Editor's Note: High-quality clinical research is an essential foundation for advancing medicine and improving patient outcomes. In urology, establishing robust top-level research design and end-to-end quality control, transforming large volumes of clinical records into standardized and usable research data, and helping young physicians identify research opportunities amid demanding clinical workloads have become important priorities in disciplinary development. In this issue of Oncology Frontier · UroStream, Professor Yanbo Wang of the First Hospital of Jilin University discusses the full-process quality control of clinical research in urology, clinical database development and data governance, as well as pathways for young physicians to develop their research careers, sharing practical experience and insights into building a high-quality clinical research system.Establishing Top-Level Design and End-to-End Quality Control to Lay the Foundation for High-Quality Clinical Research
Oncology Frontier · UroStream: For clinical research in urology, which stages—from study design and cohort establishment to data quality control and translation of research findings—are critical to determining research quality? What experience and recommendations would you like to share?
Professor Yanbo Wang: The entire clinical research process can broadly be divided into two areas: first, study design, cohort establishment, and data quality control; and second, the translation and application of research findings.
At the early stage of research, a scientific and rigorous study design is the primary factor determining research quality. Only with sound top-level design can a study start from a strong foundation. For example, in a prospective clinical study, an inaccurate sample-size calculation or a mismatch between the research hypothesis and study objective—for instance, implementing a superiority study design when a non-inferiority design is actually required—could result not only in unnecessary expenditure of samples and research resources but also in the failure to achieve the intended study objectives.
It is important to emphasize that a high-quality research protocol should not rely solely on statisticians to determine sample size and eligibility criteria. Its fundamental prerequisite is that clinical researchers have a thorough understanding of the latest developments, clinical needs, and unresolved questions in their field. Researchers should begin with clinical hotspots and real-world problems, identify meaningful scientific questions, and then work with statistical and methodological experts to refine the study protocol. Only by combining clinical thinking with rigorous methodological design can truly high-quality clinical research be generated.
Second, data quality control during study implementation is equally critical. Even with an excellent study protocol, the ability to efficiently enroll patients and ensure that every participant’s information is authentic, complete, accurate, and traceable directly determines whether the study can progress smoothly and ultimately be completed. Therefore, a quality-control system covering patient screening, enrollment, diagnosis and treatment, follow-up, and data entry should be established.
Finally, there is the issue of translating research findings into practice. Obtaining preliminary results or even publishing a paper does not mean that the full value of a clinical study has been realized. Moving research findings into clinical practice is often a lengthy process. This is particularly true for drug- and medical-device-related research. Even when favorable clinical results have been obtained, bringing a product from the laboratory into clinical practice and ultimately benefiting more patients requires coordinated efforts from policymakers, industry, investors, medical institutions, and other stakeholders. Systematic development and implementation are essential for completing the process of translation.
Breaking Down Data Silos and Unlocking the Value of Clinical Data Through Standardized Governance
Oncology Frontier · UroStream: What key issues should receive particular attention when developing clinical databases and implementing data governance in urology?
Professor Yanbo Wang: Overall, clinical database development in urology in China is still at a relatively early stage. Some major medical centers in cities such as Beijing, Shanghai, and Guangzhou began exploring this area relatively early, but many hospitals have yet to establish mature specialty databases or have only recently begun this work.
To fully unlock the value of clinical data in urology, we need not only to organize and utilize existing historical data but also to continuously collect new data in a standardized manner. Specifically, I believe several areas deserve particular attention.
First, we need to break down barriers between different information systems. At present, electronic medical-record systems, laboratory systems, imaging systems, genetic-testing platforms, and biobanks are often operated independently within hospitals, creating varying degrees of “data silos.” Clinical database development must first address interoperability and data integration across these systems, bringing together medical records, laboratory tests, imaging, pathology, molecular testing, treatment, and follow-up information to establish a continuous and comprehensive clinical data chain.
Second, we should promote pre-formatting of clinical records and move data collection upstream. Traditionally, clinical research often begins after study initiation, with researchers retrospectively organizing information from existing medical records. This is labor-intensive and susceptible to missing data and information bias.
A better approach is to introduce structured and standardized data entry at the front end of clinical care, including medical history, operative records, pathological findings, and follow-up information. In this way, routine clinical care itself becomes a process of high-quality data accumulation, safeguarding the authenticity, completeness, and validity of data from the outset.
