Questionnaire survey and analysis of drug clinical research implementation capabilities of breast cancer treatment departments in Chinese hospitals
Introduction Breast cancer is currently the leading cause of malignant tumors worldwide . In China, the incidence and mortality rates of breast cancer rank first and fourth, respectively, among female malignant tumors . In recent years, the five-year survival rate of patients with breast cancer has increased substantially , mainly due to the promotion of early cancer screening and diagnosis, as well as the application of many new antitumor drugs, such as cyclin-dependent kinase 4/6 inhibitors (CDK4/6is) and antibody‒drug conjugates (ADCs), which have benefited from the rapid development of clinical research . From 2009 to 2018, 1493 cancer drug trials were initiated in China, and the annual number of initiated clinical trials increased over time, with an average annual growth rate of 33 % . These growth trends illustrate the increasing capability of cancer drug research and development achieved in mainland China over the decade since 2009. Moreover, the annual participation rate in clinical trials for new antitumor drugs in China has also increased substantially, with a 15.7 % average annual increase from 2011 to 2021 . China's self-developed drugs have been on the market continuously in recent years . In the field of breast cancer, many new drugs have been tested in clinical trials by international pharmaceutical companies , and several new drugs, including pyrotinib  and dalpiciclib , have been independently developed by China. Statistically, breast cancer ranks fourth in the number of registered trials of all cancer types, after solid tumors, non-small cell lung cancer (NSCLC) and lymphoma, accounting for 9 % of the total . Taken together, these findings indicate that breast cancer drug research and development play important roles in the field of new drug creation and production. However, there is still a gap in China's ability to participate in new drug research compared to that of European and American countries. Among the investigational new drug (IND) trials, the country with the highest participation rate among all the trials was the United States, which participated in 65.7 % of all the registered new drug trials . However, China ranks fifth, with participation in only 8.8 %. New drugs were marketed later in China than in foreign countries . In addition, from 2009 to 2018, 123 clinical trial units were involved as the leading site for cancer drug trials in mainland China, and the largest numbers of leading units were located in east China, followed by north China, whereas the smallest numbers were in northwest China and southwest China . Uneven regional distributions still persist. Moreover, the lack of simplicity in the processes related to preparation for clinical research implementation remains unresolved . Thus, it is vital to fully understand the current status of the capability of clinical research on breast cancer drugs in China to further improve its development. Nevertheless, most of the related studies and statistics have focused primarily on the quantity and characteristics of clinical research projects in China. Little is known about the capacity of clinical research implementation in breast cancer treatment departments, and thus, it is urgently important to launch appropriate studies to understand the current situation. Our study aimed to provide an overview of the status of clinical research implementation in breast cancer treatment departments in China, analyze the differences in the clinical research capacity of breast cancer departments in different regions and hospital classifications and identify the problems and challenges faced by current development, hoping to provide future directions for improving the clinical research capacity of breast cancer in China.   Material and methods 2.1 Data collection This was a department-based cross-sectional study conducted in the form of electronic questionnaires in China from 7th August to 31 st August 2023. This study was initiated by the breast cancer expert committee of the National Cancer Center (NCC). The questionnaire was designed on the Wenjuanxing platform. Our study was conducted among the first batch of breast cancer standardized diagnosis and treatment quality control pilot centers, which includes 200 hospitals selected by the NCC on the basis of the level of breast cancer diagnosis and treatment, surgery volume and other factors. Pilot hospitals included need to have at least 2 years of working experience in breast cancer diagnosis and treatment, with a number of 10 or more beds for breast cancer treatment, and a volume of more than 200 breast cancer surgeries per year. Besides, complete set-up of pathology, radiographic, radiotherapy and other ancillary departments are necessary. The centers cover 30 provinces (autonomous regions and municipalities), and all of them are tertiary-level general hospitals or cancer hospitals. These hospitals are good representatives of the provincial-level and prefectural-municipal-level hospitals engaged in the treatment of breast cancer in China. The departments included were required to be clinical departments conducting drug clinical research. 2.2 Group variance analysis The provinces are divided into east, central, west and northeast regions according to the four main geographic regions defined by the National Bureau of Statistics. General hospitals and specialized cancer hospitals were divided according to the clinical range. The departments were classified as departments of medical oncology and surgical oncology, as well as other departments, including departments of radiotherapy and breast cancer treatment centers. Comparative analysis of different departments was only conducted between departments of medical oncology and surgical oncology. 