I am writing to ask the ASCO community for help in addressing a policy decision by the Nuclear Regulatory Commission (NRC) that requires oncologists to take a 700-hour course (on the full range of nuclear medicines) to give one medicine to their patients: prepackaged radioimmunotherapy. It’s...
In a previous issue of The ASCO Post, Dr. Susan O’Brien wrote, “It is my understanding that the FDA strongly opposed allowing crossover [in the RESONATE trial]. I presume that is because the FDA also wants to see if there is a survival advantage.”1 The lack of crossover seems a valid concern to me...
The Clinical Trials and Translational Research Advisory Committee (CTAC) of the National Cancer Institute (NCI) met for the 22nd time on March 12, 2014, in their ongoing effort to improve efficiency and effectiveness of cancer clinical trials. A significant portion of the meeting addressed lagging...