Dear clinical trial experts and colleagues,
I would like to pause today to share with you some thoughts? Fears? Challenges? About this “world” we know, cherish, have been and are still building clinical trials.
Our planet of 510, 067 420 km2 (source: Wikipedia) was drastically impacted by a small agent 60-140nm in diameter (Source: News medical ). If the previous stated dimensions can be ironic, some other figures have been tragic.
COVID-19, what a name! Today even our grandmothers in remote areas who only speak local languages and have never gone to the city now not only perfectly know the “dude”, but have seen their life impacted one way or the other.
Clinical trial arena has not been spared. A CRA going for 4 days of monitoring visit would previously simply plan for his/her visit, confirm with the site, and may be add an average of 2 days for travel time.
Today, even with the best possible planning, he/she will not be sure to travel to his/her site in the first place. He/she will have to show a negative COVID test to fly out of his/her country. And in many cases a negative test also must be taken upon arrival in the site’s country. If that test is positive, the poor colleague will have to be quarantined for 10-14 days minimum in a foreign country, far from his/her family and loved ones. Let’s not talk about if he/she is no longer asymptomatic…
When your visit is over, with all the stress that this could have represented sometimes, the idea of going back home soon is priceless for a CRA. Again, today, it’s no longer a straightforward path. You need to successfully pass those “COVID tests examinations” (remind us about school, may be?!), with sometimes terrible impacts: flights cancellations, delays, extra hotel accommodation days, quarantine, etc.
If it was only logistic impacts that were involved… But this 60-140nm diameter agent is seriously impacting the actual conduct and even occurrence of trials globally: study staff detected positive, kick off of studies being delayed or cancelled, etc. Not to mention the scientific and financial impacts of these situations.
It’s no secret that the world we’ve known is changing. In the current concept of pandemic, we are all forced to re-think the way we work. If not already done. Some of us have decided to stay indoors completely, some have opted for going out with some “new rules”, some others have not changed much to their lifestyles…
Whatever the option we choose, technology and distance work are becoming more and more the norm. Technology has undoubtedly brought tremendous, good things to our lives over the years. In clinical trials like in many other domains, it has made our work in so many areas much more efficient and it still is. Distance work has also in many ways been of a great benefit. I will not be the one to complain about this, especially as a wife and mother.
I indeed appreciate in many ways this new e-work/world. But here is my question to myself, dear valuable reader -sharing it with you: in dealing with human beings safety and integrity of data, how much will we be able to achieve “remotely”, without physically being on site? How much are we ready to “overlook” in the process?
You, clinical trials experts – especially those with field experience – surely understand what I mean here.
I am conscious that we might naturally be reluctant to change, especially when that change is from a “secure zone” to an “unknown” one. But I am part of those who believe that we must always change the good for the better. The challenge is most of the time to identify what the “better” is.
We are probably – or should I say certainly? Future will tell – at an important crossroad of clinical trials conduct and management. May we be smart, wise, courageous and blessed enough to identify which direction to take. I have no doubt that we will make it!
I wish us all a successful choice!