Introduction
This year, the Regulation on the Administration of Clinical Research and Clinical Translation of New Biomedical Technologies (State Council Decree No. 818; hereinafter referred to as the “Regulation”) officially came into effect. For new technologies involving human cells and molecules, including cell therapy, gene therapy, tissue engineering, and other emerging biomedical technologies, the Regulation not only establishes a new compliance pathway but also, to some extent, helps streamline the clinical research process [1].
However, a faster process does not mean lower standards.
While encouraging innovation, the Regulation establishes clear requirements for scientific evidence, ethical principles, protection of research participants, safety management throughout the research process, and data integrity. The implementation notice further emphasizes that clinical research data quality is a fundamental basis for supporting the clinical translation of new biomedical technologies, and that research results and data must be authentic, complete, and traceable [2].
Therefore, the real question raised by the Regulation is not how to enroll participants as quickly as possible, but how to generate credible evidence more efficiently without compromising scientific rigor, ethical standards, or data verifiability.
Clinical research can be accelerated, but research quality cannot be compromised. This should be a fundamental principle shared by all sponsors, research institutions, and service providers under the new regulatory framework.
Understanding this principle requires first distinguishing what can be accelerated from what cannot be compressed. Processes that can be accelerated include pathway determination, document preparation, contract negotiation, site selection, coordination between academic and ethics reviews, system submissions, and waiting and rework during cross-functional communication. What cannot be compressed includes necessary nonclinical evidence, technical quality control, scientific justification of the study design, participant protection, investigator training, safety monitoring, source data generation, statistical analysis, and long-term follow-up.
The National Health Commission’s guidance on the classification of new biomedical technologies emphasizes that early-stage new biomedical technologies should have clearly defined mechanisms and principles, sufficient preliminary evidence, and demonstrated safety and efficacy adequate to support the initiation of clinical research [3]. This means that filing is not an exemption from scientific requirements. Instead, it places greater responsibility for pathway determination and quality management on sponsors and research institutions at an earlier stage.
The Regulation also stipulates that filed projects will be subject to evaluation by professional institutions. Where technical or ethical risks are identified, projects may be required to suspend the research or amend the protocol; projects involving major risks should be terminated [1].
Therefore, filing is not a one-time “pass,” but the starting point of dynamic oversight.
A project that focuses solely on submitting as early as possible without adequately addressing its technical characteristics, evidence gaps, study design, and risk controls may appear to save several weeks initially, but could ultimately lose much more time due to additional requirements, amendments, suspension, or unusable study data. True acceleration does not mean eliminating necessary work; it means completing the required work at the right time and in the right sequence.
1. Quality Is Not a Post-Study Check—It Begins with Study Design
High-quality clinical research starts with high-quality research questions and a high-quality protocol, rather than relying on a final round of “data supplementation” before study completion. ICH E6(R3) establishes “quality by design” as an important principle of modern clinical research, requiring the identification of critical quality factors that directly affect participant protection and the reliability and interpretability of study results, and the use of risk-proportionate approaches to manage them [4]. The WHO guidance on best practices for clinical trials likewise identifies good design, good conduct, ethics, and transparency as common foundations for reducing research waste and improving efficiency [5].
This principle is particularly important for new biomedical technologies. Many such technologies are highly dependent on operational procedures, may involve substantial batch-to-batch or inter-individual variability, have uncertain long-term risks, may be difficult to blind, and may be studied in relatively small populations. If the study objectives, target population, intervention procedures, control strategy, primary endpoints, and statistical assumptions are not clearly defined during protocol development, even highly standardized execution cannot turn a fundamentally inadequate study into confirmatory evidence.
The Technical Guideline for Confirmatory Clinical Research on New Biomedical Technologies (Draft for Public Comment) proposes that confirmatory studies should prospectively define the study hypothesis, primary endpoints, control strategy, statistical analysis plan, and measures for bias control, while giving priority to randomized, controlled, blinded, or assessor-blinded designs. For studies intended to support clinical translation, the guideline also proposes demonstrating that different sites can independently implement the study according to standardized operating procedures and obtain consistent safety and efficacy conclusions [6].
Although this document remains a draft for public comment, it clearly illustrates the direction of evidence evaluation: the focus is shifting from simply asking whether a clinical study has been conducted to determining whether the study is sufficient to answer questions regarding clinical value, benefit-risk, and reproducible implementation.
