Investigating recent developments in clinical trials in Belgium: analysis of the data available at the Federal Agency for Medicines and Health Products (FAGG/AFMPS). Agenda. Belgium has a long and important tradition in clinical trials.
Investigating recent developments in clinical trials in Belgium: analysis of the data available at the Federal Agency for Medicines and Health Products (FAGG/AFMPS)
The Belgian pharmaceutical sector has a leading role in the achievement of the R&D investment targets which the EU member states set themselves as part of the Lisbon Strategy.
E.g. a trial for a standard drug in the US can cost up to $150 million. A similar drug could be tested in India for less than half of that amount.
Availability of large patient populations
E.g. India: genetically diverse, drug-naive population of over a billion people
Reformation of rules & legislations
E.g. India: reformation of regulatory approval in 2006 India will automatically accept certain protocols if approved in the recognized countries
Future conditions for clinical research in Europe
Objective of project
Organization of project
Figure1: Number of submitted and accepted trials at the FAGG/AFMPS
*No data availablefor Sem. 2 2009 at moment of analysis
Figure 2: Total number of amendments and distribution to ethics committees (EC) or FAGG/AFMPS
Figure 4: Percentage of trials per research phase
*Others= trials coded erroneously in the database
Figure 5: Percentage of industry sponsored and academic trials per semester
Figure 6: Percentage of industry sponsored and academic trials per phase (2006 to Sem. 1 2009)
Figure 7: Total percentage of trials per phase for top 5 companies (2006 to Sem.1 2009)
Figure 8: Total percentage of trials per phase for top 5 academic institutions (2006 to Sem.1 2009)
*EORTC= European Organization for Research and Treatment of Cancer
Figure 9: Percentage of newly started clinical trials per indication (2006 to Sem. 1 2009)
Genito and urinary system
*Phase I research (all therapeutic domains) is reported separately due to the specificity and importance
Figure 10: Percentage of initiated clinical trials per age group
Figure 11: Average number (N) of patients to be recruited per trial type and share (%) of global to be recruited patients
Figure 12: Average number (N) of sites to be recruited per trial type and share (%) of single site trials
Figure 13: Top 5 ethics committees based on the percentage of submitted applications.