A Survey of the Current Situation of Clinical Biobanks in China

Abstract

The development of biomedical research urgently needs the support of a large number of high-quality clinical biospecimens. Therefore, human biobanks at different levels have been established successively in China and other countries at a significantly increasing pace in recent years. To better understand the general current state of clinical biobanks in China, we surveyed 42 clinical biobanks based in hospitals and collected information involving their management systems, sharing mechanisms, quality control systems, and informational management systems using closed questionnaire methods. Based on our current information, there has not been such a large-scale survey in China. An understanding of the status and challenges current clinical biobanks face will provide valuable insights for the construction and sustainable development of higher quality clinical biobanks.

Introduction

Due to the rapid development of high-throughput biotechnology, -omics technology, and big data analytics, progress in the evolution toward personalized medicine has accelerated in recent years. Translational medicine, precision medicine, and dedicated programs for chronic diseases have become critical components of the national medical science and technology strategy in China. The development of medical research urgently needs increasing numbers of high-quality clinical biospecimens. Therefore, human biobanks at different levels have been established worldwide at an increasingly rapid pace.^1,2 Human biobanks can be classified into population-oriented biobanks and disease-oriented biobanks, the latter also known as clinical biobanks.³ As early as 1994, China established the Immortalized Cell Bank of Different Chinese Ethnic Groups. Later, in 2003, construction of the Bank of Chinese Genetic Resources was initiated. After 2005, there was a wave of construction of biobanks in China. Beijing, Shanghai, and Shenzhen each has established regional biobanks with financial support from local governments and the National Science Project and have since become the predominant players in this area.⁴ Clinical biobanks, due to their complexity and their usual origins in healthcare institutions, are often built inside hospitals with independent operating space and various management systems.⁵ Like most biobanks in the world, they also face challenges in issues concerning scale, sharing, personnel, capital, policy, and so on.⁶

The objective of the article is to provide a better understanding of the general status of clinical biobanks in China. Because most of the clinical biobanks are operated by hospitals, we distributed the questionnaire to hospital biobankers to collect information about the management systems, sharing mechanisms, quality control systems, and information support capabilities. Based on this survey, we analyzed the status and challenges facing current clinical biobanks and proposed suggestions for the construction and sustainable development of higher quality clinical biobanks.

Materials and Methods

Research objectives

The purpose of this study was to carry out a general survey about the status of domestic clinical biobanks. In December 2015, we interviewed a few selected biobankers about the current condition of their biobanks, using open-ended questionnaires. Based on the results from the questionnaire and the experience in the Beijing Biobank of Clinical Resources for 7 years, we designed a set of closed questionnaires. In March 2016, the closed questionnaire was pretested by five experts, including statisticians and biobankers. According to the results of the pretest, some questions and possible answers were modified. The formal questionnaire included 5 aspects and 27 questions, including both individual opinions and factual data about the biobank.

In May 2016, we performed the survey using an anonymous questionnaire with closed answers, with 42 active clinical biobanks mainly from healthcare institutions in provinces such as Beijing, Shanghai, Jiangsu, and Guangdong. Each hospital completed only one questionnaire. The questionnaires were filled out online, with IP addresses as well as completeness of answers strictly controlled.

Analytical methods

This study uses qualitative methods, where the answers of all questionnaires are tallied and then key options are selected to conduct a descriptive analysis. As to multiple choice questions, the percentage of the number of options selected from the total number of answers and the content of the questions are combined to carry out a descriptive analysis. There are also multiple choice questions where participants are asked to choose multiple answers and rank the answers in order of importance or relevance. For these questions, the results are calculated based on the weighted average of the answers' frequency of being chosen and their ranking. These results are then analyzed qualitatively.

Results

The fundamental situation

For the number of years the biobank has been in existence, the number of those clinical biobanks having been constructed 2–5 years ago, 6–9 years, and over 10 years account for 35.7%, 40.5%, and 11.9%, respectively.

For the size of the biobanks, the number samples with over 6000 and 10,000 cases eligible for study account for 57.1% and 40.5%, respectively; those with over 30,000 and over 100,000 specimens account for 64.3% and 40.5%.

For the storage facility, the clinical biospecimens are mainly stored independently in hospitals, accounting for 85.7%.