2.3 Questionnaire design and completion The authors designed the questionnaire based on the specific steps, current realities and potential difficulties in clinical research conduction in China. The questionnaire was completed by the head or secretary of the department. Duplicate questionnaires were not allowed for the same account. The questionnaire covered six aspects, namely, clinical research team-building, patient service and management, ethics operation, clinical research process implementation efficiency, clinical research participation and implementation experience, and the needs and problems encountered during clinical research implementation. The questions were mainly multiple choices and included one open-ended question. 2.4 Statistical analysis The capability and demands of clinical research implementation of breast cancer treatment departments were based on the descriptions of the questionnaire results. If more than one questionnaire was received from the same department at the same hospital, the optimal option was chosen according to the actual clinical performance estimated by experts. As ethics operations are usually hospital-based, ethics operations and clinical research process implementation efficiency were described and analyzed from 122 hospitals. The remaining questions, which mainly depended on departmental conditions, were analyzed from 127 departments. Subgroup difference analysis was performed using the chi-square test and Fisher's exact test. All p values were derived from two-sided tests, and the results were considered statistically significant at a p < 0.05. The open-ended question was described in the researcher's summary. The data were analyzed with SPSS for Windows, version 26.0 (SPSS Inc).   Data collection This was a department-based cross-sectional study conducted in the form of electronic questionnaires in China from 7th August to 31 st August 2023. This study was initiated by the breast cancer expert committee of the National Cancer Center (NCC). The questionnaire was designed on the Wenjuanxing platform. Our study was conducted among the first batch of breast cancer standardized diagnosis and treatment quality control pilot centers, which includes 200 hospitals selected by the NCC on the basis of the level of breast cancer diagnosis and treatment, surgery volume and other factors. Pilot hospitals included need to have at least 2 years of working experience in breast cancer diagnosis and treatment, with a number of 10 or more beds for breast cancer treatment, and a volume of more than 200 breast cancer surgeries per year. Besides, complete set-up of pathology, radiographic, radiotherapy and other ancillary departments are necessary. The centers cover 30 provinces (autonomous regions and municipalities), and all of them are tertiary-level general hospitals or cancer hospitals. These hospitals are good representatives of the provincial-level and prefectural-municipal-level hospitals engaged in the treatment of breast cancer in China. The departments included were required to be clinical departments conducting drug clinical research.   Group variance analysis The provinces are divided into east, central, west and northeast regions according to the four main geographic regions defined by the National Bureau of Statistics. General hospitals and specialized cancer hospitals were divided according to the clinical range. The departments were classified as departments of medical oncology and surgical oncology, as well as other departments, including departments of radiotherapy and breast cancer treatment centers. Comparative analysis of different departments was only conducted between departments of medical oncology and surgical oncology.   Questionnaire design and completion The authors designed the questionnaire based on the specific steps, current realities and potential difficulties in clinical research conduction in China. The questionnaire was completed by the head or secretary of the department. Duplicate questionnaires were not allowed for the same account. The questionnaire covered six aspects, namely, clinical research team-building, patient service and management, ethics operation, clinical research process implementation efficiency, clinical research participation and implementation experience, and the needs and problems encountered during clinical research implementation. The questions were mainly multiple choices and included one open-ended question.   Statistical analysis The capability and demands of clinical research implementation of breast cancer treatment departments were based on the descriptions of the questionnaire results. If more than one questionnaire was received from the same department at the same hospital, the optimal option was chosen according to the actual clinical performance estimated by experts. As ethics operations are usually hospital-based, ethics operations and clinical research process implementation efficiency were described and analyzed from 122 hospitals. The remaining questions, which mainly depended on departmental conditions, were analyzed from 127 departments. Subgroup difference analysis was performed using the chi-square test and Fisher's exact test. All p values were derived from two-sided tests, and the results were considered statistically significant at a p < 0.05. The open-ended question was described in the researcher's summary. The data were analyzed with SPSS for Windows, version 26.0 (SPSS Inc).   