France is holding its own internationally as a location for later-phase clinical trials. Within Europe, though, the country has been losing ground, essentially to the benefit of the UK and the countries of Eastern Europe, according to the latest biennial analysis by the French pharmaceutical industry association Leem (Les enterprises du medicament).

The Leem study covers Phase II and Phase III clinical trials conducted for marketing authorisation purposes between 1 January 2006 and 31 December 2007, where part of the trial was carried out in France. The data were drawn from 19 multinationals that together make up 62% of the French pharmaceutical market.

The geographical analysis included 385 of a total 457 reported trials, with 71 studies excluded for reasons such as the trial being confined to France or no French involvement in the programme. In terms of the number of patients recruited during the period under analysis, France accounted for 24,343 or 7.8% of the total worldwide – about the same proportion as when Leem conducted its last biennial review in 2006.

That put France behind the countries of Eastern Europe (e.g., Bulgaria, Croatia, Hungary, Czech Republic, Ukraine), which scooped up 18.1% of all the patients recruited, as well as the US (12.9% of patients) and ‘other’ Western European countries like Belgium, Ireland and Portugal (9.0%). France was ahead of countries and regions such as Germany (7.6%), Latin America (7.5%) and Asia (7.2%) in the recruitment stakes.

While the French share remained more or less stable, the proportion of patients recruited in Eastern Europe swelled from around 15% in the 2006 analysis to 18% in 2008, Leem pointed out. By contrast, the US share of patients recruited dropped from around 17% in 2006 to 13% in 2008. The UK saw its recruitment share improve from 3% to 5%, while Asia’s share went up from 4% to 7%.

Looked at on a purely European level, France’s share of trial recruitment over the two analysis periods dropped from 14% to 12%, while Germany’s share declined from 15% to 12%. By contrast, the countries of Eastern Europe moved up from 25% to 29% and the UK took an 8% share of all patients recruited in Europe during the latest review period, compared with 5% in the 2006 report.

According to the Leem survey, France seems to fare better in European terms as a site for Phase I trials. Out of the 550 Phase I studies conducted by the polled companies (13 of which responded to this enquiry) in Europe, 199 or 36% were carried out in France compared with 171 in the UK, 143 in the ‘other’ Western European countries, 131 in Germany and 71 in Italy.

Progress made

The Leem data also show that France has made progress since the last survey on various measures of clinical trial engagement – although not as much progress as its European counterparts.

For example, the average number of patients recruited per trial by Europe as a whole was 70 in the latest survey compared with 46 in the 2006 analysis. France was below that average, also recruiting 46 patients per study in 2006 but managing only 63 per study in 2008.

Similarly, in terms of recruitment speed Europe as a whole improved from 1.7 patients per active trial centre per month in the 2006 survey to 2.8 patients on average in 2008. France boosted its per-month tally from 1.4 patients per centre in 2006 to 2.2 patients per centre in 2008. The country did come in above average on speed of recruitment for Phase IIa trials, where it managed 6.2 patients per active centre in 2008 against a European average of 5 patients per centre.

Among the recommendations made by Leem for improving the clinical trial environment in France are more efficient organisation of clinical research, effected through hospital reform and through CeNGEPS (Centre National de Gestion des Essais de Produits de Santé), the national agency officially launched in May 2007 to manage clinical trials in France and reinforce the country’s appeal as a study destination; and further raising the sector’s professional profile by, for example, creating hospital teams dedicated to clinical research.