As for the sources of funds, clinical biobanks usually have three major funding sources: self-funding in the hospitals, government funding, and project funding (Table 1), of which the hospital-raised funds takes up a large proportion, capable of providing about 83% of the clinical biobanks with more than half of their total funds. The investment in 78.6% of the clinical biobanks can basically meet the demands of construction.

Table 1.

Sources of Funds of Clinical Biobank Construction (Please Answer with %)

	Sources of funds
Proportion	Self-funding in the hospital, %	Government funding, %	Project funding, %	Social investment (Enterprises), %	Cost recovery, %	Others, %
0	7.14	40.48	23.81	95.24	92.86	90.48
<30%	9.52	14.29	38.10	2.38	7.14	9.52
30% (including) – 60%	50.00	35.71	23.81	2.38	0.00	0.00
60% (including) – 90%	14.29	7.14	11.90	0.00	0.00	0.00
≥90%	19.05	2.38	2.38	0.00	0.00	0.00

About the running state, 3 think the running state is very well and 19 think it is well, the 2 categories accounting for 52.4% of the 42 biobanks. As for the reasons why they think they are running very well and well, the top three reasons were a high level of attention from hospital management; high-level design and efficient execution; and sufficient funding. The respective weight ratios are 35.9%, 23.15%, and 15.98%, followed by adequate professionals, whose weight ratio is 12.78%.

The current management and its influencing factors

In terms of the committees, in 39 (92.9%) clinical biobanks, there are management committees and executive teams. As for staffing, it is stated that there are insufficient numbers of employees in 73.8% of the biobanks and that the professional skills of the staff in 45.2% of the biobanks can meet the demands of their development, but that the personnel composition in half of the biobanks cannot fulfill their future needs.

When looking at the career status of the staff, one employee who works on multiple posts exists in 66.7% of the 42 biobanks. Staff is lacking creativity and initiative in daily work exists in 61.9%. In some biobanks, the personnel receive low pay (38.1%), unclear career advancement leads to lack of motivation (35.7%), and staff need more professional training (47.6%).

As for factors influencing the management system, the top 3 the attention by leadership at the hospital (32.9%), coherent management regime (28.6%), interdepartmental cooperation (14.3%), followed by well staffed (13.1%).

The sharing of resources and its influencing factors

In terms of the usage rate of biospecimens (tubes), 13 (31%) biobanks scored below 10%, 18 (42.9%) scored between 10% and 30%, 10 (23.8%) between 30% and 50%, and 1 (2.4%) above 50% (Table 2).

Table 2.

The Usage Rate of Biosamples (Tubes) in Your Biobank

Items of usage rate, %	The number of sample banks	Percentage
<10	13	30.95
10–30	18	42.86
30–50	10	23.81
>50	1	2.38

The factors influencing usage rates include the research capabilities (36 biobanks, 85.7%), the level of dependence on resources (32 biobanks, 76.2%), the quality of resources (25 biobanks, 59.5%), the quantity of resources (20 biobanks, 47.6%), the diversity of diseases (21 biobanks, 50%), the other institutions' needs (13 biobanks, 31%), and the difficulty of applying to use samples (9 biobanks, 21.4%).

By the order of factors influencing other institutions' success in applying to use samples, they are the research collaboration with the hospital, good research ideas, requested by higher authorities or management at the hospital, and high cost recovery for using the samples. Ten biobanks are not clear about the factors because few other institutions apply for samples.

Data on how to collaborate with others on sharing the resources were also collected. Seventeen biobanks (40.5%) share intellectual property, but do not charge a fee for using the samples, 14 (33.3%) share intellectual property and charge a fee for using the samples, 4 (9.5%) do not share intellectual property and charge a fee for using the samples, and 1 biobank (2.4%) neither shares intellectual property nor charges a fee for using the samples.

We also looked at data on the reasons samples and data are collected. Results showed that 36 (85.7%) do so for potential research projects in the future; 29 (69%) do so for specific research projects; 11 (26.2%) reported no reasons; and 5 (11.9%) said they respond to requests from the clinicians.

Finally, we looked at data on how the diseases were selected. Seventeen biobanks (40.5%) reported that specific diseases were studied in research projects, 10 (23.8%) reported that the quantity of disease cases was large in the hospital; 10 (23.8%) reported that the diseases were those the biobank deemed valuable for future research; and 5 (11.9%) reported that they studied all the clinical diseases in the hospital.

