我国临床研究人才队伍建设现况与改进策略研究

摘要/Abstract

摘要：

目的·调研我国临床研究人才队伍建设现况与问题，并提出针对性改进策略。方法·通过文献查阅、专家访谈和2轮德尔菲法自制调查问卷，对来自27个省、市、自治区的医院、生物医药企业、医学院校、政府部门中熟悉临床研究的相关人员（583人）开展网络问卷调研，并对调研结果进行统计分析。结果·共计回收问卷583份，其中有效问卷579份，有效率为99.3%。调研结果显示：① 临床研究人才缺乏和人才发展环境不佳是制约我国高水平临床研究的关键因素。② 在被调查对象中，对当前临床研究人才培养不尽如人意（很不满意、不满意和一般）者占比72.7%。主要问题包括：高水平研究型人才的缺乏，同时缺乏一支专业支撑队伍；目前的绩效评价体系过于单一且薪酬、激励未向临床研究工作倾斜，从事临床研究的医务人员、临床研究支撑服务人才缺乏晋升渠道等。③ 改进策略包括：系统性提升医务人员临床研究能力，完善临床研究能力培训课程体系，在学校教育阶段和在职教育阶段采取不同的培养方式，在临床研究人才队伍的扩充上要注重临床研究型医师和临床研究方法学专门人才两支队伍的培养。结论·提升我国临床研究水平，急需扩大优秀医学生的培养数量，完善临床研究方法学、相关法规等课程；鼓励高水平研究型医师指导新人，在研究项目中做好传帮带；系统化提高在职医务人员的科研能力，做好临床研究项目的规范实施、选题设计等培训；凝聚一支高水平复合型临床研究医务人员队伍，加大临床研究方法学的专业人才培养力度；进一步重视临床研究，从职称晋升、薪酬待遇、科研评价等方面完善临床研究人才的发展环境。

关键词: 临床研究, 人才队伍建设, 现存问题, 改进策略

Abstract:

Objective ·To investigate the current situation and problems of the construction of clinical research talents team in China, and propose targeted improvement strategies. Methods ·Self-designed questionnaires were made after literature review, expert interviews and two rounds of Delphi. An online questionnaire survey was conducted on 583 clinical research-related personnel from hospitals, biomedical enterprises, medical colleges and government departments in 27 provinces, cities and autonomous regions, and the survey results were analyzed. Results ·A total of 583 questionnaires were collected, 579 of which were valid, with an effective rate of 99.3%. The research results showed that: ① The lack of clinical research talents and the poor development environment of talents were the key factors restricting the high-level clinical research in China. ② Among the respondents, 72.7% of them were dissatisfied (very dissatisfied, dissatisfied and average) with the current training of clinical research talents. The main problems included lack of high-level research talents and a professional support team; the current performance evaluation system was monotonous, the salary and incentive were not profitable for clinical research, and medical personnel engaged in clinical research and support staff lacked promotion channels, etc. ③ The improvement strategies included systematically improving the clinical research ability of medical personnel, improving the clinical research training curriculum system, adopting different training methods in the school education stage and in-service education stage, and attaching more importance to the two teams′ training, clinical research physicians and clinical research methodology professionals. Conclusion ·Currently, it is urgent to expand the number of excellent medical students and improve the courses of clinical research methodology and relevant laws and regulations, encourage experienced research-oriented doctors to guide new staff in research projects, systematically improve the scientific research ability of current medical personnel, pay more attention to training of standardized implementation of clinical research projects, topic selection design and others, gather a high-level team of composite clinical research medical personnel, increase the amount of professionals in clinical research methodology, further attach importance to clinical research, and improve the development environment of clinical research talents from the aspects of professional title promotion, salary, scientific research evaluation, etc, so as to improve the level of clinical research in China.

Key words: clinical research, talent team construction, existing problem, improvement strategy

中图分类号:

R197.322

李冬凉, 王甦平, 何豪, 王炳顺, 周良. 我国临床研究人才队伍建设现况与改进策略研究[J]. 上海交通大学学报（医学版）.

LI Dongliang, WANG Suping, HE Hao, WANG Bingshun, ZHOU Liang. Analysis on the existing problems and improving approaches to the clinical research talents team cultivation in China[J]. Journal of Shanghai Jiao Tong University (Medical Science).

图/表 10

表1 调查问卷的问题清单

Tab 1 Question list in questionnaire

Number	Main question
1	What do you think are the main factors restricting high-level clinical research in China?
2	Are you satisfied with the current situation of clinical research talent training in China?
3	What types of talents are the most lacking in the clinical research team at present?
4	What are the factors restricting the development of clinical research talents in China?
5	What are the clinical research capabilities that need to be improved for medical personnel?
6	What specialized courses are most needed to improve the clinical research ability of medical personnel?
7	To improve the clinical research ability of medical personnel, which training methods are more helpful?
8	What are the most necessary measures to fill the gap of clinical research methodology talents, clinical research project management specialists, clinical research coordinators and other professionals?