Results 3.1 Survey characteristics Questionnaires were distributed among 200 hospitals, 122 of which ultimately participated, for a response rate of 61 %. A total of 153 questionnaires were collected as of 31 August 2023, 22 of which were duplicated in the same department at the same hospital and 4 of which were completed by nonclinical department (Department of Pathology, Quality Control Department, Functional Department and Department of Interventional and Ultrasound Medicine). A total of 127 questionnaires were ultimately included in the analysis, and all the questionnaires met the inclusion criteria. Among all participating hospitals, 21 (17.2 %) were specialized cancer hospitals, and 101 (82.8 %) were general hospitals. Departments of surgical oncology accounted for 79.5 % (101/127), departments of medical oncology accounted for 15.0 % (19/127), and the remaining 5.5 % (7/127) were other departments (2 radiotherapy departments and 5 breast cancer treatment centers). Participating hospitals were distributed in 27 provinces, autonomous regions, and municipalities directly under the central government, with the largest number of hospitals and departments located in east China [48 (39.49 %)]. The geographical distribution of all the hospitals is shown in . 3.2 Drug clinical research implementation capacities of breast cancer treatment departments Our questionnaire was based on an objective questionnaire survey of the level of competence involved in implementing clinical drug research and solicited the needs of each department through both objective and open-ended questions. The specific detailed questionnaire used is shown in . 3.2.1 Clinical research team-building capabilities As shown in , in terms of professional staffing for clinical research, 95 (74.8 %) departments had more than 5 medical personnel with IND trials participation experience. Medical personnel involved in the clinical research of 118 (92.9 %) departments had received good clinical practice (GCP) training. A total of 98 (77.2 %) departments had more than 5 medical personnel with GCP certificates. Ninety-two (72.4 %) departments had clinical research nurse specialists. 120 (94.5 %) departments carried out more than one internal professional communication and training activity per month. 3.2.2 Patient service and management capabilities All departments carried out patient education activities each month, mostly 1–2 times per month, accounting for 73.2 % (93/127). A total of 118 (92.9 %) departments carried out regular out-of-hospital patient follow-up visits. In terms of the electronic platform application, 79 (62.2 %) departments had established specialized disease databases, and 85 (66.9 %) departments were able to use patient follow-up electronic platforms. The details are shown in . 3.2.3 Ethics operation capability In terms of the development of the ethics review process from a hospital perspective, 89.3 % (109/122) had undergone centralized institutional review board (IRB) review, 77.9 % (95/122) carried out ethics previews, and approximately half of the hospitals participated in regional ethics mutual recognition, accounting for 58.2 % (71/122). Regarding the efficiency of ethics review, the dates of ethics meetings of 47.5 % (58/122) of the hospitals were irregular, and the remaining hospitals were able to hold monthly ethics meetings, mostly once per month, accounting for 40.2 % (49/122). A total of 79.5 % (97/122) of the hospitals held expedited ethics meetings according to demand. In addition, 76.2 % (93/122) of the hospitals had designated staff in charge of ethics document reception and the ethics process interface. The details are shown in . 3.2.4 Situation of clinical research process implementation efficiency More than half of the hospitals [57.4 % (70/122)] took an average of 2–4 weeks from the submission of project review documents to project approval. A total of 57.4 % (70/122) of the hospitals took an average of 2–4 weeks for the project contract signature, and less than one-third of the hospitals [22.1 % (27/122)] took 1 week or less for this process. After the ethics meeting, 43.4 % (53/122) of the hospitals took 2–4 weeks to obtain ethics approval. The average time taken to sign documents about the management of human genetics resources was approximately 2–4 weeks in 56.6 % (69/122) of the hospitals. At the research completion stage, more than half of the hospitals [62.3 % (76/122)] spent 2–4 weeks from the time they submitted a completion request until they finally completed the process. The details are shown in . 3.2.5 Clinical research participation and implementation experience The majority of departments had initiated 2 or fewer IND trials (72.4 %) or investigator-initiated trials (IITs) (80.3 %) in the past year. The number of departments participating in clinical trials was slightly greater than that involved in initiation. In terms of patient enrollment, the majority of departments (70.1 %) had enrolled 50 or fewer patients in breast cancer-related IND trials in the past year, and only 7.1 % had enrolled 200 or more patients. Overall, 72.4 % of the hospitals had a patient dropout rate of less than 5 % in the past year. In terms of clinical trial audits, approximately half of the departments (47.2 %) had received 1–2 audits in the past year. The details are shown in . 