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Joy and Spiritual Survival - By President Russell M. Nelson
A noninferiority study design is increasingly being used to evaluate the safety of new therapeutics. A particular challenge in noninferiority design for safety studies is that there are usually no reasonable data to justify the margin for safety. Instead, the study’s clinical advisors must decide what level of adverse events is acceptable. That level might vary according to the severity of the events, the absolute risk for the patient population, and the expected benefit of the treatment in question. In the PRECISION (Prospective Randomized Evaluation of Celecoxib Integrated Safety versus Ibuprofen or Naproxen) trial, which evaluated the noninferiority of celecoxib to naproxen for the treatment of arthritis, a relative margin of 1.33 was chosen on the basis of an expected annualized risk of 2% for the primary composite end point of death from cardiovascular causes (including hemorrhage), nonfatal myocardial infarction, or nonfatal stroke. Although this was a three-group trial, the third group did not receive placebo but instead received ibuprofen, as a second noninferiority comparator for celecoxib. During the 10-year study period, the rate of treatment discontinuation was nearly 80%, showing that drug trials may also be susceptible to incomplete treatment adherence. Nonetheless, in both the primary intention-to-treat analyses and secondary “on treatment” analyses, celecoxib was noninferior to naproxen and to ibuprofen.
Clinical Trials | Covance - Contract Research …
Keeping this in mind, I have seen our clients learn to encourage, push, challenge the people around them to get them to continue trying. Many times in business it is difficult to see, just like being blindfolded. Success, in part, for everyone at all levels is realizing that many times blindfolds are part of life and you can accomplish more by continuing to strive instead of complaining about not being able to see immediate success.