April 4, 2023
Herding Cats: Why Can’t Clinical Trial Collaboration Be Easier?
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Industry Expert & Former CRAGuest
Hello I am Maria Milas, I'm the site engagement senior manager for Europe here at Teckro, and before I joined Teckro, I used to be a CRA. And this could have been easily me – a CRA managing and monitoring seven different clinical trial protocols, with sites all around Spain at the same time. On a daily basis, it means that I was constantly traveling. Maybe four days out of five, I was hopping on a train or on a flight to travel anywhere around Spain for a monitoring visit.
It also means that my email inbox was full of hundreds of emails that I actually had to take an action. My phone was constantly ringing and I constantly had notifications of missed phone calls from my investigators also waiting for me to get back to them as soon as possible. But even with all this, nothing is more challenging and stressful for CRAs than the site initiation visit. Already looks terrifying, isn't it?
But why is that? Well, the SIV is a very limited period of maybe two, three, four hours of a first monitoring visit at the site, and in that first monitoring visit – as a CRA – you gather all the team, all the members at that site who at that site who will participate in your clinical study. And in that visit, you will review all the study documents. You will obtain signatures from everybody in that team.
You will certify that they have been trained. You will obtain GCPs, check the equipment, bring the equipment that has been provided by the sponsor, but also the equipment that the site has and is providing with the roles and responsibilities of everybody in the team and most importantly, check and review the protocol. Solve and answer and discuss any question or doubt that the site, the investigators, the study coordinators, anybody in the team might have so that everything is clear and everybody is prepared for the big day, which is the first patient in the study. Now, let's say that the SIV has been performed.
Everybody's trained. Everybody's prepared for this big day and the big day comes. It takes some time because unfortunately, sometimes patients are not as easy to find as we expect. But here we are.
Let's say that my principal investigator is seeing a patient who is actually a great fit for the study. Finally! But wait a second. While my PI is seeing this patient I was living in Barcelona at the time and I was traveling to Madrid to a monitoring visit of a different study at a different site.
And when I landed from my flight in Madrid, I had five missed phone calls and several emails from my investigators, with the subject "urgent." And I can tell you now what happened. Well, my PI was not expecting this patient to be a good candidate for the study, so he didn't have access to the paper copy of the protocol. He didn't have it at hand with him and then he thought, “Well, I'm going to try to talk to Maria, my CRA.
She should be able to provide me with the eligibility criteria.” But I was not available to respond to his phone call. So then the investigator thinks of the sponsor and the investigator sends emails to the medical monitors, but also, he didn't know that the medical monitors at the sponsor was sitting in a different time zone. So unfortunately, our patient had to be rescheduled to the following week, and this site missed the opportunity to enroll the first patient in the study.
And how can that be? We had the perfect patient and of course, the patient was consented and enrolled in the study a week later but we missed the opportunity of being the site to enroll the first patient in the study, all because the PI didn't have access to the protocol. And having access to the study documents to the most updated versions of the study documents has always been a challenge to me as a CRA, because in my email inbox, I would receive all sorts of documents, from protocol amendments, to investigator brochures to pharmacy manuals, informed consent forms, safety letters, notifications, clarifications notes, recruitment updates, cohorts being open, cohorts being closed and all these documents, all these emails with documents with emails that I had to immediately send to my investigators.
And I remember one of the trials that I was monitoring; a new update to the protocol and to the informed consent form came around Christmas of that year – it was around 18, 19 December. I received it in my email inbox, I shared it with the investigators, I obviously also printed it, So that I took it with me on the next monitoring visit. And of course, with full inboxes, my investigators, most of the sites did not respond to me with a confirmation of having received that email, but that's a deal, right? Us CRAs, you know that your investigators will prioritize the patient care and the patient treatment.
So I went on a monitoring visit to this specific site at the end of January, according to the monitoring visit plan. And when I went there, I realized that the site was not even aware that there has been update to the protocol and to the ICF. And not only they were not aware, but they didn't have the patient consented and on this new ICF. And that means that we had the major protocol deviation that we actually had to report.