3.3 Differences in clinical research implementation among regions, departments and hospital classifications To further analyze the differences in clinical research implementation capabilities, we conducted comparisons among different regions, departments, and hospital types. The central region had the largest number of departments with patient follow-up platform applications, and the western region had the smallest number (northeast vs. east vs. west vs. central: 84.6 % vs. 64.0 % vs. 51.4 % vs. 85.2 %, p = 0.017). The frequency of ethics meetings in the northeast region was relatively regular, with 75 % of the hospitals conducted more than once ethics meetings per month. However, more than half of the hospitals in the west and central regions had irregular frequencies of ethics meetings. A total of 38.5 % of departments in the northeast region enrolled more than 200 patients in breast cancer IND trials, which was the highest among all regions . For the differences between different departments, 120 questionnaires from department of medical and surgical oncology were included. all medical oncology staff had more than 5 personnel with GCP certificates (0, 1–5 people, more than 5 people had GCP certificates in medical oncology vs. surgical oncology: 0 %, 0 %, 100 % vs. 3.0 %, 24.7 %, 72.3 %, p = 0.018). In addition, departments of medical oncology processed a greater number of initiated and participated clinical studies than surgical oncology departments . Among the different hospital classifications, ethics meetings were held more frequently and steadily in specialized cancer hospitals than in general hospitals (not fixed, once/month, more than 2 times/month at specialized cancer hospitals vs. general hospitals: 23.8 %, 42.9 %, 33.3 % vs. 52.5 %, 39.6 %, 7.9 %). More specialized cancer hospitals initiated and participated in IITs and IND trials than general hospitals. There were far more patients enrolled in RCTs in specialized cancer hospitals than in general hospitals (within 50, 50–200, or more than 200 patients in specialized cancer hospitals vs. general hospitals: 39.1 %, 52.2 %, and 8.7 % vs. 76.9 %, 16.4 %, and 6.7 %, respectively; p = 0.001) . 3.4 Difficulties and demands of the implementation of clinical trials We also investigated the needs and difficulties encountered by departments during the implementation of clinical research. Most of the departments were strongly willing to undertake clinical research (98.4 %), and there was a demand for clinical research on different types of drugs, including small molecular targeted drugs (97.6 %), biological products (91.3 %) and cytotoxic drugs (72.4 %). Among the problems encountered in the initiation of clinical research, the most difficult were limitations in the quality and quantity of the projects, a lack of funding, and inefficiency in research execution and implementation, which accounted for 60.6 %, 55.9 %, and 47.2 %, respectively. In the process of conducting the study, the most common problem was patient recruitment, accounting for 79.5 %. According to the difference analysis, general hospitals encountered more limitations in terms of the quality and quantity of clinical research projects. The main needs were focused on trial recommendation and leading, which accounted for 83.5 %, followed by professional guidance for team personnel, which accounted for 78.7 %. The details are shown in and . To gain a broader understanding of the actual needs, we designed an open-ended question to reflect the subjective ideas and suggestions of each department in the development of clinical research. Since there was no fixed answer format, the main needs of each department were summarized as follows: First, the NCC was expected to establish a national clinical research recruitment and data sharing platform to improve clinical research recruitment and regional participation among breast cancer departments. Second, the frequency of professional training for regional breast cancer departments urgently needs to increase. Third, funding support and targeted assistance need to be offered and supported by substantive policies.   Survey characteristics Questionnaires were distributed among 200 hospitals, 122 of which ultimately participated, for a response rate of 61 %. A total of 153 questionnaires were collected as of 31 August 2023, 22 of which were duplicated in the same department at the same hospital and 4 of which were completed by nonclinical department (Department of Pathology, Quality Control Department, Functional Department and Department of Interventional and Ultrasound Medicine). A total of 127 questionnaires were ultimately included in the analysis, and all the questionnaires met the inclusion criteria. Among all participating hospitals, 21 (17.2 %) were specialized cancer hospitals, and 101 (82.8 %) were general hospitals. Departments of surgical oncology accounted for 79.5 % (101/127), departments of medical oncology accounted for 15.0 % (19/127), and the remaining 5.5 % (7/127) were other departments (2 radiotherapy departments and 5 breast cancer treatment centers). Participating hospitals were distributed in 27 provinces, autonomous regions, and municipalities directly under the central government, with the largest number of hospitals and departments located in east China [48 (39.49 %)]. The geographical distribution of all the hospitals is shown in .   Drug clinical research implementation capacities of breast cancer treatment departments Our questionnaire was based on an objective questionnaire survey of the level of competence involved in implementing clinical drug research and solicited the needs of each department through both objective and open-ended questions. The specific detailed questionnaire used is shown in . 3.2.1 Clinical research team-building capabilities As shown in , in terms of professional staffing for clinical research, 95 (74.8 %) departments had more than 5 medical personnel with IND trials participation experience. Medical personnel involved in the clinical research of 118 (92.9 %) departments had received good clinical practice (GCP) training. A total of 98 (77.2 %) departments had more than 5 medical personnel with GCP certificates. Ninety-two (72.4 %) departments had clinical research nurse specialists. 