<story><title>Why Are Clinical Trials So Complicated?</title><url>https://blogs.sciencemag.org/pipeline/archives/2020/05/01/why-are-clinical-trials-so-complicated</url></story><parent_chain></parent_chain><comment><author>gumby</author><text>Having designed and run clinical trials and combo manufacturing (drug + device) in my past I can testify that this is right on.  There&amp;#x27;s a huge effort (pushed by the FDA back on the manufacturer) to isolate variables and to ensure that whatever you want to say about your product you have actually verified to their satisfaction.  As a person who also takes medication I&amp;#x27;m glad about it.&lt;p&gt;I also don&amp;#x27;t think people should harsh on the FDA because of their strictness.  There&amp;#x27;s a lot of gaming attempted in dealing with them which makes them harder to work with, but in my experience they&amp;#x27;ve been pretty decent to deal with.  Of course we had a policy of &lt;i&gt;no&lt;/i&gt; attempting to game the system.</text></comment>
<story><title>Why Are Clinical Trials So Complicated?</title><url>https://blogs.sciencemag.org/pipeline/archives/2020/05/01/why-are-clinical-trials-so-complicated</url></story><parent_chain></parent_chain><comment><author>choxi</author><text>&amp;gt; The amount of noise in human clinical data can defy belief if you haven’t seen it in person&lt;p&gt;I&amp;#x27;m not surprised that patient compliance is a problem, but it still seems like an expensive burden to find patients physically near the clinical trials so they can come in to take the medication. It just seems like a logistical nightmare that software could help with.&lt;p&gt;Could you build an app that requires patients to record themselves taking their medication under whatever conditions they&amp;#x27;re supposed to? You might have to manually audit all of the recordings, but the number of people that still fail to comply might be offset but how many more patients you can include in the study. There might be a lot of other things you could verify remotely using wearable tech, e.g. heart rate now that Apple&amp;#x27;s EKG monitoring is FDA approved.&lt;p&gt;Great read, I&amp;#x27;d like to see more &amp;quot;Chesterton&amp;#x27;s Fence&amp;quot; arguments for other highly regulated industries.</text></comment>