Health and Medicine

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1. Please read the following published journal articles: Fernandes, R. M., van der Lee, J. H., & Offringa, M. (2009). A systematic review of the reporting of Data Monitoring Committees’ roles, interim analysis, and early termination in pediatric clinical trials. BMC pediatrics, 9, 77. https://doi.org/10.1186/1471-2431-9-77 Links to an external site. (Download the PDF). Breteler M. M. (1998). Selegiline, or the problem of early termination of clinical trials. The clinical questions are not well answered, and probably never will be. BMJ (Clinical research ed.), 316(7139), 1182–1183. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC1112980/ Links to an external site. (Download the PDF). (NOTE: PLEASE START READING FROM PAGE 1182). 2. Please watch the following videos: • o Study Finds Its Bad Medicine to Stop Clinical Trials Early https://www.youtube.com/watch?v=82_ZBC_b7bw Links to an external site. • o Reasons to Not Stop Trials Early https://www.youtube.com/watch?v=vbk54Y9DPZQ Links to an external site. • o Update on Early Stoppage in Clinical Trials https://www.youtube.com/watch?v=vm9h2GSX_wo Links to an external site. Question 1: Suppose a clinical trial shows that the new drug gives much better results than the placebo or the standard treatment. Why might it not be a good idea to stop the trial at the point where good results are found? Question 2: Provide and discuss the advantages of stopping a clinical trial when a clear statistical advantage is found for the new drug. Discuss the disadvantages of stopping at that point.

 

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