3 ms·

Two cancer drug trials put on hold after patients died, companies say

8 points by LinuxBender 3y ago

paulpauper 3y ago
The two trials were unrelated: They were in different stages and testing therapies. But both were testing new cancer treatments. One was testing a treatment for a blood cancer called acute myeloid leukemia, or AML, and the other was testing a new agent for ovarian cancer. Deaths in clinical trials are thought to be rare. how is it rare or unexpected when the cancers have a near certain mortality rate for patients whose illnesses have progressed to the point of needing to enroll in a trial, which is often for terminal patients? We're not talking a clinical trial for hair loss.
- justsomehnguy 3y ago
  > Mersana said Thursday that the FDA had issued a partial clinical hold after five study participants had fatal bleeding events, a rate that was higher than would have been expected. About 560 people have taken the study drug to date, the company said. Because if you write "0.5% deaths with unexpected circumstances triggered FDA to do what it should do" wouldn't be so clickbaity.
notjulianjaynes 3y ago
I found it strange that the claim that "deaths in clinical trials are thought to be rare" was backed up with a study from Germany, since this involves the United States FDA. After some non-expert searching I could not find a more relevant source either, possibly owing to a lack of "unambiguous and complete reporting of the number of deaths in trial registries and publications" [1]. A watchdog group's lawsuit against the FDA claims that from 2014-2017 there were 150 deaths related to clinical trials [2] but I am not certain how reliable that figure is. [1] https://bmjopen.bmj.com/content/3/1/e001963 https://bmjopen.bmj.com/content/3/1/e001963 [2] https://www.clinicalleader.com/doc/clinical-trial-deaths-will-clearer-informed-consent-documents-be-enough-0001 https://www.clinicalleader.com/doc/clinical-trial-deaths-wil...

3 ms·

Two cancer drug trials put on hold after patients died, companies say

8 points by LinuxBender 3y ago

paulpauper 3y ago
The two trials were unrelated: They were in different stages and testing therapies. But both were testing new cancer treatments. One was testing a treatment for a blood cancer called acute myeloid leukemia, or AML, and the other was testing a new agent for ovarian cancer. Deaths in clinical trials are thought to be rare. how is it rare or unexpected when the cancers have a near certain mortality rate for patients whose illnesses have progressed to the point of needing to enroll in a trial, which is often for terminal patients? We're not talking a clinical trial for hair loss.
- justsomehnguy 3y ago
  > Mersana said Thursday that the FDA had issued a partial clinical hold after five study participants had fatal bleeding events, a rate that was higher than would have been expected. About 560 people have taken the study drug to date, the company said. Because if you write "0.5% deaths with unexpected circumstances triggered FDA to do what it should do" wouldn't be so clickbaity.
notjulianjaynes 3y ago
I found it strange that the claim that "deaths in clinical trials are thought to be rare" was backed up with a study from Germany, since this involves the United States FDA. After some non-expert searching I could not find a more relevant source either, possibly owing to a lack of "unambiguous and complete reporting of the number of deaths in trial registries and publications" [1]. A watchdog group's lawsuit against the FDA claims that from 2014-2017 there were 150 deaths related to clinical trials [2] but I am not certain how reliable that figure is. [1] https://bmjopen.bmj.com/content/3/1/e001963 https://bmjopen.bmj.com/content/3/1/e001963 [2] https://www.clinicalleader.com/doc/clinical-trial-deaths-will-clearer-informed-consent-documents-be-enough-0001 https://www.clinicalleader.com/doc/clinical-trial-deaths-wil...