Al's Comment:

 These authors make an excellent point:  The clinical trials system needs to be updated.  We should create a standardized database - perhaps using clinicaltrials.gov - to hold the patient level data in a trial.  The control groups' de-identified data should be available to researchers to use for external contemporaneous control groups.  Most trials do not accrue completely - too many lives are wasted in a control group, when this database could eliminate or minimize the need for control groups.    The FDA should scrutinize clinical trial design and make suggestions at the start. In practice, they seem to rubber stamp trial design at the start, but then when it comes time for approval, they rip apart the trial design that they originally approved.   Perhaps trial designs should go before a board of neuro-oncologists which help transform the trial into a better design so we do not waste lives.


Posted on: 02/10/2023

A Critical Analysis of Neuro-Oncology Clinical Trials 

 


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