Clinical outsourcing more common in early stages

Survey data gathered by Cutting Edge information shows that on average, 54.6 per cent of clinical trial staff allocation is outsourced by sponsors in Phase I, dropping slightly to 47.3 per cent in Phase II.

Many trial sponsors, particularly small biotechs, do not have the appropriate in-house facilities or resources to run such trials.

As a result, early phase clinical trial services are a strong growth area and because there are only a limited number of firms with specialist capabilities in this field, they continue to be one of the biggest bottlenecks in the development of new drugs.

The later phases of drug development (III and IV) see a dramatic downward shift in staff allocation being outsourced, at only 27.1 per cent and 27.5 per cent respectively, according to the report, titled: "Clinical Operations: Accelerating Trials, Allocating Resources and Measuring Performance."

Meanwhile, the study also showed that Vendor fees are now the biggest financial burden for sponsors when conducting clinical trials.

Pushed out of the 2004 top spot was patient recruitment, which was relegated to third, followed by investigator fees in second place, according to research by Cutting Edge Information.

In 2004, patient recruitment attracted the highest score - 3.8 out of 5 - in a survey by Cutting Edge of pharmaceutical executives who were asked to rate factors contributing to the rising costs of clinical trials.

At the time vendor fees attracted a rating of 3.6 and investigator fees were not measured.

Cutting Edge's 2006 survey data, however, now shows that vendor fees has leaped into the top slot, with a new rating of 4.1, while investigator fees was close behind on 4.0 and patient recruitment remained steady on 3.8.