Are Controlled Clinical Trials Really Ethical?

In: Business and Management

Submitted By JosieWilliams
Words 2973
Pages 12
Are Controlled Clinical Trials Really Ethical?
Case Study In 2009, two cousins, Thomas and Brandon were diagnosed with the same type of deadly skin cancer within a 2 month time frame of each other. To date, here is no cure for skin cancer and once diagnosed the average life expectancy is approximately 8 months. Current standard of care treatments are aimed at shrinking the tumors and prolonging life. Unfortunately, these standard of care treatments only work in a very small percentage of patients and are very toxic with terrible side effects. Thomas learned of a new Phase 3 clinical research trial sponsored by Roche with an unapproved yet promising drug. His doctor explained that in earlier trials, a majority of volunteer patients who took the wonder drug had seen a drastic reduction in the size of their tumors with very few side effects. The only way ill patients can get the drug is by participating in this trial. The trial is a randomized controlled trial (RCT) which means half of the volunteers will get the experimental drug while the other half will be treated with another standard of care treatment. The purpose of the standard or control arm is to allow researchers to compare the long term effects of the new drug to that of the current standard treatment and determine whether it actually shrinks tumors and prolong remissions. Participants have a 50/50 chance of being placed in either arm of the study. Arm assignments are random and cannot be changed. With limited options, Thomas signed up for the trial. He was randomized to the wonder drug arm and after 2 months saw his tumors shrink. Thrilled with these results, he urged Brandon to sign up for the trial as well which he did. By luck of the draw, Brandon is assigned to the standard of care treatment arm. During treatment, Brandon’s tumors continued to grow and he was in excruciating of pain. Tragically, he…...

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