2. True Speed Comes from Upfront Planning, Parallel Collaboration, and Risk Focus
Quality and speed are not inherently in conflict. Low-quality studies are often slow not because the requirements are too demanding, but because comprehensive planning is lacking at the early stage. For example, a protocol may be drafted before the technical pathway has been confirmed; statisticians may only become involved after the protocol has been finalized; inconsistencies between informed consent materials and the risk management plan may only be discovered immediately before ethics submission; site training may only be completed after the first participant has been enrolled; source data locations may only be discussed after database development; and the ability of the data to support clinical translation may only be considered after study completion. Every late discovery can lead to repeated revisions, site delays, and gaps in the evidence chain.
A more effective approach is to establish a comprehensive roadmap from objectives to evidence, from evidence to data, and from data to operational processes at the beginning of the project:
First, determine whether the technology falls under the pathway for new biomedical technologies, pharmaceuticals, or medical devices, and then clarify whether the study is an exploratory validation study or a confirmatory study intended to support clinical translation;
Simultaneously organize medical, nonclinical, technical quality, statistics, data management, clinical operations, and regulatory teams to conduct a gap analysis;
Work backward from key decision questions to define endpoints, controls, sample size, follow-up, and data collection requirements;
Once the protocol becomes sufficiently stable, proceed in parallel with site feasibility assessments, contract and budget discussions, database design, supply and sample workflows, investigator materials, and training materials.
Here, “parallel” does not mean starting everything prematurely or without coordination. It means eliminating unnecessary waiting time while maintaining clear dependencies, version control, and accountability.
3. Risk-Based Management Does Not Mean Doing Less Quality Management—It Means Focusing Resources Where They Matter Most
Ensuring research quality does not mean mechanically replicating every process used in pharmaceutical clinical trials across every early-stage project. An appropriate quality system should be proportionate to the technical risks, research objectives, and intended use of the evidence.
High-risk projects, irreversible interventions, projects involving long-term safety considerations, or projects intended to support clinical translation require more stringent site qualification assessments, more intensive early safety reviews, stronger controls over consistency in technical procedures, and more comprehensive long-term follow-up. By contrast, relatively low-risk studies intended primarily to evaluate early feasibility may reduce excessive verification of non-critical data and concentrate monitoring and data verification on informed consent, eligibility criteria, intervention implementation, critical quality attributes, primary endpoints, safety events, and protocol-defined stopping criteria.
In other words, the essence of risk-based management is not to reduce quality activities, but to prioritize participant protection and ensure the credibility of critical conclusions.
Before study initiation, the research team should establish a project-level quality management plan defining critical quality factors, acceptable ranges, risk signals, responsible personnel, and escalation pathways. During the study, indicators such as site performance, protocol deviations, data queries, safety events, sample failure rates, and follow-up completion rates should be continuously monitored. Intervening when a trend begins to deviate is far more efficient than conducting extensive remediation after study completion.
ICH E6(R3) advocates risk-based quality management proportionate to participant risk and data importance. Research teams should prospectively identify critical quality factors and focus limited quality management resources on areas that may materially affect participant rights and safety or the reliability of study results, rather than applying equal levels of effort to all data and processes [4].
4. Data Quality Is an Evidence Chain from Source to Conclusion
Data quality in new biomedical technology research should not be understood simply as complete data entry in the electronic case report form (eCRF). Cell manufacturing, gene editing, intervention procedures, sample collection and testing, imaging assessments, off-site follow-up, and long-term safety monitoring may take place across different systems, teams, and settings.
Without predefined source data, responsible personnel, timestamps, modification rules, and interface relationships, even a well-organized eCRF may fail to answer fundamental questions: Where did the data originate? Who made a particular assessment and when? Was the technology implemented according to requirements? Can the results be independently verified?
The Regulation requires timely, accurate, and complete documentation of clinical research activities and stipulates that records and original materials should, in principle, be retained for at least 30 years. It also prohibits falsifying, altering, concealing, or otherwise manipulating relevant records and materials [1].
Relevant research has also identified issues in some investigator-initiated trials (IITs) in China, including insufficient identification of source data, untraceable data modifications, difficulty verifying critical data, and weaknesses in process quality control and adverse event reporting. It recommends establishing traceable process records covering key milestones such as ethics review, protocol versions, personnel authorization and training, screening and enrollment, visits, protocol deviations, safety reporting, data queries, monitoring and remediation, database freeze, and statistical analysis [7].
