Breaking Through Bottlenecks: Enhancing Quality and Efficiency in Centralized Clinical Trials — Insights from Gao Jingtao of Beijing Chest Hospital
For a long time, Europe and the United States, home to numerous century-old pharmaceutical companies, have been the primary locations for clinical trials. As China’s pharmaceutical industry rises at an unprecedented pace, the domestic clinical trial market has recently experienced rapid growth, reaching an annual market size of RMB 10 billion. However, rising costs and increasingly lengthy time-to-market are dampening enthusiasm for drug development and limiting patients’ access to new therapies.
“Identifying barriers from the investigator’s perspective and implementing targeted measures to reduce burden and enhance empowerment is key to improving the quality and efficiency of clinical research within the current landscape of centralized clinical trials,” said Gao Jingtao, Deputy Director of the Clinical Center Office at Beijing Chest Hospital, Capital Medical University. He stated that, as medical researchers in the new era, striving to overcome critical bottlenecks in the pharmaceutical field and accelerating the translation of scientific achievements hold significant importance for exploring innovation-driven pathways to high-quality development.
Investigators are the principal entities in clinical trials, bearing responsibility for trial quality and the safety and rights of subjects, and they are key to determining the success or failure of clinical trials. In the context of China’s healthcare system, medical professionals participating in clinical trials already shoulder heavy clinical workloads, often leaving them with no choice but to serve as “part-time investigators.”
“The lack of dedicated clinical research personnel and insufficient awareness of Good Clinical Practice (GCP) are the primary obstacles affecting the efficiency and quality of current clinical trials,” pointed out Gao Jingtao. The entire process, lifecycle, and every stage of clinical trials are subject to stringent regulatory oversight. The multitude of details, complex rules, large number of participants, and intricate coordination processes require investigators and their teams to devote substantial energy and continuously explore and refine their clinical trial capabilities through practice, thereby imposing very high demands on investigators. However, the prevailing reality is that principal investigators (PIs) often lack the time to conduct clinical trials properly—a long-standing issue whose root cause lies in the absence of dedicated clinical trial researchers. This situation also hinders the steady improvement of researchers’ professional competencies in clinical trials, preventing them from concentrating their efforts on deepening expertise within specific research fields.
In addition, investigators’ insufficient awareness of Good Clinical Practice (GCP) and the arbitrary nature of clinical trial operations are also key factors affecting study quality. “Physicians who have conducted clinical trials in a standardized manner differ fundamentally from those who have not, in terms of logical reasoning, practical execution, and their attitude toward medical standards. We have observed numerous issues exposed by investigators during the conduct of clinical trials,” introduced Gao Jingtao, which manifest in two aspects:
First, standards are not strictly enforced, leading to arbitrary practices. “Although they have undergone GCP training and can recite the clauses proficiently, they fail to adhere to them in practice. It is not a matter of lacking understanding or competence, but rather a perception that strict compliance is unnecessary, as rigorous adherence makes implementation significantly more difficult,” introduced Gao Jingtao. Such cases of “knowing violation” are relatively common in multicenter clinical trials. For instance, follow-up visits and therapeutic interventions may not be conducted at the prescribed time points due to participant non-compliance or investigators being occupied with other matters. This arbitrariness in operational procedures may jeopardize the viability of the entire study.
Second, insufficient practical experience has led to numerous protocol deviations during implementation, including serious violations. For instance, failure to strictly verify eligibility criteria item by item has resulted in the erroneous or inappropriate enrollment of subjects. Additionally, varying interpretations of the term “baseline” among investigators during baseline data collection have compromised consistency in protocol execution. Such deviations are strictly prohibited in Phase I–III clinical trials, as they can severely undermine the integrity of study results.
Gao Jingtao believes that the shortage and insufficient capabilities of dedicated clinical trial personnel in hospitals will be difficult to improve in the short term. Given that clinical research is currently driven by investigators’ self-motivation and dedication, priority should be given to capacity building, including training in Good Clinical Practice (GCP), Good Clinical Laboratory Practice (GCLP), data management, and laboratory operations. In particular, one or two project coordinators within the hospital should be cultivated. By engaging clinical service outsourcing companies and leveraging the professional expertise of Contract Research Organizations (CROs) and data platform companies, a collaborative effort can be made to enhance clinical trial capabilities, thereby further improving the efficiency and quality of clinical research.
Clinical trials involve numerous stakeholders, ranging from investigators to clinical research associates (CRAs), project managers (PMs), quality assurance (QA) personnel, clinical research coordinators (CRCs), and sponsors. Consequently, the volume of information is substantial, and the informational nodes are intricate. However, different stakeholders often prioritize their own processes and standards, failing to adequately emphasize or streamline cross-functional coordination and handoff procedures, or lacking synchronized allocation of responsibilities. This leads to “no-man’s-land” gaps in the overall information chain, resulting in information silos or data distortion. Ultimately, this reduces the execution efficiency of clinical trials, renders quality uncontrollable, and increases risk factors. The high cost of clinical trials does not stem from absolute technical difficulty, but rather from the enormous human, material, and financial resources required to ensure long-term, stable, and high-quality collaboration among various roles and stakeholders across the industry.
Gao Jingtao, who has hands-on experience managing clinical trials from both the sponsor and hospital sides, describes the initiation of a clinical trial as “an overwhelming influx of countless documents.”
Initiating a clinical trial requires completing numerous preparatory tasks, such as institutional project approval, ethical review approval, and applications to the Human Genetic Resources Administration of China (HGRAC). This process involves the design and preparation of countless documents, including management plans and quality control plans, leading to repetitive and high communication costs. Specifically, the project approval stage alone entails numerous procedures, with some hospitals conducting approvals only once every two months or even once a year. The difficulty in initiating trials has become a major “stumbling block” to the rapid advancement of new drug clinical trials. According to the latest data from the Center for Drug Evaluation’s (CDE) Annual Report on the Progress of Clinical Trials for New Drug Registration in China (2021), the average time required to initiate a clinical trial is 12.2 months, indicating low implementation efficiency.
