There’s a lot to be said about the seemingly overbearing nature of the majority of FDA/ISO standards that result in the mass amount of hurdles that need to be jumped before a treatment is available, but that’s mainly due to institutional trauma from past events (thalidomide, primarily) as well as the fact that treatments are not simply binary. The options are not just “does not work” and “makes patient better,” there’s also “makes the problem worse.” These additional tests and trials are to catch and prevent adverse effects just as much as they are to ensure the drug or treatment actually works.