4 ms·

A kind of side-note, but for similar reasons, most interventional trials in the oncology space aren’t double-blinded for that reason. If you have cancer and sig

by zxexz 6y ago

A kind of side-note, but for similar reasons, most interventional trials in the oncology space aren’t double-blinded for that reason. If you have cancer and sign up for a trial, you’ve likely run out of standard treatment options, so being given a placebo in a potentially life-saving therapy is not easy to justify. The different arms of the trial tend to vary in inclusion/exclusion criteria and doses, but only very rarely is there a placebo involved.

tialaramex 6y ago
Yup. I had Hodgkins many years ago. We've been treating Hodgkins for many decades with considerable success (~95% of young men with Hodgkins eventually die of something else and that may have improved further). And so it would be unethical to perform a placebo comparison because we're confident from anecdotal evidence (some patients refuse treatment) that it'll kill you. I was considered for (but ultimately did not qualify IIRC) a trial of a new Hodgkins treatment. If I had qualified and opted in all that would have meant is basically they toss a coin, heads I get the new treatment, tails I get the existing "Gold standard". As well as not using a placebo because it's a death sentence, they also can't truly blind the trial because the new regime is different drugs, with different side effects and a different calendar. The staff must know which they are giving you and even if they didn't just tell you it's not hard to look up online what the Gold Standard is and tell if you aren't getting it. So all they have left it's a two arm trial in which they've tried to match the arms up, and then compare the results. In my case the eventual trial results show the new regime was slightly worse, not better as hoped. Slightly more (statistically insignificant but not good news) deaths and worse side effects. Unfortunate, but there was only one way to find out.

by zxexz 6y ago

tialaramex 6y ago

Yup. I had Hodgkins many years ago. We've been treating Hodgkins for many decades with considerable success (~95% of young men with Hodgkins eventually die of something else and that may have improved further). And so it would be unethical to perform a placebo comparison because we're confident from anecdotal evidence (some patients refuse treatment) that it'll kill you. I was considered for (but ultimately did not qualify IIRC) a trial of a new Hodgkins treatment. If I had qualified and opted in all that would have meant is basically they toss a coin, heads I get the new treatment, tails I get the existing "Gold standard". As well as not using a placebo because it's a death sentence, they also can't truly blind the trial because the new regime is different drugs, with different side effects and a different calendar. The staff must know which they are giving you and even if they didn't just tell you it's not hard to look up online what the Gold Standard is and tell if you aren't getting it. So all they have left it's a two arm trial in which they've tried to match the arms up, and then compare the results. In my case the eventual trial results show the new regime was slightly worse, not better as hoped. Slightly more (statistically insignificant but not good news) deaths and worse side effects. Unfortunate, but there was only one way to find out.