Happy Clinical Trials Day

Today is clinical trials day. Honestly I didn’t know that such a day exists. I do not like this kind of purely business “events”. But looking at all the posts celebrating this day, I started to think and made some considerations I would like to share.

I’ve started to work in clinical research when I was 26. This year I celebrate 30 years in clinical research environment. A long walk for me. Probably it’s a Record Guinness.

I’ve worked in both Pharma and CROs, I’ve seen most of the aspects of clinical research. In some period I hated my job, in some other I loved it, but I’ve always been sure of the importance of a well done, ethical clinical research. That’s why I’ve never changed.

I’ve started to work in the years GCP where not a regulation yet, so I really saw any kind of things, I’ve seen all the changes and improvements and the challenges that any new cycle, any new Regulation was bringing and the hard work done, every time, to become compliant.

I’ve really seen several revolutions in this field. And this, it might seems strange, makes me proud. I’ve always been part of it, I had the chance to see all this.

Who directly knows me, knows that I’m an optimistic person. We had 2 terrible years with the pandemic. Our lives, and way of living completely changed. And also our working processes had to fast and quickly adapt to the new realty.

We can now start to take a long breath after COVID (we will see in autumn), and I think we have to look at the future focusing on the important positive lessons we have learnt over the past 2 years.

It’s another revolution overall, and in particular for clinical research we have all learnt what an impressive result can be obtained using the tools and processes to manage Decentralized Clinical Trials. This approach was just at the very beginning 3 years ago, and now all of us need to recognize its importance.

I’m not going to talk about the tools, the technologies, the new processes and what this implies for pharma Companies and CROs.

I want to focus on the great results for patients. Our work directly involve patients. This is a huge responsibility and what make clinical research an highly ethical work. Many times a clinical trial is the only way for a patients to have access to innovative treatments, and have an immediate effect on their lives. This is great. Decentralization has increased the number of patients that even if living far for investigational sites, can now be included in the trial. It has decreased the number of journeys to the sites. It has increased the number of procedures that can be done at home, in the most comfortable place we want to be when we need to be cured. And you can imagine how important this could be, when you suffer from a disease that has no cure, or you are not responding to standard cures.

With Decentralization enrolment can be faster, especially for early phases trials and this shorten timings to go to the following phases and then go on the market with new innovative therapies. And this is at the end what we all are dreaming of.

With Decentralization diversity can be much easily managed. From the beginning you can include diverse populations and once again cut the final timings for registration.

This is patient centricity and this is great, this is what we are working for. This is the most ethical part of our work. And it's great.

COVID-19 put patients in clinical research at the centre probably for the first time really.

And this is great. These revolutions are what make me passionate, still after 30 years. The idea that our job can in some way support patients’ quality of life.

Happy Clinical Trials Day