IN PARTNERSHIP
and increasing the number of clinical trials. Nevertheless, Spain is currently considered a benchmark in terms of the two most important variables in research: quality and development time and investment in setting up innovative clinical trials, together with the USA.
What other challenges are they facing?
OS: Spain faces competition from other countries that continue to improve in terms of efficiency, investment, resources and competitiveness in terms of all the ratios that are assessed in a clinical trial, as indicated above, basically the time taken to carry out the trial from its start-up to the results report, as well as the quality of the data. On the other hand, a very important
challenge in order not to lose competitiveness against the USA and APAC is the implementation, as well as the early availability of European regulations on the use of new technologies applied to clinical trials and the management with the data protection law. The agility in the implementation of these regulations and their applicability could cause us to lose competitiveness in Europe compared to other regions that are more agile in their implementation.
How could we bring the topic of clinical trials more to society?
OS: I believe that, fortunately or unfortunately, since the pandemic, there is greater awareness among the general population of the steps that must be followed to be treated with a drug and that the scientific tool validated today to obtain authorisation for marketing and use is the clinical trial. Disseminating results as well as their applicability to the population should make us think that participating in a clinical trial goes beyond our best treatment but also benefits the rest of society, and never forget that someday we will all be patients and that to a greater or lesser extent both the quality of life and life expectancy in the last 50 years have improved greatly thanks to research and the conduct of clinical trials, following scientific methodology there is no other way to improve in safer and more effective treatments.
OS: Artificial intelligence is safe and we should not fear its use. We are waiting for a greater implementation in the sector, basically due to the development of laws, especially due to the great difference with other sectors such as the protection of patient data. From all the actors involved in clinical trials: sponsors, CROs, centres... we already have a lot of advanced work with artificial intelligence, which will help us improve efficiency and avoid errors. Artificial intelligence is one more tool that will help us to improve development time and quality, just as many years ago the use of the calculator improved errors in basic arithmetic operations.
Some time ago he commented on how difficult patient recruitment can be. As an opportunity, AI algorithms can analyze large data sets to identify the right patients to participate in clinical trials, which improves the science and accuracy of selection. As a disadvantage, the application of current data protection legislation or the fear/security of data hosts to use and share data. Anything to add? Is public-private collaboration key?
OS: It is key, as in all sectors. In the health sector it already exists and is working. Moreover, clinical trials involve public and private centers in the same projects and with the same objectives. With regard to public- private collaboration, we are also improving in promoting new trials, although we still have a long way to go. Basically, we need the public sector to consider as a priority real investment with resources in clinical trials that help to improve patients’ lives. We cannot be happy to be where we are, but
we must continue to invest, prioritise, invest, and innovate as a country to improve the quality of life of everyone and to have a healthier future for the entire population. The clinical trial is the only validated tool to achieve this.
Outsourcing in Clinical Trials Handbook | 23
It was noted at the AECIC conference that artificial intelligence is revolutionising clinical trials by optimising study design, improving patient selection, and speeding up data analysis, resulting in faster and more effective treatments, at the point where we are now is it completely safe?
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