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, an early-stage contract research organization (CRO), announced its success in using an approach to Phase I and Phase II clinical trials to cut study time by 50 percent and reduce costs by more than 10 percent. The accelerated POC (AcPOC) study design combines single ascending dose (SAD), multiple ascending dose (MAD), preliminary food effect, and proof-of-concept (POC) studies into one.
"There is tremendous pressure on pharmaceutical and biotech companies to save money while still providing safe and effective treatments. The accelerated proof-of-concept design helps assess drug candidates more quickly and at less cost," said Dr. Troy McCall, CEO 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. For larger companies, there is an increased need to replace drug patents that are set to expire soon. The uncertainty of the U.S. health care reform bill also has big pharma companies looking at every area of their business."
With the AcPOC study design, researchers get insight into the viability of drug candidates within 14 to 18 weeks, compared to the 28 to 36 week timeframe it may take to run the four studies sequentially using standard study designs.
For an accelerated POC trial Cetero conducted for a major pharmaceutical company to study an allergy treatment, the time from First Patient, First Visit (FPFV) to top-line POC results was 16 weeks, compared to an average of 38 weeks to run the trials separately. This included SAD, MAD, preliminary food effect, and POC studies. In another AcPOC study for an obesity treatment, the time from FPFV to top-line results was 12 weeks to conduct the full range of SAD, MAD, preliminary food effect, and POC.
The design can be used for most therapeutic studies, including treatments for diabetes, obesity, dermatological conditions, allergies, and asthma. The time and money savings differ by therapeutic area as do the type of studies that need to be combined. The similarity is they all have a common goal of getting to POC as quickly as possible.
This all-in-one approach offers additional benefits, including a more streamlined process with one comprehensive study protocol, one document for regulatory approval, and consistent data from one source in one format. Study sponsors also have the abilithy to see several trial phases in one trip versus having to make multiple trips to the study facility.