Clinical Trials Arena: What are the biggest operational challenges you face working in the clinical trials space, from a small company perspective?
Industry Expert: On the one hand, I think it’s dealing with the CROs and the lack of proactive activity versus reactive activity from the CROs. Additionally, dealing with CROs and ensuring your project team stays intact and that you have strong project management from the CRO’s side. One of the ways you can ensure that is writing it into your contract right of refusal for a project leader whether they be good or bad. Make sure that it’s written into the contract upfront that the key members are contingent upon and make or break a contract, so that if you lose your project lead you would get some sort of return and not be charged for new training, etc.
And also the operational people, you want to make sure you have a balanced, experienced monitoring team (if you have a lot of sites). But you don’t them to be so senior that they are looking to move on, so that at the first opportunity they will either be out the door or be tapped to head up another project internally. So don’t take everyone that’s handed to you; really scrutinise and examine each resume and interview people as though you were interviewing them for a job because they are.
CTA: What are some of the concerns (and reservations) you have about working with CROs?
IE: What I’m starting to see more often is the lack of experience among CRAs (Clinical Research Associates), clinical trial managers all the way up to the directors. Also there is a lack of involvement – there seems to be no ownership of the programme they’ve taken on that the sponsor pays them for. It’s really sad to see that all seems to be about money and not the programme and the patients themselves. We need the staff to focus on that and they don’t. They’re just not capable of doing the job we’re paying them to do. And this has been the case, I would say, in the last five to seven years. I’ve seen a generational change, as well as a change in staff and in attitude and commitment by that staff.
CTA: Has the apparent lack of work ethic had an impact on the quality of the trials you run?
IE: Absolutely – there’s been a drop-off and that has required much more oversight by us the sponsor to actually do the work and get out there with the sites. Also, we’re forced to spot check the data on an ongoing basis because of the lack of confidence that we’ve had within the CRO that is managing the study.
CTA: What have you done counter these problems. When it comes to seeking new CROs, how have you vetted them to ensure they meet your needs?
IE: Really emphasise the number of years’ experience that we require from the staff on the CRO side. Unfortunately, because of the high turnover rate you see in a CRO, you get a really good, experienced CRA replaced by one/two-year CRA and an indication that they have little experience. You can initially guard for that, but the changeover is ridiculous.
We’re working with a niche CRO that employs experienced CRAs. Considering the high level of turnovers, having that sort of continuity in a CRO is extremely important and incredibly rare to find. It safeguards the integrity of your clinical trial. It’s more work on the sponsor’s side; there are more vendors to manage, but ultimately, the quality of the data – which is key in clinical trials – is where it should be.
CTA: What are the best ways to incentivise or encourage CRO team members?
IE: There are many things one can do to incentivise CROs, such as putting bonuses into the contract as rewards. Such a scheme can help monitors become more engaged with the study. What’s more, sometimes limiting the number of people involved in the study can be helpful as well. This keeps them busy and they’re not spread across several different sponsor projects you can isolate them onto your project and have them as dedicated as possible.
Lastly, including CRO staff in team meetings and letting them understand their value to the study is extremely important. Some sponsors may not want to do that because when a CRA sits in on a meeting they get a charge, so it’s a balancing act in terms of managing your resources and keeping CRAs engaged and letting them know their value.