. Countries like India and China with rapidly growing economies need such role-models. India with a population of 1.2 billion is struggling to organize its research and Hepatogastroenterology (HGE) training, and to meet the requirements of n...

Multi-arm clinical trials of new agents: some design considerations.

A major challenge in the development of anticancer therapies is the considerable time and resources needed for conducting randomized clinical trials (RCT). There is a need for more efficient RCT designs that accelerate development, minimize costs, and make trials more appealing to patients. We review the statistical and logistical characteristics of multi-arm designs that compare several experi...

Ethical Considerations in Clinical Trials

Accessible online at: www.karger.com/journals/hed Ethical aspects of biomedical research in humans have been unmasked at a late stage in the history of science. They have been apparent for not more than approximately 60 years, and did not gain attention as a result of ongoing refinements of fundamental human rights. On the contrary, their recognition followed a traditional pattern in the histor...

Considerations on Subgroup Analyses in Clinical Trials.

As clinicians, we routinely treat patients with drugs whose efficacy is supported by evidence from multicenter clinical trials, some of which include thousands of patients from different parts of the world. When it comes to treating a given patient, however, we need to know whether the beneficial effect described for the average patient will apply to this patient in particular. This can be done...

Clinical Trials Registry--India: redefining the conduct of clinical trials.