In some my readings of late, clinical trials have been put on hold or will not accept new patient enrollment due to budget impact on FDA. Anybody got any credible info as to whether this one is going to continue at its current pace - or is there going to be a snag if the budget/debt problem is not resolved very soon?
Currently I am involved in an IDE FDA study. The study is funded by the company and the government shutdown has nothing to due with enrollment. Quit coming on this board lying about your fabricated delusions.
Would not expect this since the company runs the clinical trials, not the FDA. Perhaps one might need the FDA for certification of new sites or inspection of manufacturing, but REDUCE-IT is substantially underway and does not need these type of GLP/GMP certs at present. It could affect a committee that looks at interim data I suppose, but I don't think they are at that point yet. I am also under the impression that the Pharma pays the FDA administration costs under PDUFA so they don't require Govt funding to keep the trial going.
If a clinical study is backed by or funded by a US Federal Government entity, such as the National Cancer Institute or some other branch of the National Institutes of Health, the study may be delayed. It's hard to be sure what will happen In any particular case, it will depend on the length of the shutdown. REDUCE-IT is 100% operated and funded by Amarin, an Irish company with operations in the US. There is no problem.