Why perform and publish clinical trials in China?—role of surgeons-scientists

According to a recent viewpoint in JAMA Surgery (1), the number of National Institutes of Health (NIH)–funded surgeon-scientists is dwindling in the United States (2,3): reasons include decreased NIH funding, diminished clinical demand and incentives, a lack of mentors, and high administrative burden (4). Combined with stiffer competition, many potential surgeon-scientists have become discouraged and slackened the pace of performing and/or participating in clinical trials (2,5,6).

Clinical trials are studies that test new or comparative drug or biological products, diagnostic, surgical, or radiological procedures, medical devices, and new technologies, among others, to evaluate their efficacy and effectiveness on human health outcomes. Along with the approval of the concept and goals by ethical and administrative commissions, they must be carefully conceived, planned, vetted, and monitored by the investigators during their execution. People of all ages, all countries, and all walks of life can volunteer to take part in clinical trials: therefore, ethical considerations and safety (avoiding harm to users and making sure that the treatment works or is not useless) are high on the priority list for investigators when clinical trials are undertaken.

Not only do clinical trials test or compare the effectiveness of therapies, diagnostic investigations, procedures, techniques, but the information they provide contributes to our knowledge of disease (improving the care we provide); they can also pave future roads of research to even higher achievements. Subgroups that fit a specific group of patients so-called personalized medicine can be gleaned from large clinical trials. This approach is essential to reduce excessive time and money spent on ineffective or unfounded research as well as avoiding undesirable side effects.

The Asian continent covers nearly one-third of land and accounts for nearly 60% of the world population. According to various sources (https://www.worldometers.info/world-population/asia-population/; https://www.statista.com/statistics/1364308/china-number-of-healthcare-institutions/), in the next quarter of a century, Asia’s population count is expected to topple 9.5 billion. Taking the example of gastric cancer (GC), China has been cited to account for almost 24% of new cases worldwide (7). Up to April 2022, a total of 83 GC-related clinical trials were conducted in mainland China, 79.5% being single-center studies (8).

China counts 4.8 million licensed physicians, and more than one million healthcare facilities, with nearly 95% being primary institutions such as ours (Ruijin Hospital in Shanghai). With such large volumes and numbers, one can easily imagine the wealth of potential research projects and publications emanating from China.

As the map of clinical research entities spreads over the globe, we have to be aware of the cultural differences between the East and West that may intervene in the ethics and conduct of clinical research. Identifying and recognizing these potential obstacles to conducting effective clinical research is an essential but understudied link to global medical care. Several countries both in Asia and the West have well-organized agencies that oversee clinical research and are the official voices for final approval and use to the public. However, we, as care-takers, having the responsibility of deciding or suggesting options for others, must be conscious of the overarching consequences of our personal ideas, feelings and conduct when involved in clinical research, beyond the rules and regulations of such agencies. We all know that one’s ego, personal advantages, promotions, or financial considerations cannot be completely relinquished to the second rank, but they must be pondered in such a way that they do not interfere with the goals or the ethical conduct of clinical research. Ethically faultless, safe and methodologically sound clinical research is a key complementary component to our vocation as care-takers.

The outcomes of clinical research must translate into improved clinical care to justify the major investments it requires the so-called “second translational research gap” (9). This means the dissemination of positive trial results but also stronger educational endeavors on our part. We must cultivate the importance of clinical research, and its publication in the mindset of our mentees. We also need to communicate the above-mentioned ethical considerations when we teach how to set up and conduct clinical trials. Clinical research without any (written) trace is incomplete. Teaching medical writing is essential and publication of clinical research is an inevitable component of clinical research. Considerable and continuous efforts have been made by the government but also by individual physicians to improve and uphold high standards of ethics and scientific integrity in research which may have suffered from inadvertent, ill-informed incentives and cultural lacunes in the past. China is becoming a leader in clinical research and publications. We applaud these efforts here and are proud to consider ourselves as part of this battle at Ruijin Hospital, Jiao Tong University, Shanghai. As well, with the help of goodwill platforms such as AME publishing company, the level of clinical research will continue to rise and shine in China and find its well-deserved award in the world medical-scientific community.

Acknowledgments

None.

Footnote

Provenance and Peer Review: This article was a standard submission to the journal. The article has undergone external peer review.

Peer Review File: Available at https://ales.amegroups.com/article/view/10.21037/ales-25-7/prf

Funding: None.

Conflicts of Interest: Both authors have completed the ICMJE uniform disclosure form (available at https://ales.amegroups.com/article/view/10.21037/ales-25-7/coif). M.Z. and A.F. serve as the co-Editors-in-Chief of Annals of Laparoscopic and Endoscopic Surgery from April 2016 to April 2026. The authors have no other conflicts of interest to declare.

Ethical Statement: The authors are accountable for all aspects of the work in ensuring that questions related to the accuracy or integrity of any part of the work are appropriately investigated and resolved.

Open Access Statement: This is an Open Access article distributed in accordance with the Creative Commons Attribution-NonCommercial-NoDerivs 4.0 International License (CC BY-NC-ND 4.0), which permits the non-commercial replication and distribution of the article with the strict proviso that no changes or edits are made and the original work is properly cited (including links to both the formal publication through the relevant DOI and the license). See: https://creativecommons.org/licenses/by-nc-nd/4.0/.

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