I worked at a small-to-mid-size clinical research organization for a hot minute. That company had its own set of - let's say "unique" - 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'll be the first to admit I wasn't good at) so perhaps I can offer some additional perspective.
But first, I want to give some background on an important part of the CRO world: the "clinical research associate" or "CRA". CRAs are are the CRO'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 "sites" (e.g. a doctor'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/writes documentation, and follows up as the trial goes on. In other words, the performance of the CRAs strongly & directly affects the performance of the clinical trial.
Anyway, my top issues with clinical trials today are:
(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 "trial rescue" is often done (at least where I worked) as a result of the incumbent CRO's inability to recruit enough patients.
(2) (Related) Limiting pay to study participants: although it's up to the institutional review board's interpretation (IRB, an ostensibly independent entity that's supposed to sign off on the trial's ethics), good clinical practice (GCP) guidelines states that paying participants too much would be "undue influence". I have no idea how this plays out in practice, but I think it'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.
(3) Clinical Research Associate (CRA) training & hiring: this isn't unique to the CRO industry but it seems like a bigger problem than in other industries. I'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'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 & 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't mean to say there aren'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'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, "Indian english" has taken on a life of its own).
(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 "change orders" and arguments over change orders.
Side-note: if you want to learn more about the process by which drugs come to market, I strongly recommend New Drugs by Lawrence T. Friedhoff. It's short and the HN crowd won't have any problem understanding. Amazon link: https://www.amazon.com/New-Drugs-Insiders-Scientists-Investo...
* "Unique" problems in the sense that they were personality-based. I won'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/her own family and dumpsters their own employees, you're going to have a bad time.
But first, I want to give some background on an important part of the CRO world: the "clinical research associate" or "CRA". CRAs are are the CRO'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 "sites" (e.g. a doctor'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/writes documentation, and follows up as the trial goes on. In other words, the performance of the CRAs strongly & directly affects the performance of the clinical trial.
Anyway, my top issues with clinical trials today are:
(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 "trial rescue" is often done (at least where I worked) as a result of the incumbent CRO's inability to recruit enough patients.
(2) (Related) Limiting pay to study participants: although it's up to the institutional review board's interpretation (IRB, an ostensibly independent entity that's supposed to sign off on the trial's ethics), good clinical practice (GCP) guidelines states that paying participants too much would be "undue influence". I have no idea how this plays out in practice, but I think it'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.
(3) Clinical Research Associate (CRA) training & hiring: this isn't unique to the CRO industry but it seems like a bigger problem than in other industries. I'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'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 & 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't mean to say there aren'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'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, "Indian english" has taken on a life of its own).
(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 "change orders" and arguments over change orders.
Side-note: if you want to learn more about the process by which drugs come to market, I strongly recommend New Drugs by Lawrence T. Friedhoff. It's short and the HN crowd won't have any problem understanding. Amazon link: https://www.amazon.com/New-Drugs-Insiders-Scientists-Investo...
* "Unique" problems in the sense that they were personality-based. I won'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/her own family and dumpsters their own employees, you're going to have a bad time.