Speaking from a general safety perspective, as well as a cardiac safety perspective, what challenges have you observed in clinical trials resulting from the COVID-19 pandemic? [3:07]
I speak for myself and others, no one trained us for this and we had to quickly react. We want to ensure the safety of the participant as well as making sure the data is right. We have to consider what is in the best interest of the patient and how we can ensure that the data that is collected will be able to be analyzed at the end of the study. We had to rethink what to do, but the situation differs. For a company in Phase I with very little information, it’s not the same as a Phase IV clinical study. However, the common ground is that they try their best to maintain the integrity of the trial. In particular with cardiac safety, there are certain parts of the clinical trial where remote monitoring can continue to be done.
What approaches have you seen employed in managing these challenges? [8:40]
What I see the most is that one size does not fit all. Certain studies you cannot stop. Overall, what we have been trying to do is hold a very careful assessment of the conditions of the patients under study and the risks vs. the benefits of stopping or continuing the study.
Thinking back, what do you think was the general consensus in the industry with respect to virtual clinic trials one year ago, versus today? Was this something under discussion? If so, how was it meant to be applied, versus what are you seeing now, and versus what we may see in the future? [12:00]
One year ago virtual trials was an interesting topic that needed to be further developed and was worth discussing. Now, it is something that we jumped into in order to ensure trial integrity and safety of the patient. What do you do when you’re in the middle of a study and you realize you cannot collect that data and if you want to complete the study, changes have to be made? If you were supposed to collect the data in a certain way at a certain location, now you have to modify what you had done before in order to ensure the safety of the patient and the accuracy of the data. Virtual studies was no longer an idea, but an urgent need that had to be implemented immediately.
As we adapt to the current paradigm, certain changes are occurring in the way we all operate. There’s a lot of talk now of a hybrid model in clinical trials as a means to continue studies during this pandemic. Of these changes, what do you see as temporary, versus a change reflective of the future of safety monitoring in clinical trials? [17:48]
During these times we are getting a crash course on things like digital collection of many different outcomes and safety monitoring that in the past we were underusing or didn’t know how to properly implement. This is pushing us to better define, monitor and focus on the essentials in clinical studies. If we can make it easier for patients to be a part of clinical studies, there might be a higher participation of people that want to volunteer. If we can take advantage of the tools that we currently have available and the others that are yet to be developed, there will be more real life data.
From the patient's perspective, do you have any thoughts as to how they might view clinical trial participation in context of the COVID-19 pandemic? [20:33]
If you can ensure patient safety and can communicate that the setting that’s been set up in a study is ensuring safety for them, that will make them feel reassured. We are making it easier for them to complete the different assessments. In order to do so, there has to be adequate training to ensure the safety of the patients and adequate data is collected.