Third, medical terminology should be standardized and data-governance procedures should be formalized. Different physicians may vary in their documentation habits, disease descriptions, and use of professional terminology. Therefore, standardized terminology libraries and data dictionaries are needed to normalize heterogeneous data originating from different sources and stored in different formats.
China has a very large patient population and abundant clinical resources. However, it is important to recognize that “a large volume of data” does not automatically constitute true “big data.” Only after systematic collection, standardized cleaning, structured extraction, and comprehensive governance can vast amounts of clinical information be transformed into research resources that are analyzable, shareable, and verifiable.
This will provide a stronger foundation for high-level clinical research and further enhance the international academic influence and voice of Chinese urology research.
Starting from Real-World Clinical Questions: Building a Sustainable Research Pathway for Young Physicians
Oncology Frontier · UroStream: Young urologists working on the clinical front line often face multiple challenges, including limited time and resources as well as gaps in methodological expertise. What entry points would you recommend for them to gradually develop high-quality clinical research?
Professor Yanbo Wang: Young physicians, particularly those working in tertiary teaching hospitals, are often required to balance clinical care, research, and teaching. The pressure is indeed substantial. Nevertheless, an excellent clinician should still attach importance to and remain committed to clinical research.
In fact, every patient we see and every operation we perform provides an opportunity to identify clinical questions and accumulate research data.
First, young physicians should attach great importance to the standardized accumulation of original clinical data. Medical histories and medical records must be authentic, accurate, and complete. High-quality clinical research does not begin with statistical analysis; it begins with every properly documented clinical encounter. Without complete and reliable source data, subsequent research has no solid foundation.
Second, the research direction should not be overly broad. Young physicians should identify a focused area as early as possible and continue to develop expertise in it. Rather than dividing their attention among adrenal disease, prostate cancer, bladder cancer, kidney cancer, and other areas simultaneously, they should consider their team’s clinical resources, personal interests, and institutional strengths and establish a relatively stable research field—ideally narrowing it further to a specific question within a particular disease.
Long-term accumulation is more conducive to developing systematic research findings and establishing an individual academic identity.
In terms of research methodology, it is important to progress step by step. Early on, young physicians can begin with case reports, case series, single-center retrospective cohorts, and case-control studies. Through these projects, they can become familiar with study design, data organization, and manuscript preparation.
As their experience grows, they can progress to single-center exploratory phase II studies or small randomized controlled trials. Once the research team, patient resources, and organizational capabilities have matured, they can take the lead in or participate in domestic and international multicenter clinical studies.
At the same time, young physicians should actively strengthen their foundations in statistics and clinical research methodology. They should understand sample-size calculation, bias control, and the appropriate application of different statistical methods, rather than relying entirely on statisticians only after data collection has been completed.
I also recommend establishing a relatively stable small research team whenever possible. Through appropriate division of responsibilities, teams can improve the efficiency of patient screening, data entry, and follow-up management.
Long-term, standardized follow-up is particularly important in oncology research. Only through systematic collection of preoperative information, intraoperative data, postoperative pathological findings, and longitudinal follow-up can we obtain complete efficacy and prognostic data.
As long as young physicians remain grounded in real clinical questions, choose a clear and focused research direction, and maintain standardized documentation and long-term accumulation, they can gradually conduct high-quality clinical research and ultimately produce findings with genuine clinical value and academic impact.
Conclusion
High-quality clinical research is not the product of any single step. It results from the coordinated integration of scientific question formulation, study design, cohort development, data quality control, long-term follow-up, and translation of research findings into practice.
Looking ahead, urology needs to further strengthen specialty databases and standardized data-governance systems, transforming abundant clinical resources into high-quality scientific evidence.
For young physicians, research should not be viewed as an additional task detached from clinical practice. Rather, it should be a systematic way of summarizing clinical experience and scientifically answering real-world clinical questions.
By starting with the standardized documentation of every patient, maintaining a focused research direction, progressing step by step, and accumulating expertise over the long term, young urologists can continuously strengthen their clinical research capabilities and contribute high-quality evidence to the advancement of urology and improved patient outcomes.
Professor Yanbo Wang
