SCORR Marketing and Applied Clinical Trials EU Clinical Trials Survey Report 2015

Transcription

1 SCORR Marketing and Applied Clinical Trials EU Clinical Trials Survey Report 2015

2 Overview How regulations impact where clinical trials are held has been an ongoing question in the drug development services industry. SCORR Marketing, in partnership with Applied Clinical Trials, conducted a survey to gather industry opinions about the impact of the EU Clinical Trials Directive (2001/20/EC) on global clinical trials in the European Union. The directive, implemented in 2004, was intended to simplify and harmonize clinical trial regulations in Europe while also improving participant safety and data quality. A new regulation, EU-CTR (EU) 536/2014, has since been adopted, but will not be implemented until Global respondents included individuals from different types of companies including, in part, drug sponsors, s, academic institutions, consultancies and service providers. Those taking the survey had positions in research and development, clinical directors, regulatory, corporate management, QA/QC, business development, medical affairs, and strategy or planning. In this survey, we gathered information on: Impacts the directive has on drug development services organizations The effect directive makes on where clinical trials are conducted How beneficial the directive really has been Why some see Europe as a less attractive place to conduct clinical trials Which areas are seen as the most attractive places for clinical trials

3 Has the directive impacted your organization? 57% 26% UNSURE 17% Do you feel the directive has impacted where trials take place? 63%, How... d bureaucracy and red tape d costs Has the directive harmonized and simplified trial requirements across the EU? 52% 48% Is Europe a less attractive place for trials because of the directive? 37%, Then what impacts the location... GCP/Investigator experience Lengthy clinical trial approval times Reimbursement/ pricing issues Regulator y issues 41% 59%

4 Where Companies Want to Go for Their Trials 30% 61% 15% 38% 11% 50% 13% 11% North America Sponsors favor North America far more than s. 21% 32% 24% Russia/Eastern Europe 28% 46% 19% Latin America is more attractive to s than sponsors. Stagnation in trial applications in Europe since % Sponsors are twice as likely as s to see Russia/Eastern Europe as attractive. 24% Latin America 54% Other Asia (e.g., Japan, South Korea) More s than sponsors consider other parts of Asia as more attractive. Part of a global trend Regional phenomenon 35% Outlier 8% 56%

5 Have the benefits of the directive outweighed the costs? 51% Will the EU-CTR 536 do enough to address obstacles for research? 49% 51% Do you feel the EU-CTR 536 will improve the trial applications rate? 49% 54% 46% Where will the number of clinical trials increase or decrease? Drug Sponsor 50% 22% 32% 8% 37% 11% 16% 46% 40% 10% Australia India Drug Sponsor 22% Other Asia (e.g., Japan, South Korea) Latin America Russia/Eastern Europe China North America 24% 54% 33% 14% 21% 27% 27% Western Europe Drug Sponsor 39% 29% 77% Middle East/North Africa 22% 30% 43%

6 Three Main Points: The directive has made an impact, but perhaps not as much as intended. A majority (57%) of all respondents and 94% of drug sponsors say the EU Clinical Trial Directive (2001/20/EC) impacts their organization. A larger majority (63%) say it has impacted where trials take place. The directive s benefit is questionable. More than 10 years since the directive was initially implemented, only a slim majority believes: The directive simplified and harmonized clinical trial requirements across the EU (52%) Benefits of the directive outweigh the costs (51%) EU-CTR (EU) 536/2014 will go far enough to address obstacles to doing research in Europe (51%) (Less than half of drug sponsors and s believe it will.) The number of clinical trial applications in Europe will improve (54%) There is more support for the directive in some quarters than others. For example, almost two-thirds (65%) of respondents who work in research and development believe the directive simplified clinical trial requirements. About three-quarters (77%) of respondents who work at an academic institution and 75% who work in regulatory positions believe the clinical trial approval rate in Europe will improve. Respondents are looking at places other than Europe for their clinical trials. More than two in five respondents (41%) say Europe is a less attractive place to conduct clinical trials because of the directive. More attractive locations: North America and parts of Asia such as Japan or South Korea and Russia/Eastern Europe. In five years, clinical trials will move away from Europe and head to Asia and Latin America, respondents say. These countries will have more clinical trials: China (chosen by 46% of respondents) Other Asia (e.g., Japan or South Korea) (chosen by 40%) Latin America (chosen by 37%) These countries will have fewer clinical trials: Western Europe (chosen by 43% of respondents) The Middle East/North Africa (chosen by 30%) Russia/Eastern Europe (chosen by 27%) Other Key Takeaways The EU Clinical Trials Directive has impacted companies by increasing costs and affecting where trials take place. Other factors that impact where trials are conducted include clinical trial approval times and other regulatory issues. The directive has made Europe a less attractive place to conduct clinical trials because of study startup delays and inconsistency of interpretation across EU member states. North America, Asia and Russia/Eastern Europe are attractive locations now. In five years, trials will migrate to Asia and Latin America. Stagnation in the clinical trials applications in Europe is part of a global trend.