Clinical Trials Arena: As a clinical trial manager, what are some of the challenges you’ve throughout your career?
Diana Petraki: In my experience of working for smaller companies, one of the big issues I face when dealing with CROs is that they might not give you the same amount of attention as they would perhaps a bigger company. From a quality standpoint, I would say this has been a recurring issue throughout my career. Regardless of whether it’s a big CRO or a smaller CRO, the quality of service, as far as meeting deliverables are concerned, is not always there.
CTA: How do you deal with that from the Sponsor side? How do you ensure the CRO meets your needs?
DP: It comes down to oversight. You have to put in a lot of energy and keep a closer eye on operations; use your experience to give back your input. You will also have to try to get them in line with your company culture which is probably the case for all companies, big or small, when you’re beginning to work with a new CRO or team, there’s an adjustment period in the beginning where you get them in line with the way you do things. It’s a process – sometimes it works, and sometimes it doesn’t. There are times where the quality and the experience just aren’t there, and in those instances you have to ask someone else to step up to the plate, or escalate it within the company to try to get a new person assigned to the project if no other solution can be found.
CTA: Could you give an example?
DP: There was one particular case where there was a clear language barrier with the person the CRO had assigned to be the lead CRA. At one point we were forced into making a change because it was impossible for me to rewrite every sentence of minutes and reports. So things didn’t work out in that situation.
CTA: Do you think processes can be improved in terms of managing vendors?
DP: That’s the big question. In the project I’m currently working on for some time now, it’s been a case of so far so good. A lot depends on the CRO you’re working with; I have colleagues working on newer projects with bigger CROs and the problems still seem to be there.
CTA: What are some of the other challenges that you face?
DP: Meeting your timelines is a problem that won’t go away, in terms of achieving milestones (first patient in, last patient out). You might meet your first patient in, but there are always unforeseen causes for delays, such as your IRB approvals. While you anticipated that would take you four weeks, based on the dates, you could receive comments that would set the whole process back. And once you’re up and running with your first patient in, you could encounter even more issues, but that’s the nature of the beast.
CTA: Is patient retention is an aspectthat is difficult in your disease area?
DP: For patients with a rare disease, sometimes they have no other option so that in itself is an incentive. Otherwise, what can drive patients away is because some are coming from far away (the trial I’m working on is a phase one trial with one site in the US), so they are coming from all over the country, which can be demanding for them. In that instance, this is something a patient can usually assess during their first travels to the site and can decide they don’t want to participate. In other cases, the patient realises during the course of the study that they’re exhausted from the travel and withdraw from the study, that’s something you don’t have much control over.
CTA: I gather that’s the thing with rare disease CTs where you have a pool of patients that are eager to be involved because for some it might be their last option
DP: Absolutely. For some, it’s their only option, but yes, recruitment is probably the biggest challenge. When you do your feasibility with the sites – the sites often overestimate the number of patients in their database that meet the criteria to enter a trial. This is a recurring issue in clinical trials and I think it’s just for us to adjust and figure out. To deal with the issues that come with patient recruitment it boils down to approaching and enlisting more sites as the numbers might not be as exact as you want them to be.
*Diana Petraki is a Clinical Trial Manager at a pharmaceutical company specializing in rare diseases