Among the factors affecting sample sharing, the top three are policy (28.6%), the lack of regulations and laws (19.8%), and the lack of standard procedures compared with other institutions (19%), followed by the cost associated with sharing samples (18.7%), and the insufficient quantity of samples to share with other institutions (13.5%).

Quality management and its influencing factors

In terms of when does the quality control process begin for a biobank, 14 begin when patients are involved, 11 begin when research projects are designed, 10 begin when samples are collected from patients, and 6 begin when the samples are processed.

With regard to the contents of standard operating procedures (SOPs), all of the 42 biobanks surveyed have sample collection, processing, and storage SOPs, 37 have a clinical data collection SOP and patient consent SOP, 35 have data and sample sharing SOPs, 28 have SOP revision and feedback SOPs, and 22 have staff hiring and training SOPs.

As to what the evaluation of sample and data quality should be based upon, 36 biobanks think the evaluation should include whether they meet research needs, 35 think the evaluation should include data accuracy and reliability, 32 think the evaluation should include the traceability, and 13 think the evaluation should include the quantity.

In terms of the factors influencing data quality, the top three are the function of the data collection system (23.4%), the frequency and method (Automatic\Manual\second-time) (20.2%), and the content of data collected (15.9%).

Data on the factors influencing sample quality were also collected. The top three are methods and timeliness of sample collection (26.98%); the reagents used to process samples; processing methods and timeliness (18.3%); and the functionality of sample quality control systems (15%).

Among the factors that affect the quality of samples and data collected, the top three are the leadership and management team's focus (25%); the execution of SOPs and quality control (27.8%); and the design of the clinical research project (19.4%) (Table 3).

Table 3.

What Are the Factors That Affect the Quality of Samples and Data Collected

Items	Weight, %
Leadership and management team's focus	25
Design of clinical research project	19.44
Execution of SOPs and quality control	27.78
Coherence of quality control systems	18.25
Usage rates of samples and data	1.19
Staff skill level	6.35
Number of full-time employees	1.98

SOP, standard operating procedure.

The information management system and its influencing factors

We surveyed the primary status of the information management systems of biobanks in China. With respect to how satisfied are you with the current information management system, 5 biobanks (11.9%) responded that they are very satisfied, 26 (61.9%) responded that they are satisfied, while 10 (23.8%) responded that they are not satisfied.

In terms of how well do you think the current information management system meets the needs of clinical research projects, 4 (9.5%) think it meets the needs well, 25 (59.5%) think it is average, and 13 (31%) think it is poor.

We also identified the main issues that arise in the process of collecting sample data in the information management system. The top 3 are: the data is not complete (25.8%); there are procedural obstacles in collecting data (19.8%); and the clinical data module and management module need improvement (17.9%) (Table 4 and Supplementary Appendix; Supplementary materials are available online at www.liebertpub.com/bio).

Table 4.

A Sequence of Problems of the Information Management System in the Process of Data Collection and Data Storage

Items	Weight, %
Data are not complete	25.79
There is procedural obstacle in collecting data	19.84
Data lack traceability	9.52
Data are not screened so there are lots of unusable data	3.97
Data reliability and effectiveness are not tested	5.56
Data security is still a concern	3.17
IMS of biobank is not compatible with the hospital's, so it is difficult to do the integration	14.29
The information system for sample location and storage is mature, but clinical data module and management module need improvement	17.86

Discussion

A clinical biobank is characterized by complexity, sustainability, and a large investment, meaning that its construction is a complicated, comprehensive, and systematic project,⁷ involving not only technical problems but also issues concerning management, personnel, informatics, and quality control. According to the survey results from the five aspects of basic biobank conditions, management systems, resource sharing, quality control, and information management systems, the status of Chinese domestic clinical biobanks is described as follows:

Fundamental situation

Our results show that at present, the size of most of China's clinical biobanks is above average compared with their international counterparts,⁸ with most biobanks fully equipped with independent storage space. Many biobanks in Europe and the United States rely on public agency funding, university institutional funding, or external funding, and the funds can sometimes be insufficient.^9,10 Biobanks in China are funded mostly by the hospital itself and thus meet basic running costs. These biobanks have their own full-time teams and are operating adequately. Factors such as top-level design, adequate attention from administrators, personnel, capital, and the participation of clinicians can influence their overall operations.

