Roxana Mehran， M.D.
Course Director， Clinical Research Workshop
New York-Presbyterian Hospital/Columbia University Medical Center
Joint Chief Scientific Officer， Cardiovascular Research Foundation

    <International Circulation>:When you look at a clinical trial， what are some the key factors that you use to evaluate the merit of a particular trial?

    Roxana Mehran: I think it is really important and essential that when you are looking at the results of a clinical trial to see how it was designed， the hypotheses that were generated， the assumptions that were made， and the statistical analysis plan as well as the conduct of the trial itself.  We need to look at whether it was multi-centered， randomized， monitored， and conducted through multiple entities， so that it really passes the muster of a well-conducted study. I think those points are extremely essential.  One needs to really look specifically at the design of the trial and assumptions that were made for the trial， because trials are often designed to answer the questions that the sponsor wants answered in their favor.  In addition， one really needs to take a step back and look at the trial in its highest scientific vigor.