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How to Test More Drugs
Some personal takeaways from organizing a workshop focused on policies for making clinical trials cheaper and faster.
To this end we invited experts, including Sir Martin Landray, co-lead of the RECOVERY trial, which uncovered the effectiveness of existing drugs (e.g. dexamethasone) in record time and with relatively low costs. An investigator shall seek informed consent only under circumstances that provide the prospective subject or the legally authorized representative sufficient opportunity to discuss and consider whether or not to participate and that minimize the possibility of coercion or undue influence [emphasis added]. The massive amount of undocumented specialist knowledge that you need to efficiently run a clinical development program strongly favors incumbents, preventing new market entrants from easily competing on the basis of cost or competenceーe.g., it doesn’t matter if your firm has 170 IQ engineers if they simply don’t know all the One Weird Tricks about how to get around the FDA’s catch-22s.
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