6 ms·
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
by 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...