As reported in Biospectrum Asia, a new program sponsored by Eli Lilly and CRO Parexel will bring high-value training opportunities to China’s critical trial sites and investigators. The Chinese government is promoting major growth in their nation’s clinical research sector including policies resulting in sharp increases in clinical trials in the world’s most populous nation. Biospectrum Asia reports that there is a sharp increase in the number of clinical trials in China. According to China’s clinical trial registration platform, 1,258 drug clinical trials were registered and publicized for the first time in China in 2017, an increase of 62.66 percent compared to 2016. This increase in clinical research demands has put a strain on the clinical research capacity and resources in that nation.
Lilly and Parexel are clearly seeking to establish competitive differentiation-capitalizing on this growth by initiating high-value training developed by the PAREXEL Academy for clinical trials investigators and issue certifications to professionals who complete the training. The training material has been trained by clinical research practitioners and includes curriculum combining the latest policies, regulations and clinical research technologies. Other elements of the program include behavioral oriented curriculum design, real-world cases, as well as advanced knowledge and industry trends in order to provide world-class expertise and practical experience for clinical research and investigators. Eli Lilly and Parexel have had the curriculum “reviewed by Transcelerate BioPharma Inc,” an industry consortia-based non-profit in what appears to be an attempt to secure a form of stamp of approval.
There are a number of different certification and accreditation organizations in the clinical trials market that could be also utilized throughout China. Moreover, there are various accreditation approaches as well that could raise the clinical research bar in China. Accreditation of clinical research sites will be a vital process moving forward. In clinical research, high-performing, high-impact research sites are critical for high quality, effective and efficient performing clinical research value chain.
Rapidly growing emerging clinical trial markets will benefit from an emerging global clinical research site accreditation standard developed by the Alliance for Clinical Research Excellence and Safety (ACRES). This global clinical research accreditation standard was developed by a large group of deep industry experts—influenced by holistic systems thinking—that is factoring in complex endeavors as integrated sets of components that are connected, interoperable and working together synergistically. The ACRES global clinical research accreditation is now being adopted by a first wave of major clinical research sites and centers. At the time of writing TrialSite News is aware that a number of Asian research centers are interested in the ACRES accreditation standard.
Regardless of approach—whether via a collaboration of commercial sponsor and CRO to a comprehensive global standard research site accreditation, China will benefit from greater training and education involving policies, processes, compliance, quality assurance and related elements.