Therefore, from the first day of a project, teams should establish an integrated system covering the data management plan, source data inventory, data flow diagram, coding and query rules, audit trails, database lock, and statistical analysis, while ensuring that technical quality records can be linked to clinical data. “Preparing data for submission” should not mean repackaging information after the study has ended. Instead, every critical conclusion should be supported from the outset by evidence that is authentic, complete, and traceable.
5. Participant Protection Is Not the Cost of Acceleration—It Is the Prerequisite for Sustainable Acceleration
New biomedical technologies often target patients with serious diseases, rare diseases, or limited effective treatment options. These patients may have high expectations for innovative therapies and may also be more vulnerable to therapeutic misconception.
The more urgent the clinical need, the more important it is to clearly explain the research nature of the study, unknown risks, alternative treatment options, the right to withdraw, compensation and treatment for research-related injuries, and the use of samples and personal information.
Ethics review should not be treated simply as a procedural step before clinical initiation. Instead, it should continue throughout protocol amendments, the emergence of new safety information, serious adverse events, changes in the benefit-risk profile, and long-term follow-up.
The Regulation requires that the research purpose, protocol, potential risks, and relevant rights be explained to participants in a manner they can understand. In the event of a serious adverse event, the research institution should suspend the study, and the ethics committee should assess whether the study should continue [1].
The implementation notice further requires that participants be recruited and enrolled according to the eligibility criteria specified in the protocol, that risks be promptly controlled and managed, and that arrangements be established for the treatment of research-related injuries and relevant protections [2].
These requirements do not hinder genuine innovation.
On the contrary, clearly defined stopping rules, rapid safety reporting channels, independent medical judgment, and adequate informed consent can reduce confusion when crises occur and build trust among participants, investigators, hospitals, and regulatory authorities. Without such trust, even the fastest study initiation will struggle to achieve sustainable clinical translation.
6. From “One Site Can Do It” to “Multiple Sites Can Reproduce It Consistently”
The clinical value of a new biomedical technology depends not only on whether an expert at a particular hospital can achieve positive results, but also on whether the technology can be standardized, trained, quality-controlled, and consistently implemented at other qualified institutions.
The Working Procedures for the Approval of Clinical Translation of New Biomedical Technologies (Trial Implementation) explicitly requires multi-center participation for applications for clinical translation and requires evidence that different sites can independently implement the technology in accordance with clinical application procedures and obtain consistent safety and efficacy conclusions. The approval assessment also considers technology maturity, quality control standards, institutional and personnel qualifications, and risk control measures, with on-site verification and assessment conducted when necessary [8].
This makes “transferability” an important component of research quality. If a sponsor relies solely on a single site with the strongest resources and the closest relationship with the technology team to complete early-stage research, without translating critical procedures into standardized processes that can be trained and verified, subsequent multi-center expansion may expose differences in personnel, equipment, sample logistics, and quality control.
A better strategy is to identify site capability requirements at an early stage and establish standard operating procedures, training and authorization systems, technical implementation checklists, site initiation verification, and ongoing competency reassessment. During multi-center studies, teams should evaluate not only efficacy and safety, but also consistency in technical implementation.
Although this approach may appear to increase upfront preparation, it ultimately reduces uncertainty during subsequent replication and regulatory assessment.
7. The Value of a Professional CRO Is to Turn “Fast and High-Quality” into an Executable System
Under the new regulatory framework, domestic legal entities, including enterprises, research institutions, and medical institutions, may serve as sponsors of clinical research. However, many sponsors do not naturally have comprehensive teams covering regulatory pathways, clinical methodology, site operations, biostatistics, data management, and quality management.
The value of a professional CRO is not to “take away” the responsibilities of sponsors or research institutions, but to help translate those responsibilities into clearly defined tasks, standards, and evidence.
Clin-nov can support projects at an early stage by assisting with technology classification and pathway assessment, regulatory gap analysis, and communication strategies with relevant professional institutions. With future clinical translation objectives in mind, Clin-nov can coordinate regulatory, medical, statistical, data management, and clinical operations teams to jointly optimize study protocols.
