Full disclosure: My background is not in clinical trials. Sure, I’ve worked primarily on pharma-related content for the past 14 years, but I never specialized in one component or stage of the drug development continuum. So, as I’m wading into this new position as Chief Editor of Clinical Leader, I’m always appreciative of people like Tiffany Ashton, MAS, CCRA who take the time to school me on some of the ins and outs of the industry. In this case, Ashton, who is director of operations at ClinEssentials, shared some of her insights from working for 20+ years as a CRC, CRA, clinical trial manager, and project manager. “I started as a CRC and worked all the way up the ranks,” she begins. “So, I know what it’s like to be the one saying, ‘Hey, what is this and how does it relate to all this other stuff?’ I kind of pride myself on being able to quickly give an overview [of a clinical trial-related topic] so someone can really grasp what we in the industry are talking about — because otherwise, you'll get lost in the weeds.”
The following excerpts showcase Ashton’s expertise (and patience) in successfully navigating me through my newbie-like questions related to the roles of CRCs, CRAs, and CTMs. What I came away with was a newfound respect for the people who endeavor to make these acronyms their careers — and a better understanding of why there is such a talent shortage in this industry today.
(The following have been edited for clarity)
How beneficial is it for a CTM to have been a CRA? Does it matter? I mean, obviously you could become a CTA and then transition to being a CTM without ever experiencing that road warrior life of a CRA.
It is in a sense [good to be a CRA before being a CTM], but it's not mandatory. So for instance, it makes you more well-rounded and empathetic to the CRA. It helps you know what the CRAs face when they're out there on the road and the challenges they encounter. So, when you’re wondering if they have the time to do all the things that you’re asking, you realize they may not since they’re running through an airport because of a gate change, or stressed because their bag didn't make it. Or, they’re driving through new cities and they’ve got bad weather to navigate, and then when they get on site, they have eight hours to do the laundry list of things they know they should do. Plus, there are always things that come up that are unexpected.
So, having a CRA background helps make you, as a CTM, more empathetic and may even help you reconsider unrealistic demands you may want to throw their way given everything they deal with on the road.
You previously mentioned CRAs traveling 10 days a month. Is that typical, and does that mean 10 sites in a month?
On average, there are 20 working days in a month. Typically, companies want CRAs to be on site eight to 10 days of those 20 working days. That does not include travel to and from their assigned sites too. Monitoring cycles are usually every four to six weeks. That means you're rotating amongst all of your assigned sites every four to six weeks. You would not likely see 10 different sites in one month as some high enrollers may require more than one day on site. Let’s say I’m going to hit all my Utah sites the first week of the month. Technically, I don't need to go to see all those sites again until the next month which is in alignment with my monitoring interval of visiting a site every four to six weeks. So a practical CRA will group their visits rather than flying between states in one week to be most productive.
Explain to me the different levels of a CRA.
It usually goes CRA I, CRA II, and then Senior CRA. A Senior CRA is usually someone who has four years experience of being a CRA, and that’s the level of CRA most companies typically want. They will accept CRA IIs, which have two to three years of experience. They are usually apprehensive about bringing in a CRA I to a team unless it’s a very easy study, like a Phase 4. After all, there's a learning curve to the CRA role, and depending upon their prior experience, a CRA I may not have been involved with start-up, maintenance, or close out in their previous role. So, if they get into an area that is foreign to them and they don't know what to do, they could make a lot of mistakes. There are a lot of trickle-down effects when a CRA is not strong, especially on complex studies. Phase 4 studies are the best type for new CRAs.
Dan Schell: You have your master’s in clinical research from University of California, San Diego (UCSD). Are there university-based programs for becoming a CRA?
There's not a master's in clinical research associate (CRA). There is a master's in clinical research or clinical research administration, but not in the CRA role specifically. That's why our industry needs training programs that will teach them what they need to know. For any role — CRC, CRA, CTA, CTM — you're usually just thrown in. Don't go into one of these careers expecting any formal training unless you join a bridge program, which is when the sponsor or CRO will train you for maybe three months, and you shadow for three months. Other than that, assume you're just going to get SOPs, some systems training, education on the protocol and how to complete your time sheets — and then they're going to put you to work.
Dan Schell: You recently traveled all over the world and interviewed various clinical research professionals. One of the things that struck me was that you said even in other countries, so many sites are still using paper for many of their trials. Why do you think this is the case? Why hasn’t there been more tech adoption throughout the industry?
I think our industry is very slow to change — for whatever reason. We're fast with advancing medicine, but we're slow to change processes. For example, when I first started 20 years ago, they said we would be all electronic in clinical trials within 10 years (so by 2013). All electronic medical records, source, everything. Twenty years later, we still do about 80% on paper. So, even though it makes sense, a lot of things are moving so fast, especially at sites, that the industry can't spend the time to put a new process in place or adapt to something new. You have to just keep rolling with it, even if it's less efficient. You don’t have the time to spare to learn a whole new system or way of doing things.
Sure, I get it. It’s not like there’s a shortage of technology vendors offering new solutions for almost every stage or aspect of a trial. But weeding through all those choices, much less being aware of all the options, would be a big job! And then there’s the whole single-sign-on conundrum that everyone talks about that further complicates things.
Consider that study coordinators are usually working on at least five studies, on average. If every study has five different vendors, that's 25 different vendors across the studies that they have. One of the biggest challenges is remembering the URLs and the associated passwords for each system and study!
There are some technology companies that are trying to merge with other technology companies to create one single login that then gives you access to, say, 15 different companies’ products under one login. The problem is, every study is different so if one or two studies are using single sign on for multiple vendors, chances are, the other three studies have the study coordinators working directly with multiple vendors. Study coordinators have to go with the flow on what is provided by the study team in order to keep their studies moving.