表2 调查对象的基本情况［n （%）］

Tab 2 Basic information of the respondents ［n （%）］

Item	Respondent (n=579)
Gender
Male	333 (57.5)
Female	246 (42.5)
Education ground
Doctor degree	114 (19.7)
Master degree	162 (28.0)
Bachelor degree	227 (39.2)
Undergraduate	76 (13.1)
Professional title
Senior	60 (10.4)
Deputy senior	76 (13.1)
Medium	165 (28.5)
Primary	220 (38.0)
Under primary	58 (10.0)
Work place
Hospital	246 (42.5)
Grade-A tertiary	187 (32.3)
Non grade-A tertiary	59 (10.2)
Enterprise	134 (23.1)
College and university	111 (19.2)
Government	47 (8.1)
Others	41 (7.1)
Occupation
Physician	183 (31.6)
Nurse	60 (10.4)
Teacher	86 (14.9)
Researcher	30 (5.2)
Administrator	37 (6.4)
Corporation personnel	137 (23.7)
Others	46 (7.9)

图1 制约我国高水平临床研究的影响因素的帕累托图Note： A. At present, the scientific research evaluation system has led to the establishment of research projects that focus on “less clinical than basic”. B. Generally, the clinical research cycle is too long, and clinical researchers are forced to choose short, easy and fast research topics as far as possible due to the requirements of professional titles, awards, etc. C. Clinical research involves a wide range of areas, lacking initiatives to share collaborative achievements, and build a collaborative research culture. D. Lack of high-level research talents and a professional support team. E. The number of clinical research wards is limited. F. Insufficient investment in clinical research and poor funding channel. G. Medical personnel are busy with their daily diagnosis and treatment, while some types of clinical researches, such as those initiated by researchers, take too much time and they cannot take care of both. H. Lack of channels to understand research frontiers and obtain other internal and external research experience, and limited research ideas. I. Others.

Fig 1 Pareto diagram of influential factors restricting high-level clinical research in China

表3 调查对象对我国临床研究人才培养现状的满意度评价

Tab 3 Satisfaction evaluation of respondents on the current clinical research talent cultivation in China

Satisfaction	Respondents (n=579)/n (%)	Hospital staff (n=246)/n (%)		Non-hospital staff (n=333)/n (%)
Satisfaction	Respondents (n=579)/n (%)	Grade-A tertiary hospital (n=187)	Non grade-A tertiary hospital (n=59)	Non-hospital staff (n=333)/n (%)
Very dissatisfied	77 (13.2)	14 (7.5)	4 (6.8)	59 (17.7)
Dissatisfied	137 (23.7)	27 (14.4)	17 (28.8)	93 (27.9)
Average	207 (35.8)	69 (36.9)	18 (30.5)	120 (36.0)
Satisfactory	142 (24.5)	69 (36.9)	19 (32.2)	54 (16.2)
Very satisfied	16 (2.8)	8 (4.3)	1 (1.7)	7 (2.1)

表4 调查对象对临床研究人才类型的缺乏程度的评价统计

Tab 4 Statistics of respondents′ evaluation on the lack of clinical research talent type

Lack of talent type	No.1/n	No.2/n	No.3/n	No.4/n	No.5/n	No.6/n	Ranking average score/score	Final ranking
Research physician	277	50	40	28	21	1	5.3	1
Clinical research methodology talent (such as statistician)	115	151	75	31	17	0	4.8	2
Full time scientific researcher	99	93	53	41	70	1	4.3	3
Research nurse	1	2	3	4	5	0	3.3	4
Project management coordinator	1	2	3	4	5	6	2.7	5
Others	1	2	0	4	5	6	2.4	6

图2 制约临床研究人才建设的影响因素的帕累托图Note： A. Managers have insufficient understanding of the importance of clinical research. B. There is a shortage of clinical research talents, and the current personnel are lack of clinical research ability. C. The current performance evaluation system is monotonous, meanwhile the salary and incentive are not profit able for clinical research. D. In the existing evaluation and employment system, there is no clinical research professional title, and medical personnel engaged in clinical research and support staff lack promotion channels. E. The lack of research culture of collaboration and sharing makes it difficult to form a strong clinical research cooperation team. F. Others.

Fig 2 Pareto diagram of influential factors restricting the construction of clinical research talents

图3 临床研究人员亟需提升的核心能力的帕累托图Note：A. Finding clinical problems and refining research direction. B. Clinical study design. C. Standardizing clinical research, including quality control and data collection. D. Statistical analysis and other clinical research methods. E. Knowing relevant laws and regulations. F. Communication, coordination, organization and management during project implementation. G. Others.

Fig 3 Pareto diagram of core competences that clinical researchers need to improve

图4 临床研究人员能力培训的课程体系建设的帕累托图Note： A. Core knowledge and new progress of clinical specialty (including theory and operation). B. Clinical research methodology course (including research design, epidemiology and statistics). C. Laws and regulations related to clinical research (such as ethical norms, regulatory policies, etc.). D. Advanced medical theories and technologies. E. Interpretation of actual cases in clinical research. F. Others.

Fig 4 Pareto diagram of curriculum system construction for competence training of clinical researchers

表5 临床研究人才培养方式的选择及统计

Tab 5 Selection and statistics of the training methods for clinical research talents

Item	Respondents (n=579)/n (%)	Ranking
Adding clinical research-related courses in the school training stage of doctors and nurses	323 (55.8)	1
Guiding new people and helping them in teams by tutors with clinical research experience	287 (49.6)	2
Carrying out short-term on-the-job training and teaching with cases	279 (48.2)	3
Participating in high-level and standardized clinical research projects	208 (35.9)	4
Conducting expert forums to promote peer exchanges	180 (31.1)	5
Joint training with enterprises with clinical research experience, and short-term exchange of talents	148 (25.6)	6
Others	2 (0.3)	7

图5 临床研究人才队伍扩充关键途径的帕累托图Note： A. Recruiting clinical research practitioners with relevant qualifications from the society, and carrying short-term training. B. Increasing clinical research courses in the training of medical statistics, preventive medicine, clinical nursing, medical laboratory and other related majors. C. Increasing the enrollment of clinical research methodology, and cultivating clinical research professionals. D. Setting clinical research degree points to attract and cultivate graduate level clinical research methodology talents. E. Setting special clinical research posts, improving the professional title evaluation and employment scheme, and improving the career stability of clinical researchers. F. Others.

Fig 5 Pareto diagram of key approaches to expand clinical research talents

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