In recent years, Spain has become a world leader in clinical trials, thanks to the strength of its healthcare system, the high qualifications of its healthcare professionals, a sensitive Administration that promoted pioneering legislation in this area, patient organisations that are increasingly involved, and a pharmaceutical industry committed to R&D in our country. Today, one out of every three clinical trials carried out in Europe with new drugs involves Spanish participation, and more than 60% of the investment in research made by companies in Spain goes to clinical trials.
Our country, in addition to being a benchmark in terms of volume, is also a benchmark in terms of quality. The search for excellence in clinical research is a maxim that biopharmaceutical companies based in Spain seek and promote. As a result of this relentless work, four key documents have been published in the last two years to further improve the conduct of clinical trials in Spanish centres.
The first two – in the form of guidelines – were created with the aim of achieving more and better involvement of patients in the research of new treatments, one for the adult population and the other, due to its special characteristics, for paediatric patients and their families. In this sense, both guides, promoted by Farmaindustria and the result of collaboration with different agents, are based on the premise that clinical research cannot remain on the sidelines of the evolution of the role of patients, who are increasingly more involved in the management of their health, and this also includes the research and development of medicines, a process that must better understand their needs in order to respond to them.
The third of the guidelines, presented last April, focuses on hospital pharmacy. Given that research into new medicines is becoming increasingly open and collaborative, and that new treatments – based on precision medicine – are becoming more complex and demanding, hospital pharmacists need to be more involved and collaborate more closely with the clinical trial team, given the added value they can bring to the process and to patients.
In addition to these documents – a reference in Spain and Europe – there is the Code of Conduct regulating the processing of personal data in the field of clinical trials and other clinical research and pharmacovigilance, which regulates how data protection regulations should be applied by sponsors of clinical trials with medicinal products and the Contract Research Organisations (CROs) that decide to join them.
These are all living working documents to which pharmaceutical companies are fully committed. Precisely so that their application is directly reflected in the excellence of clinical trials in our country, Farmaindustria has held two training workshops this week.
One of them was attended by two representatives of the Spanish Data Protection Agency (AEPD), Jesús Rubí and Julián Prieto, and analysed various practical issues of the new Code of Conduct, in relation to the EU Regulation 536/2014 on clinical trials on medicinal products for human use, as well as stressing the value of adhering to this regulation on a voluntary basis.
In this workshop, it was recalled that adherence to the Code of Conduct provides greater legal certainty to the processing of personal data carried out both in the field of research with medicines and clinical and biomedical research and in pharmacovigilance; facilitates compliance with data protection regulations; provides the incentives that the current regulations attribute to self-regulation systems (adherence to the Code alone may be used as an element to demonstrate compliance with the law), and can avoid the initiation of sanctioning procedures by the AEPD.
The second training session was attended by the heads of the Clinical Trials Department of the Spanish Agency for Medicines and Health Products (Aemps), Mª Antonia Serrano and Marta Godé, as well as the representatives of the Ethics Committees for Research on Medicines (CEIm) of the La Paz and La Princesa hospitals in Madrid, Emma Fernández and Mara Ortega, respectively.
Those attending this workshop were able to learn first-hand about the experiences following the implementation of the European Regulation on Clinical Trials (536/2014), from the point of view of the Aemps and the IRBs, but also from the perspective of some of the pharmaceutical companies that are more advanced in this application.