SAN DIEGO -- SynteractHCR, a leading full-service global contract research organization (CRO), has completed validation and training on East®, Cytel's adaptive trial software, enhancing its consulting services on adaptive trials to its clients, especially for those smaller or emerging companies that may not have the resources to run adaptive trial simulations in-house. SynteractHCR now offers design, simulation and clinical execution services for adaptive trials.
The adaptive trial group at SynteractHCR works under the direction of Dr. Greg Wei , director of biostatistics. An expert on biostatistics for regulatory issues, Wei has more than 20 years of pharmaceutical and statistical experience. Wei has direct regulatory experience with the FDA and EMA, and has presented to both agencies on special protocol assessment and adaptive trial design, both of which are crucial areas for pharma and biotech companies as they are pressured to increase trial efficiency and reduce study costs.
Adaptive trial designs use accumulating data to modify trials under progress without undermining the integrity of the trials. They allow sponsors to adjust certain parameters such as dosage, subject population, or sample size in consideration of statistically significant safety or efficacy data. The goals are to accelerate clinical development and improve its efficiency, better target experimental drugs to responsive patient groups, and reduce the number of patients exposed to inappropriate or ineffective therapies. According to recent studies that have addressed the topic, adaptive trials save three months in trial duration on average but may save up to a year in the trial process.
According to Dr. Philip Doren, vice president, Biometrics at SynteractHCR, the inclusion of adaptive trials consulting is a critical component of the company's approach to global clinical trials and meeting the needs of its clients.
"Offering expanded adaptive trials capabilities is another step in providing individualized services tailored to our clients' specific needs," says Doren. "We continue to improve our technology capabilities as well as increase our depth in personnel who have the expertise that clients want to improve their trial efficiencies. Dr. Wei and his team will be able to help clients reduce cycle times and late stage attrition rates while managing the ethical considerations that are at the heart of everything we do."
Wei's experience with regulatory filings on several new drug applications and regulatory agency interaction provided a strong basis for his appointment to the position. Prior to joining SynteractHCR in autumn of 2012, Wei amassed his pharmaceutical experience at a wide range of international companies, including management experience as head of statistics at the China Research and Development Center, Pfizer, Inc. and as senior principal statistician of biostatistics at Boehringer-Ingelheim, director of biostatistics at Orexigen Therapeutics, and director of oncology statistics at Pfizer, Inc., Wei has been an avid user of East for sample size estimation for group sequential design, trial monitoring, interim analysis timing and power, conditional power calculation, and trial simulation for sample size change. He is also familiar with theory and software for continuous reassessment methods for dose-finding and for two-stage design for Phase II studies.
SynteractHCR has been formed from the merger of Synteract and Harrison Clinical Research (HCR), announced earlier this year. The newly expanded company operates from 16 locations worldwide and will provide top tier international capabilities to support clinical trials globally, from emerging products through post-marketing.
About SynteractHCR (www.synteracthcr.com)
SynteractHCR is a full-service contract research organization with a successful two-decade track record supporting biotechnology, medical device and pharmaceutical companies in all phases of clinical development. With its "Shared Work – Shared Vision" philosophy SynteractHCR provides customized Phase I through IV services collaboratively and cost effectively ensuring on-time delivery of quality data so clients get to decision points faster. Operating in 16 countries, SynteractHCR delivers trials internationally, offering expertise across multiple therapeutic areas including notable depth in oncology, CNS, infectious disease, endocrinology, cardiovascular, and respiratory, among other indications.