Why are clinical trials so expensive? Tales from the beast’s belly
I worked at a small-to-mid-size clinical research organization for a hot minute. That company had its own set of - let&#x27;s say &quot;unique&quot; - problems*, but the author touched on many of the issues I saw in my short experience at a CRO. I was in an odd (for me), pseudo-managerial, HR-type role at the company (a role in which I&#x27;ll be the first to admit I wasn&#x27;t good at) so perhaps I can offer some additional perspective.<p>But first, I want to give some background on an important part of the CRO world: the &quot;clinical research associate&quot; or &quot;CRA&quot;. CRAs are are the CRO&#x27;s meat-and-potatoes, boots-on-the-ground, core, etc. after contracts have been signed. A CRA is the person who actually goes to clinical trial &quot;sites&quot; (e.g. a doctor&#x27;s office, a hospital, or, even a dedicated facility for clinical trial participants). The CRA goes to each trial site, talks to the doc, makes sure participant recruitment is going well, checks&#x2F;writes documentation, and follows up as the trial goes on. In other words, the performance of the CRAs strongly &amp; directly affects the performance of the clinical trial.<p>Anyway, my top issues with clinical trials today are:<p>(1) Poor patient recruitment - this is a major problem. There is, of course, lots of variability between trials and CROs with respect to recruitment, but it should be telling that &quot;trial rescue&quot; is often done (at least where I worked) as a result of the incumbent CRO&#x27;s inability to recruit enough patients.<p>(2) (Related) Limiting pay to study participants: although it&#x27;s up to the institutional review board&#x27;s interpretation (IRB, an ostensibly independent entity that&#x27;s supposed to sign off on the trial&#x27;s ethics), good clinical practice (GCP) guidelines states that paying participants too much would be &quot;undue influence&quot;. I have no idea how this plays out in practice, but I think it&#x27;s a bad guideline. Most of the other parts of GCP are good things - stuff like informed consent and not coercing subjects - but this one is (again, in my opinion) probably raising trial costs through recruitment delays or total non-recruitment, even accounting for the extra cost of paying participants more.<p>(3) Clinical Research Associate (CRA) training &amp; hiring: this isn&#x27;t unique to the CRO industry but it seems like a bigger problem than in other industries. I&#x27;ve seen US median salary ranges from $70,000 to $120,00 from publicly available sources but my time in the industry rarely demonstrated numbers that high. Although CRAs don&#x27;t treat patients directly, it is a role that requires medical knowledge, attention to detailed paperwork, and good communication skills. There seemed to be a lot of cutting corners on training &amp; hiring CRAs - e.g. hiring highly experienced CRAs from India and putting them into entry-level roles in the US on the cheap. I don&#x27;t mean to say there aren&#x27;t great experienced CRAs from India who are also great when dropped into an entry-level CRA role but doing so as a matter of unofficial policy is a bad idea: India&#x27;s drug industry has a different regulatory environment (although there is significant cooperation between FDA and Indian manufacturing facilities) and, perhaps more importantly, there will be a wide variation in communication skills simply because english is a second language (or, in the case of India in particular, &quot;Indian english&quot; has taken on a life of its own).<p>(4) Over-promising, under-delivering - true of any contractor even outside the CRA industry. Even when working on a fixed price basis, there are perpetual &quot;change orders&quot; and arguments over change orders.<p>Side-note: if you want to learn more about the process by which drugs come to market, I strongly recommend <i>New Drugs</i> by Lawrence T. Friedhoff. It&#x27;s short and the HN crowd won&#x27;t have any problem understanding. Amazon link: <a href="https:&#x2F;&#x2F;www.amazon.com&#x2F;New-Drugs-Insiders-Scientists-Investors&#x2F;dp&#x2F;141969961X" rel="nofollow">https:&#x2F;&#x2F;www.amazon.com&#x2F;New-Drugs-Insiders-Scientists-Investo...</a><p>* &quot;Unique&quot; problems in the sense that they were personality-based. I won&#x27;t go into specifics nor do I wish to speak negatively of my prior employer who, to their credit, took a chance on me that just happened to not work out. But I will give some general advice: if, during a job interview or in early conversations, senior management insults his&#x2F;her own family <i>and</i> dumpsters their own employees, you&#x27;re going to have a bad time.