120 (94.5 %) departments carried out more than one internal professional communication and training activity per month. 3.2.2 Patient service and management capabilities All departments carried out patient education activities each month, mostly 1–2 times per month, accounting for 73.2 % (93/127). A total of 118 (92.9 %) departments carried out regular out-of-hospital patient follow-up visits. In terms of the electronic platform application, 79 (62.2 %) departments had established specialized disease databases, and 85 (66.9 %) departments were able to use patient follow-up electronic platforms. The details are shown in . 3.2.3 Ethics operation capability In terms of the development of the ethics review process from a hospital perspective, 89.3 % (109/122) had undergone centralized institutional review board (IRB) review, 77.9 % (95/122) carried out ethics previews, and approximately half of the hospitals participated in regional ethics mutual recognition, accounting for 58.2 % (71/122). Regarding the efficiency of ethics review, the dates of ethics meetings of 47.5 % (58/122) of the hospitals were irregular, and the remaining hospitals were able to hold monthly ethics meetings, mostly once per month, accounting for 40.2 % (49/122). A total of 79.5 % (97/122) of the hospitals held expedited ethics meetings according to demand. In addition, 76.2 % (93/122) of the hospitals had designated staff in charge of ethics document reception and the ethics process interface. The details are shown in . 3.2.4 Situation of clinical research process implementation efficiency More than half of the hospitals [57.4 % (70/122)] took an average of 2–4 weeks from the submission of project review documents to project approval. A total of 57.4 % (70/122) of the hospitals took an average of 2–4 weeks for the project contract signature, and less than one-third of the hospitals [22.1 % (27/122)] took 1 week or less for this process. After the ethics meeting, 43.4 % (53/122) of the hospitals took 2–4 weeks to obtain ethics approval. The average time taken to sign documents about the management of human genetics resources was approximately 2–4 weeks in 56.6 % (69/122) of the hospitals. At the research completion stage, more than half of the hospitals [62.3 % (76/122)] spent 2–4 weeks from the time they submitted a completion request until they finally completed the process. The details are shown in . 3.2.5 Clinical research participation and implementation experience The majority of departments had initiated 2 or fewer IND trials (72.4 %) or investigator-initiated trials (IITs) (80.3 %) in the past year. The number of departments participating in clinical trials was slightly greater than that involved in initiation. In terms of patient enrollment, the majority of departments (70.1 %) had enrolled 50 or fewer patients in breast cancer-related IND trials in the past year, and only 7.1 % had enrolled 200 or more patients. Overall, 72.4 % of the hospitals had a patient dropout rate of less than 5 % in the past year. In terms of clinical trial audits, approximately half of the departments (47.2 %) had received 1–2 audits in the past year. The details are shown in .   Clinical research team-building capabilities As shown in , in terms of professional staffing for clinical research, 95 (74.8 %) departments had more than 5 medical personnel with IND trials participation experience. Medical personnel involved in the clinical research of 118 (92.9 %) departments had received good clinical practice (GCP) training. A total of 98 (77.2 %) departments had more than 5 medical personnel with GCP certificates. Ninety-two (72.4 %) departments had clinical research nurse specialists. 120 (94.5 %) departments carried out more than one internal professional communication and training activity per month.   Patient service and management capabilities All departments carried out patient education activities each month, mostly 1–2 times per month, accounting for 73.2 % (93/127). A total of 118 (92.9 %) departments carried out regular out-of-hospital patient follow-up visits. In terms of the electronic platform application, 79 (62.2 %) departments had established specialized disease databases, and 85 (66.9 %) departments were able to use patient follow-up electronic platforms. The details are shown in .   Ethics operation capability In terms of the development of the ethics review process from a hospital perspective, 89.3 % (109/122) had undergone centralized institutional review board (IRB) review, 77.9 % (95/122) carried out ethics previews, and approximately half of the hospitals participated in regional ethics mutual recognition, accounting for 58.2 % (71/122). Regarding the efficiency of ethics review, the dates of ethics meetings of 47.5 % (58/122) of the hospitals were irregular, and the remaining hospitals were able to hold monthly ethics meetings, mostly once per month, accounting for 40.2 % (49/122). A total of 79.5 % (97/122) of the hospitals held expedited ethics meetings according to demand. In addition, 76.2 % (93/122) of the hospitals had designated staff in charge of ethics document reception and the ethics process interface. The details are shown in .   Situation of clinical research process implementation efficiency More than half of the hospitals [57.4 % (70/122)] took an average of 2–4 weeks from the submission of project review documents to project approval. A total of 57.4 % (70/122) of the hospitals took an average of 2–4 weeks for the project contract signature, and less than one-third of the hospitals [22.1 % (27/122)] took 1 week or less for this process. After the ethics meeting, 43.4 % (53/122) of the hospitals took 2–4 weeks to obtain ethics approval. The average time taken to sign documents about the management of human genetics resources was approximately 2–4 weeks in 56.6 % (69/122) of the hospitals. At the research completion stage, more than half of the hospitals [62.3 % (76/122)] spent 2–4 weeks from the time they submitted a completion request until they finally completed the process. The details are shown in .   