Microdosing or Phase 0 trials could become a crucial phase of drug development in years to come, suggests a new study.

Moreover, the associated emergence of niche capability providers in preclinical testing may lead to a number of partnerships and alliances, fuelling growth opportunities in the contract research sector.

Phase O studies involve testing trace doses (e.g., 1% or 100 micrograms of the pharmacological dose) in humans to evaluate pharmacokinetics and drug metabolism before a new compound enters Phase I trials. The aim is to speed up drug discovery, identify failures sooner and cut study costs by weeding out candidates with short half-lives or poor bioavailability.

A study by Frost & Sullivan, Strategic Analysis of Opportunities in the CRO Market – Phase 0, notes the increasing acceptance of microdosing and suggests it may be the antidote to industry’s much-discussed problems with drug productivity.

“There is every reason to believe that the solution for faster screening of candidates and increasing pressure on costs is gaining momentum in the right direction,” said senior research analyst V. Sriram. “The compelling advantages of microdosing present it as a potential remedy for big pharma’s maladies regarding declining returns from investments in drug development.”

Developments in microdosing should also create new opportunities for contract research organisations (CROs), Frost & Sullivan believes. Historically, alliances between CROs in the US and Europe have been thin on the ground, it notes, putting this down to strong growth and relatively low technology demands for clinical testing.

However, consolidation among CROs has raised concerns about quality of service and attention to detail in the sector, Frost & Sullivan points out. Companies need to ensure these elements are in place if they are to maintain their bargaining power with the pharmaceutical industry.
“CROs face the challenge of competitively aligning their services to meet customer needs in order to overcome the threat of losing their stronghold and loyalty,” Sriram commented.