Our study evaluated the distribution of oncology clinical trials in Europe during the period 2009-2019. We used the clinicaltrials.gov database or platform to do this research and gather the data. We did an initial search for new patterns and all the interpretational studies in adults between 2009-2019 from early phase to phase III. From that we could map the results to 34 countries in the European region. Then we analysed that data.
What our study showed is that there are symmetries, and some of them quite large, in the distribution of oncology clinical trials in Europe. We have numbers that vary from 0.4 in Albania to 11 in Belgium per 100,000 so it’s a large difference. The analysis also showed that the western and northern regions of Europe have the highest number of trials while the eastern region has the lowest number, even if we are talking about trials per 100,000 inhabitants, as I mentioned before.
There is a large difference within the same region and, in general, we could see that countries with the highest number of trials are also the countries that have the highest number of early clinical trials, or the highest proportion of early phase trials. That reflects some kind of engagement in research.
We addressed the relation to the GDP and the cancer incidence but, despite some moderate correlation, that correlation cannot explain the observed symmetries. So this is suggesting that there are other factors at play.
Overall we could observe an increase in the number of trials in Europe between 2010 and 2018, more pronounced in the early phase, and that was a positive trend. But still some countries, and especially the countries with the lowest number of trials, had a contraction in the total number of trials during this period which is not positive, not at all. So those were the major findings and if you have to take one take-home message I would say that there are symmetries and those symmetries that we observed can lead to potential symmetries in the access to clinical trials in oncology.
What were the motivations for the study?
We think, because this was a study done by the LGP 2019 group, we have long had the impression in those that work within oncology that there is a symmetry in the clinical trials in Europe. So somehow we wanted to map those events or differences and see the data which we could do. So the most relevant data is the relations with the regions, the GDP, the cancer incidence to see if those factors could explain the symmetries. But we also know that we need to go further and look into each country and see, try to explain why some countries are doing so well while others are not doing so well despite maybe similar GDPs or cancer incidences.
To see that other countries are doing better or worse might lead to a reflection on why is it so and trying to learn and get better from that comparison.
What were the challenges to the study?
The challenges are mainly the statistical analysis and to do them well and to address the right questions in the right way. But I think we got good data and we’ll do further analysis.
We are doing more analysis and will continue to do. We are looking while breaking down the data to countries and regions. I think it’s extremely important in terms of public policy because clinical trials are very important in the cancer treatment and in the development of new cancer treatments and access to new treatments which may be made available for our cancer patients. So this is what we are doing because we believe it is important. It will come in the paper with all the analysis in a couple of months, I believe.
Are there comparable studies in other regions?
No, not that we are aware. There are some studies or reports done in the US looking at the symmetries with recruitment of patients and access to clinical trials as such based on social disparities. There are some reports done by the industry and also by authorities within each country but not a global study, that we haven’t seen before.
How have the findings so far been received?
Yes, we have received some comments and people want to know more details about disease distribution to be able to work with this information that we are bringing to light. Some also feel that for the first time we could put this into numbers and black and white without just having this kind of feeling that clinical trials are not evenly distributed in European countries.
I also think that some people working with clinical trials or agencies have looked into this as positive data to be able to compare yourself with others which is also important. You cannot only know how well you are doing, you need to know how well you are doing in relation to others to see how better it can be.