Current Issues in China Clinical Trial Patient Recruitment and Retention

1. January, 2012

2. 0 One of the biggest hindrances to clinical trials is the lack of patient
participation. Failure of patient recruitment and retention is the
most common cause of delays in market-launch in the US.
Competing for patient resources and failure of investigators to meet
planned patient recruitment goals are also common problems in
clinical trials in China. Despite satisfactory reports of patient
recruitment rates in global trials conducted by major multinational
firms, many local Chinese pharmaceutical trials have difficulty
meeting required timelines due to noncompliance of patients and
investigators, unwillingness of physicians to enroll patients, overly
rigorous inclusion and exclusion criteria, and competing trials.

3. 0 The majority of the Chinese population seeks out
traditional Chinese Medicine (TCM) and the government
has structured the reforms to favor hospitals with
expertise in TCM. The widespread concurrent use of
TCM with Western pharmaceutical products represents a
challenge with respect to clinical trial design and
interpretation of trial data.

4. 0 This presentation is to provide resources for planning
and managing clinical trials in China by highlighting
patient populations with major diseases, State Food and
Drug Administration (SFDA) GCP certified clinical trial
sites, and the commonly used Traditional Chinese
Medicine (CTM).

5. Overview of Chinese Population Growth Rate in
Urban and Rural Areas, and by Age Groups
160000 80
120000 60
Population (10,000)
Rate (%)
80000 40
40000 20
0 0
Year
1982 1990 1995 2000 2005 2006 2007 2008 2009
Urban Rural 0-14 age 15-64 age >65 age

6. Ten Leading Course of Death in Urban and Rural
Areas
0 50 100 150 200
Malignant Neoplasmas
Cerebrovascular Disease
Heart Diseases
Respiratory System
Injury & Poisoning
Endocrine/Nutritional/Metabolic…
Digestive System
Genitourinary System Urban
Nervous System
Rural
Infectious Diseases
Mortality Rate = total deaths ( caused by diseases) at reference period/average population at same
period x 100%.

7. Morbidity Rates of 10 Major Chronic Diseases
(%) in Urban & Rural Areas in 2009
0 40 80 120
Hypertension
Diabetes
Cerebrovascular disease
Ischaemic heart disease
Intervertebral disc disorder
Gastroenteritis
Rheumatoid arthritis
COPD
Cholelith & Cholecystitis Urban Rural
Peptic ulcer
Mortality Rate = total deaths ( caused by diseases) at reference period/average
population at same period x 100%.

8. Rates of Urban And Rural Area
Outpatient/Office Visits in 2008 (0/00)
0 10 20 30 40 50
Acute Upper Respiratory Infection
Hypertension
Heart Disease
Diabetes
Acute Gastritis
Genitourinary Diseases
Cerebrovascular Diseases
COPD
Arthritis
Cancer
Gallbladder Disease
Infectious Diseases
Pneumonia Urban Rural
Cirrhosis

9. Rates of Urban and Rural Area Inpatient
Hospital Stays in 2008 (0/00)
0 2 4 6 8 10
Heart Disease
Cerebrovascular Diseases
Hypertension
Cancer
Diabetes
Genitourinary Diseases
Gallbladder Disease
COPD
Acute Upper Respiratory Infection
Pneumonia
Acute Gastritis
Infectious Diseases
Arthritis Urban Rural
Cirrhosis

10. Two-week Hospital Outpatient Visit Rate by
Age in 2008
A 350
Two-week hospital visit rate by age (‰)
Urban Rural
300
250
200
150
100
50
0
0-4 5-14 15-24 25-34 35-44 45-54 55-64 >65
Age (year)

11. Two-week Hospital Outpatient Visit Rate by
Hospital Level & Preference (2008)

12. Percentage of Drug and Traditional Chinese
Medicine Usages

13. Urban and Rural Household Income and
Healthcare Expenditure (Yuan, 2008)
16000
Disposable
Income, 15,781
12000
Non-productive
Expenditure, 11,2
Yuan
8000 43
Net
Income, 4,761 Non-productive
4000
Expenditure, 3,66
Healthcare, 786 1
Healthcare, 246
0
Urban Rural

14. Average Expenses of General Hospital Outpatient
Visits and Inpatient Stays (Yuan/per patient, 2008)
10000
1000
Patient Fee (Yuan)
100
10
1
Medication Diagnostic & Treatment Other
Out-patient (per visit) In-patient (per patient)

15. Current China Clinical Trials Registered in
Chinese Clinical Trial Registry

16. Overview of 10 Year New Chemical Entity (NEC)
SFDA Applications
2001-2010 Class I New Chemical Entity SFDA Application

17. 0 Mortality rates of major diseases were relatively higher in
rural than in urban areas. Morbidity rates of cardiovascular
disease and diabetes were higher in cities, and morbidity rates
of acute upper respiratory infection, pneumonia, acute
gastritis, infection, cirrhosis were higher in countries. High
two-week hospital visit rate was reported in rural area by all
age groups. People in rural area were less likely visit above
prefecture-level hospitals. Short distance and high level
expertise of physicians were major factors for selecting
hospital visits. Current SFDA GCP certified over 400 clinical
trial sites are hospitals at above county levels, therefore
including patients in rural areas can be a challenge.

18. 0 Although incidences of infectious diseases were relative
low, anti-microbial agents were top rated drugs used in hospitals.
Main applications of Traditional Chinese medicine (TCM) were
Cardio/Cerebrovascular diseases, cancer, respiratory
diseases, and musculoskeletal disorders. Wide use of TCM and
other medications might require extra caution on designing and
selecting study subjects. Majority China clinical trials can be
found at clicinaltiral.gov (NIH) and Chinese Clinical Trial Registry;
these are good resources for identify competing trials for study
subjects. Information presented above might provide valuable
resources for analyzing threats and opportunities in China
clinical trial patient recruitment and retention.

19. REFERENCES AND USEFUL LINKS
• Health statistics: http://www.stats.gov.cn/tjsj/ndsj/2010/indexeh.htm
• pre-clinical study site list:
http://app1.sfda.gov.cn/datasearch/face3/base.jsp?tableId=11&tableName
=TABLE11&title=临床前研究单位备案名单
&bcId=118714711342967566418335831165
• SFDA GCP certified study site list:
http://app1.sfda.gov.cn/datasearch/face3/base.jsp?tableId=19&tableName
=TABLE19&title=药物临床试验机构名单
&bcId=118714941832181502104731901420
• SFDA new drug clinical trial list:
http://app1.sfda.gov.cn/datasearch/face3/base.jsp?tableId=8&tableName=
TABLE8&title=%C5%FA%D7%BC%C1%D9%B4%B2%D1%D0%BE%BF%B5%C4
%D0%C2%D2%A9&bcId=124356683643430217478147499292