Clin-nov can also establish filing document checklists, version control systems, and submission plans, facilitating the orderly coordination of academic review, ethics review, institutional approval, and system filing.
During study execution, Clin-nov can identify deviations and reduce rework through site selection, investigator training, risk-based monitoring, project performance dashboards, safety information management, data cleaning, and closed-loop remediation.
At study completion, Clin-nov can help ensure logical consistency and traceability across the database, statistical analysis, study report, and evidence package for clinical translation.
For multi-center projects, Clin-nov can further translate technical procedures, sample workflows, quality control requirements, and safety management requirements into standardized processes that can be implemented consistently across sites. By coordinating differences between sites, Clin-nov helps research move from “an expert can perform it” toward “a system can reproduce it.”
The efficiency generated by these activities does not come from lowering standards, but from professional specialization, early decision-making, parallel collaboration, and consistent execution.
It should be emphasized that engaging a CRO does not alter the statutory responsibilities of the respective parties under the Regulation. High-quality collaboration should be supported by written agreements, responsibility matrices, communication mechanisms, and quality oversight to ensure that sponsors, research institutions, principal investigators, ethics committees, and CROs each fulfill their respective responsibilities and work together effectively [1,7]. Clin-nov has already established strategic collaborations with multiple leading clinical research institutions under the new regulatory framework, supporting them in end-to-end clinical research filing and clinical translation of new biomedical technologies.
Conclusion
The Regulation has opened a clearer pathway for new biomedical technologies to move from the laboratory to the clinic. However, a clearer pathway does not mean that fundamental principles can be overlooked.
The projects that will ultimately be most competitive are not necessarily those that complete filing first, but those that can continuously generate credible evidence with less waiting, less rework, and lower operational variability.
Process efficiency determines how quickly a study can begin, while research quality determines how far its results can go. The former addresses the issue of time; the latter determines value.
The balance between the two is neither exchanging quality for speed nor demonstrating quality through unnecessary procedural complexity. Instead, it means adhering to quality by design, risk-proportionate management, end-to-end data traceability, and participant protection as a priority, while ensuring that every critical task is performed by the right person at the right time.
Clin-nov aims to leverage its systematic capabilities as a professional CRO to help sponsors of clinical research translate the urgency of innovation into efficient execution and the rigor of research into credible evidence—enabling clinical research to be both faster and better, and helping valuable new biomedical technologies reach patients earlier and more safely.
References
[1] State Council of the People’s Republic of China. Regulation on the Administration of Clinical Research and Clinical Translation of New Biomedical Technologies (State Council Decree No. 818). Issued September 28, 2025; effective May 1, 2026.
[2] National Health Commission of the People’s Republic of China; National Disease Control and Prevention Administration. Notice on Matters Concerning the Implementation of the Regulation on the Administration of Clinical Research and Clinical Translation of New Biomedical Technologies. April 30, 2026.
[3] National Health Commission of the People’s Republic of China. Guiding Principles for the Classification of New Biomedical Technologies, Pharmaceuticals, and Medical Devices (Interim). National Health Science and Education Development [2026] No. 12, April 28, 2026.
[4] International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use. ICH E6(R3): Guideline for Good Clinical Practice. Final version, January 6, 2025.
[5] World Health Organization. Guidance for Best Practices for Clinical Trials. Geneva: WHO, 2024.
[6] National Health Commission of the People’s Republic of China. Technical Guideline for Confirmatory Clinical Research on New Biomedical Technologies (Draft for Public Comment). June 8, 2026.
[7] Guo JL, Gao JC, Bian LL, et al. Research on the regulatory system for investigator-initiated clinical research and its role in the context of new biomedical technologies. China Food and Drug Administration Magazine. 2026(5):52-61. DOI:10.3969/j.issn.1673-5390.2026.05.003.
[8] National Health Commission of the People’s Republic of China. Working Procedures for the Approval of Clinical Translation of New Biomedical Technologies (Trial Implementation). April 30, 2026.
[9] National Health Commission of the People’s Republic of China. Measures for the Administration of Investigator-Initiated Clinical Research Conducted by Medical and Health Institutions. National Health Science and Education Development [2024] No. 32, September 18, 2024.
[10] National Health Commission of the People’s Republic of China. Supporting and Promoting the Clinical Translation of New Biomedical Technologies through High-Quality Clinical Research to Benefit the Public. [EB/OL]. April 30, 2026.