Clinical research participation and implementation experience The majority of departments had initiated 2 or fewer IND trials (72.4 %) or investigator-initiated trials (IITs) (80.3 %) in the past year. The number of departments participating in clinical trials was slightly greater than that involved in initiation. In terms of patient enrollment, the majority of departments (70.1 %) had enrolled 50 or fewer patients in breast cancer-related IND trials in the past year, and only 7.1 % had enrolled 200 or more patients. Overall, 72.4 % of the hospitals had a patient dropout rate of less than 5 % in the past year. In terms of clinical trial audits, approximately half of the departments (47.2 %) had received 1–2 audits in the past year. The details are shown in .   Differences in clinical research implementation among regions, departments and hospital classifications To further analyze the differences in clinical research implementation capabilities, we conducted comparisons among different regions, departments, and hospital types. The central region had the largest number of departments with patient follow-up platform applications, and the western region had the smallest number (northeast vs. east vs. west vs. central: 84.6 % vs. 64.0 % vs. 51.4 % vs. 85.2 %, p = 0.017). The frequency of ethics meetings in the northeast region was relatively regular, with 75 % of the hospitals conducted more than once ethics meetings per month. However, more than half of the hospitals in the west and central regions had irregular frequencies of ethics meetings. A total of 38.5 % of departments in the northeast region enrolled more than 200 patients in breast cancer IND trials, which was the highest among all regions . For the differences between different departments, 120 questionnaires from department of medical and surgical oncology were included. all medical oncology staff had more than 5 personnel with GCP certificates (0, 1–5 people, more than 5 people had GCP certificates in medical oncology vs. surgical oncology: 0 %, 0 %, 100 % vs. 3.0 %, 24.7 %, 72.3 %, p = 0.018). In addition, departments of medical oncology processed a greater number of initiated and participated clinical studies than surgical oncology departments . Among the different hospital classifications, ethics meetings were held more frequently and steadily in specialized cancer hospitals than in general hospitals (not fixed, once/month, more than 2 times/month at specialized cancer hospitals vs. general hospitals: 23.8 %, 42.9 %, 33.3 % vs. 52.5 %, 39.6 %, 7.9 %). More specialized cancer hospitals initiated and participated in IITs and IND trials than general hospitals. There were far more patients enrolled in RCTs in specialized cancer hospitals than in general hospitals (within 50, 50–200, or more than 200 patients in specialized cancer hospitals vs. general hospitals: 39.1 %, 52.2 %, and 8.7 % vs. 76.9 %, 16.4 %, and 6.7 %, respectively; p = 0.001) .   Difficulties and demands of the implementation of clinical trials We also investigated the needs and difficulties encountered by departments during the implementation of clinical research. Most of the departments were strongly willing to undertake clinical research (98.4 %), and there was a demand for clinical research on different types of drugs, including small molecular targeted drugs (97.6 %), biological products (91.3 %) and cytotoxic drugs (72.4 %). Among the problems encountered in the initiation of clinical research, the most difficult were limitations in the quality and quantity of the projects, a lack of funding, and inefficiency in research execution and implementation, which accounted for 60.6 %, 55.9 %, and 47.2 %, respectively. In the process of conducting the study, the most common problem was patient recruitment, accounting for 79.5 %. According to the difference analysis, general hospitals encountered more limitations in terms of the quality and quantity of clinical research projects. The main needs were focused on trial recommendation and leading, which accounted for 83.5 %, followed by professional guidance for team personnel, which accounted for 78.7 %. The details are shown in and . To gain a broader understanding of the actual needs, we designed an open-ended question to reflect the subjective ideas and suggestions of each department in the development of clinical research. Since there was no fixed answer format, the main needs of each department were summarized as follows: First, the NCC was expected to establish a national clinical research recruitment and data sharing platform to improve clinical research recruitment and regional participation among breast cancer departments. Second, the frequency of professional training for regional breast cancer departments urgently needs to increase. Third, funding support and targeted assistance need to be offered and supported by substantive policies.   