The research contradicts the belief, expressed by leading contract research organisations (CRO) when cutting Phase I capacity, that early phase demand is down across the early stage trial industry.
“[Large CROs] think the Phase I business has simply gone downhill but we’ve found demand is at least stable”, Kevin Olson, president of ISR Reports, told Outsourcing-Pharma. Instead, Olson thinks what big CROs see as a sector-wide slump is actually a shift in outsourcing spend towards niche providers.
Olson based his claim on a survey of more than 100 Phase I decision makers at pharmaceutical and biotech companies. More than four-fifths of respondents said early stage trials are increasingly complex, with patients now included more often, and this is affecting outsourcing choices.
The rise of complex Phase I trials is occurring in parallel with greater sponsor reliance on service provider expertise and these factors, Olson said, are helping niche providers win business. Academic medical centres are also being used more often in Phase I but Olson can only speculate why.
Large CROs have acknowledged both the need to have expertise and the shift, noted by two-thirds of respondents, towards greater use of patients in Phase I. When discussing its early stage cuts in June Parexel emphasised the need to retain access to patient populations while reducing overall capacity.
Parexel said closer collaboration with external clinical trial sites will help. External partners, such as universities, can also give CROs access to niche expertise without adding a fixed cost. Icon is pursuing this model at its Phase I site in Manchester, UK and in alliance with Boston Clinical Research Institute.
Globalisation
Another element to clinical trials becoming more complex is the rise, observed by more than half of respondents, of global, multi-site Phase I studies. Large CROs with global footprints could benefit from this trend and evidence of this is beginning to emerge.
In recent quarters leading CROs have spoken of increased interest in more strategic Phase I deals and last month Bristol-Myers Squibb added weight to the talk by selecting Icon as a preferred provider. This trend, coupled to continued globalisation, should benefit CROs with scale and geographic reach.
“Sponsors tell us that India is likely to see a meaningful bump in Phase I studies”, Olson said. Indian regulations restrict Phase I for new drug substances discovered in other countries but sponsors and CROs continue to show an interest. In January Quintiles opened a Phase I unit in Hyderabad, India.