Using an innovative accelerated proof-of-concept design (AcPOC) for Phase I and II clinical trials can cut study timelines by 50% and costs by more than 10%, says Cetero Research, the US-based company that provides clinical pharmacology, bioanalytical and speciality Phase II-IV trial services.

The AcPOC design combines into one trial single ascending dose (SAD), multiple ascending dose (MAD), preliminary food effect and POC studies. Researchers get valuable insight into the viability of drug candidates within 14 to 19 weeks, compared with the 28 to 36 weeks it may take to run these four studies sequentially, notes Cetero, which claims to be “the leading contract research organisation in early-stage research services”.

In an AcPOC trial the company ran for a ‘major pharmaceutical company’ with an allergy treatment, the time from First Patient, First Visit (FPFV) to top-line proof-of-concept results was 16 weeks, against an average of 38 weeks to run the trials separately, Cetero added. In another AcPOC trial for an obesity treatment, the time from FPFV to top-line results was 12 weeks, including the full range of SAD, MAD, preliminary food effect and POC studies.

“There is tremendous pressure on pharmaceutical and biotech companies to save money while still providing safe and effective treatments,” pointed out Dr Troy McCall, chief executive officer of Cetero Research.

“For small and mid-sized firms, the need to establish POC is essential in securing financing or hitting the next milestone payment,” he added. “For larger companies, there is an increased need to replace drug patents that are set to expire soon. The uncertainty of the US healthcare reform bill also has big pharma companies looking at every area of their business.”

According to Dr Graham Wood, president of clinical operations for Cetero’s facilities in Toronto, Canada and Miami, US, organisations “can see huge savings in the amount of staff training time and time to implement the study when they use the AcPOC approach”.

Running four separate studies can require up to four different groups of employees, he noted. The AcPOC design allows the same group to administer the study from start to finish, “providing seamless continuity."

Additional benefits include a more streamlined process, with one comprehensive study protocol, one document for regulatory approval, and consistent data from one source in one format, Cetero said. Study sponsors also have “the convenience of being able to see several trial phases in one trip versus having to make multiple trips to the study facility”.