What Role will China Play as a Data Management Centre for Global Projects?

Tomotsugu Naoki, Research Associate Centre for Clinical Research, Keio University School of Medicine, speaks to Bryan Camoens from Pharma IQ, on the challenges in attaining data quality in global clinical trials. He also touches on China’s growing global role as a data management centre and the difference in data collection in Europe as well as Asia.

Pharma IQ: What are some of the challenges in managing global clinical trials data - data compliance and reporting?

T Naoki: In order to attain the data quality required in the global trials, it is of utmost importance to a) simplify the data entry screen of the EDC system, and b) to provide clear instructions for those dealing with data entry so that they can fully understand intentions and backgrounds for data collection in a given trial. Besides, we need to clarify in advance issues and challenges that differ in each country taking part in global trials; otherwise slight cross-cultural miscommunications can result in significant operational delays and mishaps.

Pharma IQ: What is the current regulatory environment and requirements for clinical trial data collection and management?

T Naoki: Most pharmaceutical companies in Japan already execute their trials by well validated, globally acceptable EDC systems, such as Medidata and PhaseForward. The Japanese regulatory agency PMDA (Pharmaceuticals and Medical Devices Agency) also approves electronic data as source document.

Pharma IQ: Could you please elaborate on the role of CROs in managing patient compliance and data?

T Naoki: R&D divisions in Japanese pharmaceutical companies have significant number of in-house CRAs, but have started to outsource more monitoring function to CROs. However, Japanese CROs are still in statu nascendi, thus leaving a number of areas to be improved further, including the quality of CRA services. In addition, efficient and tactful project management function in CROs, crucial in smooth trial implementation, is not necessarily provided to meet global standard.

On the other hand, Academic Research Organisations (AROs) have at long last been established, however few in number, and are seeking partnership with CROs so that the functions in relative paucity in academia, e.g. extensive field monitoring, timely AE handlings and entrepreneurship, can be duly supplemented by CROs. Given the present clinical development milieu in Japan, strategic partnership between ARO and CRO is believed to be most productive and promising to expedite successful participation in global trials, thereby decreasing developmental onus on the part of the sponsors.

Pharma IQ: What sort of a role will China play as a data management centre for global projects?

T Naoki: China has already become an indispensable key player in R&D in many ways, e.g. cost performance, efficient and extensive enrollment. In this respect it is only natural that many mega- pharmas have already been rushing to establish their data centres in China.

The future of developmental success in whole Asia rests heavily on whether China can ensure, maintain and further sophisticate data management functions, among other developmental capabilities.

Pharma IQ: How does data collection differ in Europe than Asia?

T Naoki: Data management minutiae per se, such as data retrieval by EDC system, do not seem to have significant differences to note regarding global trial management.

[inlinead]