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Adaptive Designs for Clinical Trial

Randomized clinical trials serve as the standard for clinical research and have contributed immensely to advances in patient care. Nevertheless, several shortcomings of randomized clinical trials have been noted, including the need for a large sample size and long study duration, the lack of power to evaluate efficacy overall or in important subgroups, and cost. These and other limitations have been widely acknowledged as limiting medical innovation.1 Adaptive trial design has been proposed as a means to increase the efficiency of randomized clinical trials, potentially benefiting trial participants and future patients while reducing costs and enhancing the likelihood of finding a true benefit, if one exists, of the therapy being studied.

Citado: Bhatt DL, Mehta C. Adaptive Designs for Clinical Trials. N Engl J Med [Internet]. 2016 [citado 7 Nov 2017];375(1).

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Assessing the Gold Standard — Lessons from the History of RCTs

Over the past 70 years, randomized, controlled trials (RCTs) have reshaped medical knowledge and practice. Popularized by mid-20th-century clinical researchers and statisticians aiming to reduce bias and enhance the accuracy of clinical experimentation, RCTs have often functioned well in that role. Yet the past seven decades also bear witness to many limitations of this new “gold standard.” The scientific and political history of RCTs offers lessons regarding the complexity of medicine and disease and the economic and political forces that shape the production and circulation of medical knowledge.

Citado: Bothwell LE, Greene JA, Podolsky SH, Jones DS. Assessing the Gold Standard– Lessons from the History of RCTs. N Engl J Med [Internet]. 2016 [citado 7 Nov 2017];374(22).

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