Madrid, March 7, 2017 – Early clinical trials, which require a greater degree of complexity in research and allow patients to access new therapies early, have registered a sustained growth in Spain in the last decade thanks to the high scientific level of the professionals in the Spanish National Health System and the pharmaceutical industry’s commitment to R&D established in the country, among other factors. In particular, clinical trials in the early stages now account for 51.4% of the total, compared to 47.5% for the period 2010-2014 and 41.5% for 2004-2009, according to the latest data from the BEST Project for Excellence in Clinical Research, presented today in Madrid at the 10th Annual Conference of Technological Platforms of Biomedical Research: Innovative Medicines, Nanomedicine, Medical Technology and Biotechnology Markets.
This data reflects the consolidation of the increase in clinical research in the early stages, a trend that has seen an important boost with the new Royal Decree of Clinical Trials that came into force in 2016, which has created a much more favourable environment for the R&D of new medicines. In fact, according to data presented at the Conference by Javier Urzay, Deputy Director General of FARMAINDUSTRIA and Co-President of the Spanish Technological Platform for Innovative Medicines, in the first year in which the Royal Decree has been in force, the period in which to start a clinical trial in Spain has been reduced by 15 %, up to 131 days. The trend is thus maintained for the first set of data, obtained at six months, reflecting a reduction of 19% in the period when starting a clinical trial.
“The new Royal Decree has strengthened the good conditions in our country to host clinical trials, such as having highly qualified health professionals, a National Health System that is among the best in the world for its quality and infrastructure and an industry committed to research, “explained Urzay at the press conference held after the opening of the conference, which was led by the Secretary of State for Research, Development and Innovation, Carmen Vela; FARMAINDUSTRIA’s Director General, Humberto Arnés; The Secretary General of FENIN, Margarita Alfonsel, and the President of ASEBIO, Jordi Martí.
Thanks to this favourable environment for research, Spain has become one of the best countries in Europe to develop clinical trials, being currently one of the European states with shorter deadlines to start research and development of new medicines (from when documentation is first presented until the first patient is called up). Oncology is a good example of these favourable conditions, since 37% of the clinical trials carried out in Spain, including those fostered at the initiative of the pharmaceutical industry and those promoted by public entities, are carried out in the field of oncology, compared with 24% of the average according to data from the European Register of Clinical Trials (EudraPharm) for 2015 recently published by FARMAINDUSTRIA.
Another aspect that influences the increase of clinical trials in the early stages is the increasing involvement of patients in the process: “We are faced with a change of model regarding the role that the patient plays, which is now much more active, with thanks largely to the efforts being made also by patient associations in matters of information and training, “Urzay added. In fact, the entities that form part of the BEST Project, currently made up of 45 laboratories, 58 hospitals and research centres, 13 autonomous communities and three independent research groups, maintain a permanent relationship with patient associations through talks, workshops, and so on.
The Farma-Biotech Cooperative Program is another of the driving forces behind research into new drugs, an open innovation initiative launched by FARMAINDUSTRIA that favours the collaboration of the pharmaceutical industry with emerging biotech companies (start-ups) and R&D. Since 2011, when this initiative was launched, the program has received and analyzed 466 proposals that have resulted in the presentation of 110 projects for the development of new drugs, biomarkers, vaccines, antibodies, gene therapy and drug delivery systems.
A sector committed to research
As pointed out by the leaders of the Platform, the commitment of the pharmaceutical industry with activity in Spain is another key, since, as was stated, pharmaceutical companies already invest more than €1 billion per year in R&D projects, of which nearly half (41 percent) is used for clinical trials and basic research in collaboration with research centres and hospitals throughout Spain. The industry also makes constant efforts to reduce the timeframes for clinical trials, to count on the collaboration of the centres and to improve patient recruitment rates.
According to data from the BEST Project, most of the clinical trial participations following the Royal Decree coming into force, came from centres located in Madrid (26.8%), Catalonia (25.9%), Andalusia (12.1%), Valencia (10.5%), Galicia (7.1%), Castilla y León (3.5%), Region of Murcia (2.1%) and Basque Country (2%). In the rest of the autonomous regions, the percentage is less than 2%. As for the Medicines Research Ethics Committees (CEIm) that evaluates the trials, 40.5% correspond to Madrid, 34.5% to Catalonia, 7% to Navarra, 6% to the Valencian Community, 5% to Andalusia, 4.5% to Galicia, 1.5% to Castilla y León, 1% to the Basque Country and 0.5% to Aragon.
In any case, those responsible for the Platform consider that these results will continue to improve in the future, especially as the BEST Project action plan for 2017 is implemented, which involves collaboration with the Spanish Society of Healthcare Executives (Sedisa), the Spanish Society of Clinical Pharmacology and patient associations, among other entities, for the best conditions for the R&D of new medicines.
In addition, in collaboration with the Medicine’s Association of the Pharmaceutical Industry (AMIFE) and the Spanish Network of Pediatric Clinical Trials (RECLIP), a Guide for Clinical Research Units in Pediatrics is being prepared and will be presented in the coming months. To date, information has been received from 27 centres in eight autonomous communities.
The use of the big data
On the other hand, the representatives of the Platform have emphasized that clinical research today has an important international facet. In this sense, they have detailed the Spanish participation in the initiative IMI Big Data for Better Outcomes (BD4BO), of which FARMAINDUSTRIA is part of together with pharmaceutical companies, patient associations and public institutions. This program seeks to harness the potential of large amounts of information generated in the health sector (Big Data) and to promote the evolution of health systems towards value-based models and results measurement.
The initiative is already being developed in four specific pathologies (Alzheimer’s, haematological tumours, multiple sclerosis and cardiovascular diseases), in which the research teams involved intend to use Big Data to integrate data that allow for the answering of the most pressing problems with these diseases, develop more effective treatments and facilitate decision-making.
In this context, Jesús Mª Hernández, a researcher and haematologist at the University Hospital of Salamanca, presented on Tuesday the main outline of the Harmony Project, the initiative in the field of haematological tumors included in the aforementioned BD4BO and to which FARMAINDUSTRIA provides support. In the context of Harmony, researchers will try to draw the European map of this type of tumors, which currently occupies fifth place in terms of frequency, and third place in mortality; to establish criteria to harmonize the measurement of test results at European level and to define biomarkers that make it possible for patients to have access to new, more effective and better tolerated drugs at an earlier stage.
In addition to these aspects, the participants of the Conference will address the present and future issues of maximum interest for the development of biomedical research in Spain, such as new biomaterials for use in the area of regenerative medicine, aid to entrepreneurship or challenges Research and marketing of innovative health technology and drugs against rare diseases, among other issues. The full program of the Conference is available with this link.