And let me just stress a little bit more the importance and at the same time, the challenge of the communication in a clinical trial: whether it's a document update that needs to be communicated to the site or if it's questions, clarifications that come from the investigators and they seek their response from the CRAs or the medical monitors, there is a need of urgency of immediate response and immediate awareness. And because I was a CRA and my email inbox would constantly be full of hundreds of not only emails with new documents or updates that had to be communicated, but also from investigators seeking advice from the sponsor or the medical monitors on how to proceed, maybe how to act on an adverse event.
And as a CRA, I was the bridge between the site and the sponsor. It could be that the site wanted to confirm inclusion and exclusion criteria or the management of an adverse event. As I just said, well, that email came into my inbox waiting for me to read it, communicate it with the medical monitor, wait for the guidance from the medical monitor and then communicate it back to the investigator, which could actually take probably days. Days?!
Meanwhile, a patient is waiting to know if they could join a trial with a new treatment for their condition. Or maybe it was about a patient who was on a treatment that should have been discontinued days ago. And there has to be a better way, a more efficient way to communicate important information updates to allow and support informed decisions at the point of care.
One: for the safety and well-being of our patients and, two: for the efficiency of a clinical trial. And how do we, as Teckro, tackle these communication and compliance challenges? Well, Teckro is a clinical trial hub where the sponsors, CROs and sites collaborate by having access to the clinical study content and also communicate with each other while having access to real-time data of what is happening in the study. And how does that look like?
Well, the clinical study document, such as protocol investigator brochure, pharmacy manual, any other study document, they're digitalized and available on Teckro to be searched on the app or on the website view at the moment of need. That means that actually my principal investigator who was seeing a patient and had to confirm the eligibility criteria for the study... well, he could just have typed into the app "inclusion criteria" and confirm those inclusion/exclusion criteria at the point of care while the patient was still in his office. In terms of communication, all study-relevant notifications are sent through Teckro, and the users will be alerted with a pop up notification on their phone.
That means that instead of worrying about the unlimited inbox of unread emails, the Teckro users know that the relevant notifications are on Teckro and they will be made aware whenever there is a new relevant notification available for them on Teckro. But what about the doubts and questions that the investigators might have during the course of a study? Well, the investigators can connect directly with a group of experts that are preassigned to them by the study team on Teckro, and they simply have to type in their question. And a member of these groups of experts will respond directly to them and will provide that guidance a communication that is visible to all the participants in the group and also can be exported and included in the eTMF.
On the Teckro app, the study team also has visibility into real-time data of all the searches that are being performed by the study worldwide. And it allows them to identify trends or behavior patterns. Imagine that several sites are searching for the same adverse event right after the baseline visit of their patient when the study drug is being introduced to the medical monitor or the study manager, this might ring a bell, and the study team could actually support these sites by maybe, as we can see on the right screen, sending them a quick survey and asking directly for feedback. What do they need?
How can they be supported? Do they need more clarification? Let's say that one of those sites is taking longer to recruit the patients than expected. Well, the study team can actually send them a quick survey and ask, "why is that?"
Do they need more support? Do they need more guidance? Or maybe it's just going to take longer than we expected, and we want to know the reasons why. So solving the communication, collaboration challenges in a clinical trial is vital to all of us, and that is why I encourage you to stay connected to us and maybe by our collaboration, we can also help sites to collaborate and communicate more efficiently as well.
And you can connect, whether directly with me on LinkedIn or follow Teckro on any of our social media. And if you're more interested in discussions related to the clinical trial industry, do not miss our Totally Clinical podcast. Thank you.
Industry expert and former CRA Maria Milas presents a simplified, centralized approach to clinical trial content and communication management to help everyone stay on the same page.
The initial phase of a clinical trial relies on a constant flow of communication and documentation exchange. Yet, the tools used today haven’t changed in decades. From a flurry of emails with different instructions to documents passing back and forth either as PDFs or paper, it’s a challenge for site personnel to keep everything straight.
This session was originally presented at the Feasibility, Site Selection and Study Activation Track at SCOPE Europe.