CARY, N.C., June 8 Cetero Research, the leading early-stage contract research organization (CRO), today announced its success in using an innovative 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. healthcare reform bill also has big pharma companies looking at every area of their business."
With the AcPOC study design, researchers get valuable 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.
"Organizations can see huge savings in the amount of staff training time and time to implement the study when they use the AcPOC approach," said Dr. Graham Wood, President of Clinical Operations for Cetero's Toronto and Miami facilities. "Four separate studies can require up to four different groups of employees. The AcPOC study allows the same group to administer the study from start to finish providing seamless continuity."
While Cetero has the most experience using the AcPOC approach with allergy and obesity studies, the design can be used for virtually any therapeutic study, 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 convenience of being able to see several trial phases in one trip versus having to make multiple trips to the study facility.
"The AcPOC study design provides organizations a lot of advantages, but it is very complex to design and plan correctly," added Dr. Wood. "Selecting a CRO like Cetero that has experience with this design, understands the therapeutic area, and has a database of both normal healthy participants and patients will help organizations realize the full benefits of this approach."
In addition to its expertise administering AcPOC studies, Cetero also offers a wide range of services to help support early-phase clinical trials including protocol writing, clinical conduct, bioanalysis, pharmacokinetics, data management, biostatistics, and medical writing.
About Cetero Research
Cetero Research is the leading contract research organization (CRO) in early-stage research services. With more than 25 years of experience from its founding companies, Cetero has conducted more than 10,000 clinical pharmacology studies - more than any other CRO. Cetero's proven track record allows the company to provide flexible and high-quality drug development services. The company's time-tested systems produce consistent and reliable data clients can trust. Cetero's clinical research expertise consists of traditional early-stage, healthy-volunteer clinical pharmacology and bioavailability studies, as well as specialty Phase Ia/b trials in patients. Its bioanalytical services support clinical, preclinical drug, and biomarker analysis for small and large molecules. In addition, Cetero owns and operates a full-scale central laboratory supporting Phase I-IV clinical trials in North and South America. For more information, visit www.cetero.com, or call 877.7CETERO.
For more information, please contact: April Johnson Vice President, Business Relationship Management Cetero Research Direct Line: 919-468-4214 Email: [email protected]
SOURCE Cetero Research