Development of their management systems

As an organization, a biobank's management team should exert the functions of planning, organization, leadership, and control. Management of biobanks is also specified in best practice guidelines released by such organizations as ISBER and NCI.^11,12 At present, clinical biobanks have witnessed a rapid growth in terms of top-level design and management organization. Since a clinical biobank in the hospital relies heavily on its information department, clinical department, laboratory department, and its department of infrastructure, the attention and the coordination ability from the leader and the cooperation between these departments influences the development of the overall biobank. All of these reasons above, coupled with a lack of personnel, have limited the effectiveness of some biobanks.

Sharing

Clinical biobanks have developed to meet an increasing need for quality medical research.¹³ According to a research finding by the RAND Corporation, the collection of biological samples has been in existence for more than 100 years in the United States.¹⁴ Therefore, the goals of clinical biobanks should be oriented to the needs of medical research. Our research findings show that the usage rate of China's clinical biobanks is rather low. The usage rates in other countries are sometimes similar, for example, a blood biobank in France reported a usage rate of only 0.025%.^15–17 Medical researchers use these resources at a speed far behind that of the accumulation of biosamples. According to our research findings, the reasons for the low usage rate in our domestic clinical biobanks include, first, the lack of top-level design on the criteria for the enrollment and collection, which leads to difficulty to guarantee the resource quality and causes limited sharing and application. The second reason is that the research basis and the research capability may also influence the speed of resource utilization. The third factor is that diverse standards and inadequate sharing mechanisms pose challenges for the ability to achieve resource sharing. Thus, more resources cannot be integrated and the development of research projects is restricted. Finally, because funds mostly come from the hospital, biobanks are more likely to be accessed by researchers in the same hospital.

Quality control

Total quality management involves full coverage, continuous improvement, and active participation as the three pillars in the quality control process, demonstrating that quality control points should be set in every link of the process, emphasizing full participation, entire process control, and establishing the thinking mode of continuous improvement.¹⁸ Besides, at the starting point of quality control, the quality control program needs to be developed, and quality control points should be clarified. In a period of rapid development, comprehensive collection used as strategic reserve exists side by side with the project-driven collection for special projects in our domestic clinical biobanks¹⁹ leading to the sharp difference in the starting point of each biobank, some at the time when the research project is designed, others at the point when the patients are enrolled, or even later. In recent years, although progress has been made in raising standards, staff training, and the construction of quality control systems, domestic clinical biobanks are still relatively lacking in the construction of clinical data quality controls. In addition, due to the limitation of the personnel and funding, the quality control system is often not fully executed. Therefore, on the basis of clarifying the perspective and the design, emphasis should be on improving execution, details, and validation in the construction of our domestic clinical biobanks.

Information management system

The most prominent character of the information platform is that abundant clinical data should be accessed and new research data should be systematically integrated. Therefore, an information management system is absolutely essential in the construction of clinical biobanks.^20,21 At present, the majority of clinical medical data are unstructured and there are a variety of information systems with different functions used in hospitals, both of which are factors that produce many challenges to functions of the information system such as data integration, data standards, data tracing, and data management.^22–24 According to the survey, the information management systems applied in domestic clinical biobanks can basically meet the needs of the construction of most biobanks. However, the information management system is relatively weak in terms of its contribution to biobank construction and clinical research. The standards of data integrity are uncertain, which restrict the integration of big data in medicine. Compared with the relatively sophisticated system used for sample management, the clinical data capture system remains lacking in such aspects as automatic population data collection, data retracing, and data management.

Conclusion

This article reports on a general survey of the status of biobanks in China on the aspects of management, sharing, quality control, and information systems. However, the survey has provided biobankers more knowledge about their biobanks. Clinical biobanks in China have developed rapidly. Hopefully, we can leverage the knowledge in the survey to further study the development of biobanks in China in more detail.

In conclusion, both biobank builders and users should be fully aware of the complexity and diversity of clinical biobanks, the factors which limit the sharing or utilization of the resources, and give due consideration to these factors as their biobanks progress. To maintain the sustainable development of China's clinical biobanks, more attention needs to be paid to the top-level design, professionalization and specialization for the staff, participation of clinicians, financial backing, appropriation of resources, data security, and so on.

