Demonstrating safety is no longer the be-all and end-all of Phase I trials, says LCG Bioscience, the UK-based clinical research centre for exploratory and early-phase clinical development.

"We are now being asked to incorporate detailed assessments of drug effect into our first-in-human trials,” notes Dr Anthony Priestley, LCG Bioscience’s medical director. “With the increasing costs of development, sponsors need to be confident that a drug is active and produces the expected response before the most significant costs of development are incurred.”

That means trial designs are evolving to include detailed biomarker assessments, while there is demand for patient groups to be involved from the earliest stages.

Another, linked factor is time pressures on trial sponsors, which “seem to have intensified this year”, comments Justin Watts, director of operations for LCG Bioscience. “We are seeing shorter lead-times on trials and they are more varied,” he comments, citing in particular the need for special populations to enable early assessments of drug activity.

Whilst the growing complexity of early stage studies “does have a cost”, this investment “is recovered easily if the data allows for a more streamlined development plan”, Priestly adds. “Even the dreaded ‘kill’ decision can allow a company to refocus its resources onto better drugs.”

LCG Bioscience has been addressing these challenges through a diversified recruitment policy, which allows the company to provide “a fast response and flexible service” for complex trials. The strategy includes a network of general practitioners on exclusive patient-recruitment contracts and outpatient centres for study volunteers in Cambridgeshire and central London.

Another key advantage claimed by the company is the close integration of biomarker laboratories within its clinical facility. “This ensures the freshness of samples, as blood and other bodily fluids can be collected by specialist nurses and passed to laboratory staff within minutes,” LCG Bioscience explains. The company has also made significant investments in specialist technology such as flow cytometry and proteomics.

“Although biomarker technology is useful throughout the drug discovery and development process, it is increasingly being included in human trials from the outset,” observes Dr Rosalyn Forsey, biomarker specialist at LCG Bioscience. “This means that datasets are more complete and can provide support for internal decision-making.”