The skyline of the Huangpu River in Shanghai. [Photo by Gao Erqiang/China Daily]

Shanghai has unveiled a set of guidelines that aim to propel the city's clinical research system and bolster the biopharmaceutical industry, one of the three major leading industries the city is keen on developing, alongside the integrated circuits and artificial intelligence sectors.

Effective from Aug 1, 2024, to July 31, 2029, these guidelines strive to drive high-quality advancements and innovation in biomedicine. They put forth a strategic vision to harness the strengths of top-tier hospitals in establishing a robust clinical research system centered around cutting-edge research platforms.

These platforms will encompass national medical centers, national clinical research centers, traditional Chinese medicine clinical research bases, and key national laboratories, with a goal to establish two to four leading clinical research platforms by 2025.

A pivotal component of the guidelines is the establishment of a municipal center dedicated to promoting and managing the quality of clinical research. They also advocate for the standardization of clinical research centers within hospitals and the enhancement of operational standards. To ensure adherence to quality and compliance, annual comprehensive inspections of clinical trial institutions will be conducted.

Encouraging collaboration across disciplines and institutions, these guidelines emphasize the formation of cross-disciplinary innovation teams involving medical institutions, universities, and research institutes. This collaborative effort seeks to expedite the translation of fundamental research discoveries into clinical applications, particularly in areas such as genomics, synthetic biology, and gene editing.

Furthermore, the guidelines advocate for the integration of clinical research into the strategic development plans of top-tier hospitals, supporting their evolution into research-oriented institutions with a focus on clinical innovation. Hospitals will be incentivized to allocate 10 percent of their beds for research purposes.

To nurture talent and incentivize excellence, mechanisms for identifying, training, and rewarding strategic scientists and leading clinical research professionals will be strengthened. The guidelines also highlight the importance of recruiting dedicated research personnel and providing academic leave for clinical researchers. Training programs will be implemented to cultivate a skilled workforce comprising research-oriented doctors, nurses, and support staff.

In a bid to drive innovation, the guidelines underscore the importance of prioritizing the clinical trials of innovative drugs and devices in hospital performance evaluations. Financial support will be extended to local medical institutions conducting clinical trials, with priority given to high-impact projects.

Efforts will be made to streamline ethical review processes and enhance the efficiency of ethical review committees. A city-wide health data integration platform will be developed to facilitate data sharing and support clinical research and policy development.

Moreover, the guidelines advocate for the commercialization of clinical research findings through pilot reforms and the establishment of professional service platforms. The establishment of the Shanghai Clinical Innovation and Transformation Research Institute will further support the commercialization of high-quality research outcomes.

To ensure sustainable funding for clinical research, the guidelines propose leveraging financial support from both government and private sources. Mechanisms such as public funds, charitable donations, and venture capital will be utilized to establish a robust funding model for clinical research.

The Shanghai Municipal Health Commission, in collaboration with other pertinent departments, will oversee the implementation of these guidelines. Regular performance evaluations will be conducted to monitor the effective execution of these initiatives, fostering an environment that is conducive to innovation and high-quality development in the biopharmaceutical sector.

Source: shanghai.gov.cn