Footnotes

Acknowledgments

The authors appreciate the research funds from Beijing Municipal Science and Technology Commission. The authors would like to thank Fangzhou Qian for reviewing and improving the English in the article.

Author Disclosure Statement

No conflicting financial interests exist.

References

Jia-fu

. The Capacity Building and Best Practices for Biobanks, 1st ed. Beijing, Science Press; 2013.

Yu-cheng

. The Clinical Biobank, 1st ed. Beijing, Science Press; 2014.

Asslaber

, Zatloukal

. Biobanks: Transnational, European and global networks. Brief Funct Genomics Proteomic, 2007; 6:193–201.

Gan

, Wang

, Song

, et al. Chinese biobanking initiatives. Biopreserv Biobank, 2015; 13:4–7.

Cheng

, Shi

, Wang

, et al. Chinese biobanks: Present and future. Genet Res (Camb), 2013; 95:157–164.

Zhang

, Li

, Wang

, et al. China biobanking. Adv Exp Med Biol, 2015; 864:125–140. Review.

Hai-yan

, Lei

, Xue-jiao

, et al. Preliminary study on the construction of clinical biobank of major diseases in Beijing. Chin J Hosp Admin, 2013; 29:863–865.

Simeon-Dubach

, Watson

. Biobanking 3.0: Evidence based and customer focused biobanking. Clin Biochem, 2014; 47:300–308.

Zika

, Paci

, Braun

, et al. A European survey on biobanks: Trends and issues. Public Health Genomics, 2011; 14:96–103.

10.

Cadigan

, Lassiter

, Haldeman

, et al. Neglected ethical issues in biobank management results from a U.S. study. Life Sci Soc Policy, 2013; 9:1–13.

11.

Campbell

. ISBER Best Practices for Repositories: Collection, Storage, Retrieval and Distribution of Biological Materials for Research. 2012. www.isber.org/?page=BPR (accessed April 2016 ).

12.

Biorepositories and Biospecimen Research Branch, National Cancer Institute, National Institutes of Health. NCI Best Practices for Biospecimen Resources. 2016. https://biospecimens.cancer.gov/bestpractices/2016-NCIBestPractices.pdf (accessed April 2016 ).

13.

De Souza

, Greenspan

. Biobanking past, present and future: Responsibilities and benefits. AIDS, 2013; 27:303–312.

14.

Eiseman

, Bloom

, Brower

, et al. Human Tissue Repositories. Arlington, VA, RAND; 2003.

15.

Oushy

, Palacios

, Holden

, et al. To share or not to share? A survey of Biomedical Researchers in the U.S. Southwest, an ethnically diverse region. PLoS One, 2015; 10:e0138239.

16.

Roberts

, Karvonen

, Graham

, et al. Biobanking in the twenty-first century: Driving population metrics into biobanking quality. Adv Exp Med Biol, 2015; 864:95–114.

17.

Sapey

, Py

, Barnoux

, Tessier

, Dehaut

. EFSC Centre-Atlantique donor's biobank: Ten years of sample usage. Transfus Clin Biol, 2016; 23:95–97.

18.

Hua-jie

. The quality management in scientific projects of university by total quality management. R&D Manage, 2011; 23:121–125.

19.

Gottweis

. Good biobank governance: How to avoid failure. Medicine and Philosophy, Humanistic & Social Medicine Edition. 2009; 30:8–12.

20.

Quinlan

, Groves

, Jordan

, et al. The informatics challenges facing biobanks: A perspective from a United Kingdom Biobanking Network. Biopreserv Biobank, 2015; 13:363–370.

21.

Hai-yan

, Xue-jiao

, Xue-mei

, et al. Importance of disease bio-banks and status quo arIalrsis. Chin J Hosp Admin, 2010; 26:801–804.

22.

Hai-xin

, Na

, Ke-xin

. The present situation and prospect of the biobank informatization construction. China Cancer, 2015; 24:262–266.

23.

Ai-hua

, Chang

, Pei-ying

, et al. The exploration of the clinical information integration in biobank. Chin Med Biotechnol, 2015; 10:501–502.

24.

Fearn

, Michels

, Meagher

, et al. 2012 International Society for Biological and Environmental Repositories Informatics Working Group: Survey Results and Conclusions. Biopreserv Biobank, 2013; 11:64–66.

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