Number of trials 1989–2007
Countries participating in gene therapy trials
The first therapeutic human gene therapy clinical trial was approved in 1990 and involved two children suffering from a form of severe combined immunodeficiency (SCID). At the moment about 90-100 new trials are registered a year. Gene therapy trials have been performed in 28 countries from all continents.
Number of trials 1989–2007
From 1990 until 1999, the number of trials initiated climbed rapidly. During this period, some voices expressed concern regarding the potential dangers of the procedure and critics pointed to the fact that gene therapy had proved of little therapeutic benefit thus far. In 1999 the number of trials peaked with 116 trials approved.
Following the serious adverse events in 1999 and 2002 the momentum slowed as several regulatory agencies put a temporary hold on new or ongoing trials. In 2003, only 81 new trials were approved worldwide, the lowest number since 1998.
Negative press coverage has undoubtedly dampened the enthusiasm for gene therapy and restriction from regulatory bodies while the adverse events were investigated will have slowed the growth in numbers of trials approved.
However, recent successes are encouraging, and the number of trials per year has increased in 2004 (95), 2005 (98) and 2006 (97).
Countries participating in gene therapy trials
Gene therapy clinical trials have been performed in 28 countries, with representatives from all five continents. The USA accounts for 64.2% of trials, Europe as a whole represents 26.6% of trials and Asia 2.7% of all trials.
Within Europe, the UK accounts for 11.1% of the world total with 150 trials, Germany 5.5% (74 trials), Switzerland 3.1% (42 trials), France 1.5% (20 trials) (an underestimate due to the paucity of information available), Belgium 1.4% (19 trials) and Italy 1.1% (15 trials).
Eastern Europe is starting to have an impact on the gene therapy community with six trials in Poland, one in the Czech Republic and one in Russia. It is known that there are more trials taking place in Russia but data are unavailable.
Seventeen trials have been reported from Australia, 16 from Japan and 54 from Canada.
Other countries where gene therapy trials have been performed are The Netherlands (13 trials), China (8), Israel (6), Spain, Norway and South Korea (4 trials each), Finland (3), Austria, Singapore, New Zealand, Denmark and Sweden (2 trials each), and one trial each in Egypt, Mexico and Taiwan. Twelve of the trials are reported as ‘multi-countries’ although a large proportion of the trials initiated in one country have centres in several other countries.
1. Michael L. Edelstein, Mohammad R. Abedi, Jo Wixon. Gene therapy clinical trials worldwide to 2007 - an update. Journal of Gene Medicine 2007;9(10): 833-842.
Eelco Soeteman
Last updated december 3, 2007
This information is developed by Egan by order of Consert.
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