INTERNATIONAL, PRAGMATIC, AND MULTISITE TRIALS: DESIGN, IMPLEMENTATION AND ETHICAL CONSIDERATIONS

Implementation considerations for multisite clinical trials with cognitive neuroscience tasks.

Multisite clinical trials aimed at cognitive enhancement across various neuropsychiatric conditions have employed standard neuropsychological tests as outcome measures. While these tests have enjoyed wide clinical use and have proven reliable and predictive of functional disability, a number of implementation challenges have arisen when these tests are used in clinical trials. These issues are ...

Cluster randomised trials : Methodological and ethical considerations

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...

Multisite international collaborative clinical trials in mania.

Gustavo Vázquez, Ross J. Baldessarini, Ayşegül Yildiz, Jorge Tamayo, Leonardo Tondo and Paola Salvatore 1 Department of Neuroscience, Palermo University, Buenos Aires, Argentina 2 International Consortium for Bipolar Disorder Research, McLean Hospital, Belmont, MA, USA 3 Department of Psychiatry, Harvard Medical School, Boston, MA, USA 4 Department of Psychiatry, Dokuz Eylül University, Izmir, ...

Ethical considerations in AIDS vaccine trials.