Discussion With the rapid development of clinical research and the continuous enhancement of innovation capabilities in China, the quality and implementation capability of clinical research have drawn widespread attention. Our study is one of the earliest known surveys focusing on the drug clinical research implementation capacities of breast cancer treatment departments in China. The involved hospitals basically covered the major provinces in mainland China. The questionnaire covered not only the current status of different departments in terms of team building, ethics procedures, and the conditions of previous research implementation experience but also the demands and main difficulties encountered at present and the differences among different geographical regions, departments and hospital classifications. We aimed to clarify the current status of clinical drug research in breast cancer treatment departments and provide targeted directions for future development. Our study reported that Chinese breast cancer treatment departments generally possess an appropriate level of competence in the implementation of drug clinical research, with a basically complete implementation process and, to a certain extent, joint participation from regional oncology treatment institutions. The medical oncology department presented greater research participation and initiation than the surgical oncology department. As our research was mainly focused on drug clinical research in breast cancer, it is not unexpected that departments of medical oncology have more experience than departments of surgical oncology in drug clinical research conduction due to the difference in their departmental functions. Moreover, specialized cancer hospitals are more experienced than general hospitals in conducting clinical research, which may be related to the characteristics of treatment at specialty hospitals. It is obvious that specialized cancer hospitals are more targeted in terms of patient population, which is more conducive to the inclusion of patients in clinical research. Besides, specialized cancer hospitals are equipped with more professional teams and auxiliary departments, which certainly means stronger multidisciplinary support. Professional training and communication as well as research recommendations and implementations are the most urgent needs for clinical research development. Clinical research has undergone rapid development in China in recent years. The annual number of initiated clinical trials, new drugs, and newly added leading clinical trial units sharply increased after 2016 . The number of new antitumor drugs approved is also increasing, and almost half of the cancer drug indications approved in China have improved overall survival . In addition, the annual number of drugs with clinically meaningful benefits from therapies approved in China according to the European Society for Medical Oncology-Magnitude of Clinical Benefit Scale (ESMO-MCBS) increased from 0 in 2005 to 6 in 2018 . All of China's early-phase clinical trials have also shown yearly growth; a total of 996 drugs were tested in phase 1 trials, and 1359 phase 1 trials of anticancer drugs were initiated in China from 2017 to 2021 . Analysis of the results of Food and Drug Administration (FDA) research in China and the United States from 2009 to July 2023 showed that the quality of clinical trials implemented in China has improved considerably annually, and clinical trials with no action indicated (NAI) have increased from 48 % to 85 %, suggesting that the results of such verification have been superior to those in the United States since 2016 . According to the clinical research implementation capability reflected in our findings, most department personnel have had experience in breast cancer clinical trial participation and have undergone standardized GCP training, indicating that the clinical research team was basically complete. Most departments are able to establish patient follow-up electronic platforms and carry out patient education and follow-up activities regularly. According to the needs section of our survey, most departments showed enthusiasm for actively participating in clinical research and a willingness to receive professional and standardized training. All of the above results showed that the quality and capability of clinical research implementation in China meet clinical requirements and have gained a certain degree of international recognition and industry competitiveness, which is inextricably linked to good conditions for conducting clinical research and a standardized clinical research system. Although the number of new drug approvals is increasing annually, Chinese research and development (R&D) of innovative antitumor drugs is still facing great challenges. Between 2005 and 2021, 66 % of drugs were developed by foreign companies . In addition to the basic research and clinical trial design capabilities that need to be further improved, the ability of clinical research to be implemented as the foundation and key part of the process of developing a new drug for clinical treatment is highly important. With the increase in interregional exchanges, disparities in clinical research due to geographical differences and uneven distributions of medical resources are gradually easing. However, in some aspects of clinical research, the west region is slightly less suitable than other regions. This may be related to differences in the distribution of healthcare resources due to overall national planning and persistent regional differences in economic levels. Improving the balance between equitable access to new drugs and the efficiency of pharmaceutical research and development is an important topic worthy of exploration by policy-makers. Moreover, overall and synchronous participation in registered cancer drug trials in China is much lower than that in the United States, European countries and Japan, especially for exploratory trials . This phenomenon is consistent with our research findings. In addition, our findings showed that the efficiency of drug clinical research