Today we would like to take a closer look into the challenges the clinical site networks are facing in these hard times, how it affected active and upcoming trials and what we need to do to keep the trials running, limiting the delays. Are Virtual Trials becoming a new way of performing clinical trials?
We will be talking with Michaela Vančová, managing director from Slovak Research Center which is a site network based in Slovakia conducting Clinical Trials in various indications. So, we asked her for more details.
Right now, we are having 7 open clinical trials at 12 sites. Due to the situation with Covid-19, only 29% percent of the open clinical trials and sites are continuing recruitment, everything else was stopped. When it comes to the on-site visits, 50% were switched to the phone contact or other type of visits, the rest is running with necessary precautions as before. Other site activities like monitoring visits, initiation visits, pre-study visits were stopped. And just recently the pre-study visits and initiation visits were opened again. Monitoring visits should start in the following weeks.
Study visits like any other patient visits are conducted under all precautions and in compliance with all safety measures. Patients were contacted the day before the visit by phone, asked about the travel history, about being in contact with someone who traveled to affected areas, about being in contact with someone positive for COVID 19. If both negative, patients were asked to come to the site. At the door, the temperature was measured as the first step and after that patient could enter the site, was given the sanitizer for hands and the actual visit started.
If the patient was afraid to come to the site, we followed the RA instructions, and the study drug was picked up by a family members.
From our experience, I have to say that 95% of patients came for scheduled visits. The other 5% were patients who were having serious concomitant diseases and it would be a risk for them to come.
Our patients were very disciplined and so far, we have not any reported COVID cases in any trials.
Is there anyone who could say that the situation did not surprise them? 🙂 administratively yes-we did not have pandemic SOP in place, but we do now. To summarize it now, there is nothing except SOP you can really prepare-as a site, all other decisions were taken by sponsors-they decided which studies stop recruitment, which is running, which are continuing with site visits, which are doing phone visits instead. So, from the site point, I guess we wouldn’t do anything another way even there is another pandemic coming.
We have participated at many webinars and discussions, but in practice nothing yet-again, in ongoing clinical trials we are not allowed to change or implement anything-we would need sponsor approval for that. Sites are now in strange situations-we are end-users, trials are designed by sponsors and CROs, so we do not have an influence on that.
We passed our training for virtual trials even before pandemic started and we are very ready. But again, unfortunately, we are not decision makers-we need to wait what sponsors come with.
The site can train themselves- there is a virtual trial certification training available for free on the SCRS website for everyone.
As I’ve said, yes, we were preparing for that even before. It has advantages and sooner or later, virtual trials will come also to our part of the world. I don’t know if it would mean reduced costs for sponsors, but I’m sure it would be more comfortable for patients, especially it would be appreciated by younger patients who are still working-not to take days off for coming to the onsite visit.
That’s a hard question 😊 we have not received any feasibility for hybrid/virtual trial yet. Many sites are presenting themselves already for COVID trials. We are not going this way. Slovakia, fortunately, has very low numbers of COVID positive patients, so it does not make us attractive for this kind of trial. We prefer to concentrate on the trials with delay. It was presented many times that more than 60% of ongoing clinical trials are delayed due to the current situation. We would like to offer our services to these sponsors and be one of the rescue sites/rescue countries, we are ready for that.
I think mentality. Eastern European region simply likes everything the old-fashioned way and it always takes time to become open for new things coming. Hopefully, the situation with pandemic will make this process faster and we can also be part of the trials that use the newest technologies.
Hard to say I think the regulations are okay, it is just the fear of unknown. It just needs the courage to give it a chance and try.
There were not many revolutionary changes for us. We are definitely keeping our newly created SOP for pandemic and we hope that all people in the world will keep washing hands more often than they used to.
Never say anything can surprise you.