3 ms·

Can you give an example of unethical trials where “there was no viable alternative” was what got the trial past an IRB? I’m more familiar with inverse complaint

Can you give an example of unethical trials where “there was no viable alternative” was what got the trial past an IRB? I’m more familiar with inverse complaints that trials are blocked by red tape and hypothetical concerns that are objectively small in actual QALY harm. (I’m sure this varies by jurisdiction too; I have only heard bad thing about US IRBs)

justahuman74 3y ago
I'd have assumed it was when they give sick people the placebo when they have a reasonable hunch (but not a published study that people trust) that the real medication would actually save them
Gatsky 3y ago
IRBs do not evaluate the value of a research endeavour. They are in fact unable to do this due to lack of knowledge and expertise. They approve trials which fit the mold of trials they have seen before. Why does a clinical trial get done? The main reason is that someone, usually a pharmaceutical or device company, is willing to pay for it. Some recent examples of problems with clinical trials: 1. Using a harmful or deliberately inadequate placebo. https://academic.oup.com/jnci/article/104/4/273/979399 https://academic.oup.com/jnci/article/104/4/273/979399 https://www.ahajournals.org/doi/10.1161/CIRCULATIONAHA.122.059410 https://www.ahajournals.org/doi/10.1161/CIRCULATIONAHA.122.0... https://pubmed.ncbi.nlm.nih.gov/34688044/ https://pubmed.ncbi.nlm.nih.gov/34688044/ 2. Starting a bunch of clinical trials using a biomarker which turned out to be invalid. https://www.nejm.org/doi/10.1056/NEJMoa1214271 https://www.nejm.org/doi/10.1056/NEJMoa1214271 3. Endless 'me-too' trials driven by pharma, with a low chance of success. https://www.statnews.com/2019/09/04/me-too-drugs-cancer-clinical-trials/ https://www.statnews.com/2019/09/04/me-too-drugs-cancer-clin...

3 ms·

Can you give an example of unethical trials where “there was no viable alternative” was what got the trial past an IRB? I’m more familiar with inverse complaint

by theptip 3y ago

justahuman74 3y ago
I'd have assumed it was when they give sick people the placebo when they have a reasonable hunch (but not a published study that people trust) that the real medication would actually save them
Gatsky 3y ago
IRBs do not evaluate the value of a research endeavour. They are in fact unable to do this due to lack of knowledge and expertise. They approve trials which fit the mold of trials they have seen before. Why does a clinical trial get done? The main reason is that someone, usually a pharmaceutical or device company, is willing to pay for it. Some recent examples of problems with clinical trials: 1. Using a harmful or deliberately inadequate placebo. https://academic.oup.com/jnci/article/104/4/273/979399 https://academic.oup.com/jnci/article/104/4/273/979399 https://www.ahajournals.org/doi/10.1161/CIRCULATIONAHA.122.059410 https://www.ahajournals.org/doi/10.1161/CIRCULATIONAHA.122.0... https://pubmed.ncbi.nlm.nih.gov/34688044/ https://pubmed.ncbi.nlm.nih.gov/34688044/ 2. Starting a bunch of clinical trials using a biomarker which turned out to be invalid. https://www.nejm.org/doi/10.1056/NEJMoa1214271 https://www.nejm.org/doi/10.1056/NEJMoa1214271 3. Endless 'me-too' trials driven by pharma, with a low chance of success. https://www.statnews.com/2019/09/04/me-too-drugs-cancer-clinical-trials/ https://www.statnews.com/2019/09/04/me-too-drugs-cancer-clin...