Gao Jingtao stated that improving the implementation efficiency of clinical trials after approval requires efforts on three levels: process, professionalism, and intelligence. 1) At the clinical execution level, promote process optimization. Since different stages and personnel involved in clinical trials often focus only on their own needs and principles, attention should be paid to overlapping areas or management gaps during protocol design. 2) The number of hospital staff participating in clinical trials and their available energy are limited; therefore, a strong professional external support team is needed. Based on frequent and professional communication, this can achieve twice the result with half the effort. 3) Enable data to be online, thereby allowing sponsors, investigators, and subjects to collaborate in real time and online.
“As digital technology plays an increasingly vital role across various sectors of the socio-economy, AI and digital technologies have become the key to ‘breaking the deadlock’ in the transformation of the clinical research industry, with clinical trials gradually evolving from digitization to digital intelligence,” said Gao Jingtao. He noted that digitally intelligent clinical trials will bring about two major changes: first, automation, where data management shifts from manual transcription to automated and intelligent processes, heralding lower error rates and higher efficiency; second, remote online operations, where offline communication transitions primarily to online collaboration, significantly reducing management and communication costs.
Digital intelligence can maximize the efficiency of clinical trials during the patient screening phase. Gao Jingtao introduced that patient recruitment and enrollment are the most uncertain and time-consuming aspects of clinical trials. The traditional approach involves passively waiting for subjects to “come forward” or relying on influential Principal Investigators (PIs) to mobilize recommendations from more departments and hospitals. This “wait-and-see” style of patient screening has affected 70% of clinical trials due to enrollment issues, causing many large pharmaceutical companies to fail in recruiting suitable subjects on schedule. This results in prolonged R&D cycles for clinical trials, delayed deliverables, and even trial termination.
“By leveraging the internet, big data, and artificial intelligence algorithms, we can assign multiple tags to each patient for intelligent screening,” said Gao Jingtao. Intelligent tagging enables a shift from a “one-size-fits-all” approach—where patients are identified solely by a single disease label—to a “multi-dimensional profile per individual,” significantly improving screening efficiency. This is particularly valuable as a cost-effective and efficiency-enhancing solution for multi-center, large-sample clinical trials.
Over the past decade, China’s clinical trial sector has experienced rapid development, evolving from nonexistence to prevalence, and from a state of initial unfamiliarity with the concept of clinical trials to securing a significant position on the global stage. China has now become the largest clinical trial hub in Asia. Despite the broad market prospects, the industry has endured its darkest hours, particularly in the field of infectious diseases, where new drug development has progressed slowly and clinical trials started relatively late.
Gao Jingtao and his team, dedicated to clinical research on tuberculosis, have endured the hardships and challenges inherent in anti-tuberculosis drug trials. Pulmonary tuberculosis, particularly drug-resistant TB, represents a major global public health challenge; excluding COVID-19, it remains the leading cause of death among single infectious diseases. The development of new drugs and vaccines has been significantly hindered by the elusive nature of Mycobacterium tuberculosis and its complex immune interactions with the host. It was not until 2017 that clinical trials for anti-tuberculosis drugs in China entered a period of robust growth.
Gao Jingtao explained, “In the past, we could only learn about new evidence from clinical trials of novel anti-tuberculosis drugs and regimens in regions such as South Africa and Europe through literature, without being able to participate. Gao Jingtao and his team have been committed to strengthening international cooperation and undertaking international clinical trials of anti-tuberculosis drugs as a key objective, striving to become an indispensable force in global infectious disease research, sharing Chinese expertise with the world, and contributing to achieving the goal of ending tuberculosis by 2035.”
Gao Jingtao further emphasized that, at the current stage and for a considerable period to come, clinical trials will remain predominantly centralized, as hospitals and principal investigators (PIs) with prestigious reputations serve as guarantees of research quality. From this perspective, research teams must first solidify their foundational competencies. She noted that Beijing Chest Hospital, as a national leader in the field of tuberculosis, has been committed to building and enhancing the capacity of China’s clinical trial research network for tuberculosis. In 2013, Beijing Chest Hospital spearheaded the establishment of the “China Tuberculosis Clinical Trial Consortium (CTCTC),” with the mission of “integrating Chinese resources to support and organize high-quality clinical research in tuberculosis treatment, diagnosis, and vaccines, thereby providing evidence-based support for tuberculosis diagnosis and treatment in China and worldwide.” The consortium works closely with the U.S. National Institutes of Health (NIH) and FHI 360 to strive for a tuberculosis clinical trial platform aligned with international standards. It has conducted a series of site assessments, basic training, and capacity-building activities, currently encompassing 28 designated tuberculosis hospitals across China that hold Good Clinical Practice (GCP) qualifications for new tuberculosis drug clinical trials. In 2019, it was designated by the Beijing Municipal Science & Technology Commission as the “Beijing International Science and Technology Cooperation Base for Clinical Tuberculosis Research.” The hospital has organized a series of capacity-building activities for clinical trials and simultaneously established the nation’s first “Intelligent Integrated Platform for Clinical Tuberculosis Research.”
Strengthening internal capabilities and enhancing institutional capacity to amplify the “halo effect” of hospitals and research teams is a prerequisite for achieving long-term, in-depth collaboration between hospitals and pharmaceutical companies. In turn, strong hospital–enterprise partnerships can provide more numerous and effective solutions to accelerate the translation of clinical research and promote the healthy development of the clinical research ecosystem.