The BEST Project: fostering Clinical Trials in Spain

Transcription

1 MEDICAMENTOS INNOVADORES Plataforma Tecnológica Española The BEST Project: fostering Clinical Trials in Spain Amelia Martín Uranga FARMAINDUSTRIA Clinical Trials Session Seville, September 26th 2018 Spanish Innovative Medicines Platform is financially supported by the Ministry of Science, Innovation and Universities through the State Research Agency

2 Spain as an opportunity in pharmaceutical R&D National Health System with universal coverage and a good network of hospitals with excellent healthcare professionals. Excellent science and vibrant network of biomedical research (Academia, R&D Public Centers and start up co.). Strong and dynamic industrial tissue, leader in R&D (more than1 Bn per year, 20% of Spanish industrial research). Patient as active member in Biomedicine research. CT Session_BioSpain_Seville, September

3 Pharmaceutical R&D survey 2017 Breakdown of the R&D expenditure by research stages (2017) Almost a 60% of millions of intended for R&D in 2017 were invested in clinical trials (662 millions of ), investing 131 million of more in basic research. Data in thousands of Preclinical research Pharmacoeconomics, epidemiology, post authorization research Basic research Others Galenic research Clinical research Technological development Source: FARMAINDUSTRIA CT Session_BioSpain_Seville, September

4 Pharmaceutical R&D survey 2017 R&D expenditure by location: intramural/extramural expenditure Pharmaceutical industry pulling effect Although R&D expenditure within pharmaceutical companies research centres is higher (intramural R&D expenditure), a 47% of the total R&D expenditure was intended for research contracts with hospitals, universities and public centres (extramural R&D expenditure) 47% 53% Intramural R&D expenditure Extramural R&D expenditure Source: FARMAINDUSTRIA CT Session_BioSpain_Seville, September

5 BEST Project: excellence in clinical research Public-Private Platform for clinical research, lead by FARMAINDUSTRIA: it aims to monitor clinical trial processes, measuring its efficiency and competitiveness in the field. Background: started in January 2006 to tackle the risk of losing clinical research following Royal Decree 223/2004. Perceived loss of competitiveness and need to measure this situation. Aim: to make Spain an attractive country for clinical research Nowadays BEST is integrated by:45 companies, 55 sites, 13 regions & 5 Independent Clinical research BEST project CT Session_BioSpain_Seville, September

6 BEST Project: excellence in clinical research Successful outcomes % CAGR * Number of clinical trials in BDMetrics n.a n.a Number of industry trials authorised by AEMPS % 3% Industry expenditure in clinical rearch (M ) % 6% Industry expenditure in R&D (M ) % 4% Global start time of a clinical trial (days). 1st patient-in % -3% Differential with first European patient (days) % -12% Authorisation after EC opinion (days) % -13% Processing of agreement, contract (days) % -4% 4 Efficiency of recruitment (recruited/planned%) 92% 2 102% 11% 1% 5 Trials in early phases (I y II in % over total) 37% 48% 30% 2% 6 Trials in Oncology (% over total) 28% 51% 82% 5% *CAGR: Compound Average Growth Rate 1 Data Data Finalized CT in the year. The % varies significantly by therapeutic area and region. Percentage of non-recruiting sites: 9% 3 Data Sources: AEMPS &Farmaindustria CT Session_BioSpain_Seville, September

7 BEST Project: Description of projects After 12 years we have made important progress: Stakeholder engagement: hospitals, investigators, scientific associations, clinical research groups, patients, autonomous communities, the Spanish Agency for Medicinal Products and Medical Devices (AEMPS), ethics committees. Cultural change: clinical research is good for all stakeholders. We share aims and metrics with everyone. Competitiveness: metrics have helped us strengthen our competitiveness in Spain (timelines and recruitment). They enable companies and healthcare centres to benchmark with the group as a whole in order to pinpoint where improvements can be made Smoother dialogue between strategic agents (industry, healthcare centres, regions). Greater proximity helps to resolve issues (contracts, ICT, etc.). Exploiting this information allows us to know the progress in certain key indicators: start-up timing of the CT, recruitment, priority therapeutic areas. BEST identifies different practices and bottlenecks, helps to find solutions and keeps a constant communication among different stakeholders: AEMPS, Ethics Committees, Regions, hospital managers, investigators, patients. CT Session_BioSpain_Seville, September

8 Legal Framework in Clinical Trials Simplifying procedures Bureaucracy reduction Higher transparency Higher patient involvement (ECs) 1 Royal Decree 1090/2015, of 4 December, regulating clinical trials with medicinal products, Ethics Committees for Investigation with medicinal products and the Spanish Clinical Studies Registry 1 st country adapted to the EU Regulation 536/ 2014 Implemented since January 2016 CT Session_BioSpain_Seville, September

9 Active collaboration between the Spanish Agency and the Ethical Committees Since 2016, monthly meetings of the Spanish Agency - ECs (9 versions) Live documents being continuously revised in order to respond to changes A new work routine trying to reach a consensus in several documents that seek for legal security CT Session_BioSpain_Seville, September

