Replies to post #373846 on NorthWest Biotherapeutics Inc (NWBO)

[anders2211]

to what article are you referring to when you speak of "the article"?

The article further stated that only 13.4 % of drug trial results are disclosed within the 1yr time frame and only 50.5% are disclosed within 5 yrs of trial completion.

I have very different numbers than you so provide a link to your source.

https://pubmed.ncbi.nlm.nih.gov/31958402/

4209 trials were due to report results; 1722 (=41%) did so within the 1-year deadline. 2686 (63·8%) trials had results submitted at any time. Compliance has not improved since July, 2018. Industry sponsors were significantly more likely to be compliant than non-industry, non-US Government sponsors (odds ratio [OR] 3·08 [95% CI 2·52-3·77]), and sponsors running large numbers of trials were significantly more likely to be compliant than smaller sponsors (OR 11·84 [9·36-14·99]). The median delay from primary completion date to submission date was 424 days (95% CI 412-435), 59 days higher than the legal reporting requirement of 1 year.

I know the FDA rule is poorly enforced I am not pretending that my email would chance anything still perhaps it has some influence. By the way, I could have much bigger consequences for NWBO than just a big fine

Failure to report the results of a clinical trial can distort the evidence base for clinical practice, breaches researchers' ethical obligations to participants, and represents an important source of research waste. The Food and Drug Administration Amendments Act (FDAAA) of 2007 now requires sponsors of applicable trials to report their results directly onto ClinicalTrials.gov within 1 year of completion. The first trials covered by the Final Rule of this act became due to report results in January, 2018. In this cohort study, we set out to assess compliance