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Pharmacoepidemiology and "in silico" drug evaluation: Is there common ground?
Stuermer, T., Rothman, K., & Avorn, J. (2008). Pharmacoepidemiology and "in silico" drug evaluation: Is there common ground?Journal of Clinical Epidemiology, 61(3), 205-206. https://doi.org/10.1016/j.jclinepi.2007.07.006
Shortcomings of randomized trials have long been recognized by medical researchers [ 1 , 2 ]. These shortcomings include a reduced range of risk factors for the outcome among patients enrolled in preapproval trials. The reduced range enhances the validity of the trials, but the patient populations are highly selected compared with the broad range of risk factors represented among patients who are eventually treated with the drug. This restriction may reduce the generalizability of the findings from those studied to those with different baseline risks.