10 Nowadays Spain as an opportunity in Clinical Trials One of the most important economic journals in Spain states the following on its headlines: Pharmaceutical industry positions Spain as a global power in clinical trials Farmaindustria active role s Meetings with representatives of Clinical Research from other Pharmaceutical companies Meetings with representatives of the Spanish Agency, Research Directors at Regional Authorities, Researchers, Ethics Committees, DPA (new GDPR) Meetings with Patients Association Meetings with Hospital Directors CT Session_BioSpain_Seville, September Academia ECs Sponsors PATIENTS HCP Hospitals Regions AEMPS ECs

11 Spain reduces a 20% clinical trial start-ups in two years time. MEDICAMENTOS INNOVADORES Plataforma Tecnológica Española 160 Spanish National Health System s high quality, health service provisions and infrastructure, highly qualified health care professionals, pharmaceutical industry s commitment with R&D and a favourable legal framework have situated Spain as one of the best countries to do clinical research in Europe. Timing indicators by Royal Decree in period (positive evolution) Global Tiempo start time Puesta of a CT en (days) marcha EC Contract Contrato (days) 1 st Primer patient (days) Paciente (RD2004) 2016 (RD2015) 2017 (RD2015) (RD2004) 2016 (RD2015) 2017 (RD2015) (RD2004) 2016 (RD2015) 2017 (RD2015)

12 Recruitment Speed Indicators by Royal Decree in period Working to achieve a better recruitment rate. Patients key role!!! Each year recruitment rate measured as the average rates by trial The % varies significantly by therapeutic area and region. Percentage of non-recruiting sites: 9% 24th publication of BDMetrics May % 120% 100% 80% 60% 40% 20% 0% Tasa de Reclutamiento 71,7% 2015 (RD2004) 124,6% 2016 (RD2015) CT completed by year of end of recruitment 94,2% 2017 (RD2015) There is a noticeable positive evolution in clinical trials under RD2015. There have been more trials completed in 2017 than in the previous years, probably due to the change in legislation. 12

13 Clinical trials in the early stages are growing steadily in Spain and already make up 51% of the total Evolution of Early Stages of Clinical Research MEDICAMENTOS INNOVADORES Plataforma Tecnológica Española Evolution of clinical trials, patients expected and patients inclusion in early stages in the following periods of time: , and ,1% 21,7% 24,0% Porcentaje de pacientes previstos en fases tempranas Percentage of the total of each group in each period 27,1% 30,3% 34,0% Porcentaje de participaciones en fases tempranas Porcentaje de EECC en fases tempranas 41,3% 47,2% 50,5%

14 BEST: International Benchmarking in oncology Initiation Phase Time difference for this phase (median country value subtracting Spain s median value) Spain, above the European average in clinical trials in oncology CT Session_BioSpain_Seville, September

15 Paediatric Clinical Research New tools to increase Paediatric Clinical Research The Directory of Paediatric Clinical Research Units in Spain was made in collaboration with 30 Units within BEST Project s framework Launched in September 2017 INTRODUCTION GENERAL OVERVIEW UNITS RECLIP (Spanish Paediatric Clinical Trials Network). Constituted in June 2017 CT Session_BioSpain_Seville, September

16 Best Project and patient associations in CT Change of model Patient centricity. Patient as active member in biomedicine research. Process of drug development What is a CT, who approves CTs, the role of the AEMPS, Ethical Committees, which law applies. How and when to participate in a CT Meetings in 2015, 2016, 2017, 2018 Diabetes Rheumatology/arthritis Oncology Rare diseases Anticoagulated Multiple sclerosis (MS) ELA-ALS CT Session_BioSpain_Seville, September

17 BEST Project: Next Steps What are we doing in order to be ready for the new EU Regulation? Guidelines for Site-Excellence (KPI performances, recruitments and metrics; human resources such as study coordinators/data entry; PI oversight; GCP; econsent; Investigator platform; RWD; Networking...) Updated of 3rd edition-directory of Early Stages Clinical research Units in Spain. In relation with new design in CT (basket & umbrella trials). Detailed information of 37 Early Stages Units High specialisation in oncology. Only 4 of them are not focused in oncology patients. Available in English & Spanish in CT Session_BioSpain_Seville, September

18 BEST Project: excellence in clinical research Conclusions: the importance of clinical research Clinical research is key for the pharmaceutical industry Excellence in clinical research is essential in a country's development: Industrial competitiveness. Advantages for the national health service: access of patients to innovative drugs; motivation, know-how and development of its HCP; prestige and image for its institutions; last but not least, financial resources and savings in medication. We are succeeding in making Spain an attractive country for clinical research. This has been increased in the last 2 years with the new legal framework. WORKING TOGETHER!!! CT Session_BioSpain_Seville, September

19 Thank you The BEST Project: fostering Clinical Trials in Spain Amelia Martín Uranga BioSpain Seville, September 2018