DD Support Board and Research Team

[Arthur]

The ethics of clinical trials for terminally ill cancer patients
https://respectfulinsolence.com/2010/09/07/the-ethics-of-clinical-trials-for-termin-1/

More care has to be taken in Phase I trials. Phase I trials usually represent the first time that a drug is ever given to human beings. The patients enrolled almost always have terminal cancer for which no further potentially curative therapies are known. It has to be remembered that the purpose of a phase I trial is not to determine if a drug is effective against cancer, but rather to evaluate its safety, determine the maximal tolerated dose, and measure toxicity. It’s nice if tumor shrinkage is observed, but not essential for the drug to be taken to the next stage, phase II trials. It’s true that patients enroll in these studies because they have some hope that they might be helped by the drug being tested. However, IRBs are very insistent that it must be emphasized to patients enrolling in phase I trials that they are unlikely to benefit from the new drug.