Word: trialing
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...addition to showing that the vaccine can prolong remission, Bendandi's trial attempted to solve the long-standing problem of quantifying the results of custom-made treatments. Advanced drug trials require a control group, one whose members share key characteristics with those in the experimental arm, but who receive a placebo or another treatment rather than the one under study. According to Bendandi, randomized testing of custom-made vaccines would be meaningless because each patient in the experimental arm receives a different treatment. So he set about proving efficacy in another way. "The course of the study design...
...everyone is convinced by that logic. Dr. Robert Schwartz, an editor at the New England Journal of Medicine, says, "Using patients as their own control is a bit shaky, especially for follicular lymphoma." A Phase III randomized trial, more difficult but still possible to conduct even with customized vaccines remains, he says, "the gold standard for proof of efficacy." Dr. Kwak, who is conducting his own Phase III trial of a vaccine for the American pharmaceutical company Biovest, believes his former trainee's results support the case for a therapeutic lymphoma vaccine, but is skeptical about his methods. "Dr. Bendandi...
Especially among the researchers developing them. "My trial was designed to have every chance to fail," says Bendandi. "If just one patient relapsed while receiving the vaccine, it would have been over. I would have needed a new job," he jokes. But the Italian-born physician is still working. In a few weeks he starts his new study, which is designed to test the vaccine's effectiveness in follicular lymphoma patients with an especially poor prognosis. Bendandi plans to administer the vaccine to participants until they relapse or die from a cause other than lymphoma. "This time," he says...
Middlesex Superior Court Judge Regina L. Quinlan’s 2005 decision to reconsider previously inadmissible evidence, based on a post-trial SJC reinterpretation of the state’s self-defense law, was appealed by the prosecution this January...
...Cave is celebrating her daughter's 23rd birthday by lobbying Texas legislators and hoping that by the time an alleged accomplice goes on trial this summer, the counseling program will be in place. "Jennifer is gone, but the life she had remains," Cave says. "I tried to give everything in my heart to those jurors, and it would be a travesty if we don't take care of them. But as they say, tragedy is often the catalyst for change...