implementation is equally severe, with most hospitals taking 2–4 weeks or more to complete part of the approval process and suffering an irregular frequency of ethics meetings. This condition imputes inconsistent review requirements, processes and forms as well as cumbersome processes. Moreover, the personnel of ethics committees are mostly part-time personnel, resulting in a mismatch between the ethical workload and staffing, which certainly increases the difficulty of ethics review implementation, indicating that the ethics approval process still needs to be further improved and simplified on the basis of ensuring strict review norms. Moreover, 58.02 % of the hospitals participated in regional ethics mutual recognition in our research, and the capacity for homogenization, such as regional ethics mutual recognition, still needs to be improved to circumvent the waste of resources and time involved in ethics review and further improve efficiency. All of the above conditions suggest that we still face many challenges in improving clinical research capacity. Our research reflects that more than half of the departments encountered limitations in the quality and quantity of their studies and a lack of project funding. Constant challenges have been encountered with respect to the development of quality control and management standards. In 2017, China formally proposed the implementation of register management for the qualification accreditation of clinical trial organizations. In recent years, the National Medical Products Administration (NMPA) has frequently issued various regulations, policies, documents and guiding principles and established the “ Measures for the supervision and inspection of drug clinical trials institution (for trial implementation) ” in Nov 2023 . Through the implementation of the clinical trial organization responsibility and principal investigator (PI) responsibility system, China has strengthened the sense of responsibility of all parties involved in clinical research, comprehensively promoted the training of full-time clinical researchers and the construction of professional teams, and further safeguarded the quality of clinical trials conducted. Moreover, this approach makes full use of China's national-level medical centers and regional-level medical centers and overall national planning settings to reasonably allocate high-quality medical research resources, promote the sharing of regional medical resources and conduct clinical research with regional characteristics. Moreover, it is beneficial to make full use of the role of electronic information dissemination and establish a national multicenter clinical trial registry and scientific research collaboration electronic platform to strengthen the communication of clinical research information and scientific achievement between the ethics committee of the leading unit and the participating institutions and to promote mutual recognition of ethics reviews and process simplification. There are some limitations in this study. First, although this study was initiated by the breast cancer expert committee of the NCC, it covered a limited number of hospitals, which were mainly provincial and prefectural medical centers. Few national and county-level oncology centers participated, and some representative hospitals were not involved in the questionnaire survey. Moreover, the sample sizes of the participating hospitals in different regions varied, and the participating departments were mainly surgical departments, which is due to the particular characteristics of breast cancer treatment. Thus, this difference may have weakened the results of difference analysis to a certain extent. Additionally, the questionnaires were completed by department leaders or secretaries, which basically reflects the real characteristics of the current status of clinical research, but there is unavoidable subjectivity. However, our questionnaire design did not involve precise numerical questions, and most of the questions were generalized options to avoid the lack of authenticity of the information provided by subjective completion. Finally, the questionnaire may not have comprehensively covered all the levels of clinical capabilities, and some of the possible problems and needs cannot have been truly reflected.   Conclusions This questionnaire survey provided insights into the current situation and improvement potential of the drug clinical research implementation quality of breast cancer treatment departments. Our study indicated that breast cancer treatment departments in China basically process complete drug clinical research implementation and meet the needs of rapid development and drug innovation. However, there is still room for improvement in terms of implementation efficiency, quality and quantity of research and patient recruitment. Uneven development and needs in some respects between different regions, departments and hospital classifications still exist. Most departments still require professional training and communication, as well as the recommendation and implementation of clinical research. The above findings are expected to lead future development directions for clinical research on breast cancer drugs in China.   This work was supported by the CAMS Innovation Fund for Medical Sciences ( CIFMS , Grant No. 2022-I2M-2-001 ).   Not applicable.   The data that support the findings of this study are available on request from the corresponding author.   Bo Lan: Writing – review & editing, Writing – original draft, Methodology. Xuenan Peng: Writing – original draft, Visualization, Methodology, Formal analysis. Fei Ma: Validation, Supervision, Funding acquisition, Conceptualization.   None.   