Assessing Compliance and Satisfaction Among Participants in Clinical Trials on Traditional Chinese Medicine

Figures & data

Table 1 Basic Demographic Information of the Participants (n=88)

Characteristic		n	%	Characteristic		n	%
Sex	Male	19	21.59	Annual Income (10k Yuan)	<1	14	15.91
	Female	69	78.41		1–5	19	21.59
Age (years)	18–40	71	80.68		5–10	23	26.14
	41–60	12	1.13		10–20	22	25
	≥ 61	5	5.68		> 20	10	11.36
Educational level	≤ junior high	2	2.27	Number of clinical trials previously participated in (including current)	1	70	79.55
	High school	8	9.09		2–5	17	19.31
	Technical Secondary School/Junior College	18	20.45		6–10	1	1.14
	Bachelor’s Degree	29	32.95
	Master’s Degree and above	31	35.23
Occupation	Employed	67	76.13
	Freelancer	3	3.41
	Student	14	15.91
	Retired	2	2.27
	Unemployed	2	2.27

Figure 1 Understanding of “Clinical Trials” and “Clinical Trial Participants” among 88 Participants.

Table 2 Levels of Understanding of the Concept of “Clinical Trials” and “Clinical Trial Participants” Among 88 Participants with Differing Educational Backgrounds

Topic	Understanding Level	Education Level: n (%)					Total	χ^2	p
		Junior High	High School	Technical Secondary School/Junior College	Bachelor’s Degree	Master’s Degree
Clinical Trials	Very thorough understanding	0 (0.00)	0 (0.00)	6 (33.33)	6 (20.69)	16 (51.61)	28 (31.82)	34.68	0.001**
	Relatively good understanding	0 (0.00)	7 (87.50)	7 (38.89)	17 (58.62)	14 (45.16)	45 (51.14)
	Limited understanding	2 (100.00)	1 (12.50)	5 (27.78)	3 (10.34)	1 (3.23)	12 (13.64)
	No understanding	0 (0.00)	0 (0.00)	0 (0.00)	3 (10.34)	0 (0.00)	3 (3.41)
Clinical Trial Participants	Very thorough understanding	0 (0.00)	0 (0.00)	10 (55.56)	9 (31.03)	17 (54.84)	36 (40.91)	33.75	0.001**
	Relatively good understanding	0 (0.00)	7 (87.50)	4 (22.22)	15 (51.72)	13 (41.94)	39 (44.32)
	Limited understanding	2 (100.00)	1 (12.50)	4 (22.22)	3 (10.34)	1 (3.23)	11 (12.50)
	No understanding	0 (0.00)	0 (0.00)	0 (0.00)	2 (6.90)	0 (0.00)	2 (2.27)

Note: **p < 0.01

Table 3 Factors Influencing Participants’ Willingness to Partake in Clinical Trials: Category a (Major Factors), Category B (Minor Factors), and Category C (General Factors)

Number	Influencing Factors	Frequency/Rate	Proportion(%)	Cumulative Percentage(%)	Factor
1	Desire to contribute to the medical field	53	21.90%	21.90%	A
2	Access to additional medical information	32	13.22%	35.12%	A
3	Enrichment of personal life experiences	27	11.16%	46.28%	A
4	Trust in hospitals and physicians	27	11.16%	57.44%	A
5	Additional opportunities for treatment	26	10.74%	68.18%	A
6	Free examinations and treatments	21	8.68%	76.86%	A
7	Desire to assist researchers in completing the trial	20	8.26%	85.12%	B
8	Related compensation and (or) rewards	12	4.96%	90.08%	C
9	Belief that the physicians and staff conducting the clinical trials are leading experts in their field	9	3.72%	93.80%	C
10	Perception that the risks associated with clinical trials are not excessively high	7	2.89%	96.69%	C
11	Hope that they will receive more attention from doctors	5	2.07%	98.76%	C
12	Family and (or) financial pressures	2	0.83%	99.59%	C
13	Belief that it is appropriate for their individual health condition	1	0.41%	100.00%	C

Table 4 Factors Influencing Participants’ Hesitation to Partake in Clinical Trials: Category a (Major Factors), Category B (Minor Factors), and Category C (General Factors)

Number	Influencing Factors	Frequency/Rate	Proportion(%)	Cumulative Percentage(%)	Factor
1	Fear of the risks and side effects to the body	9	19.15%	19.15%	A
2	Worry that they will not receive effective treatment	7	14.89%	34.04%	A
3	Unknown rights and responsibilities	6	12.77%	46.81%	A
4	Unknown qualifications of the research institution and the medical professionals	5	10.64%	57.45%	A
5	Unknown specific information about the experimental drug	5	10.64%	68.09%	A
6	Worry about being in the placebo group	4	8.51%	76.60%	A
7	Breach of personal privacy	4	8.51%	85.11%	B
8	Unknown specific details of the clinical trial	3	6.38%	91.49%	C
9	Family disapproval	2	4.26%	95.75%	C
10	Discrimination	2	4.26%	100.00%	C

Table 5 Factors Influencing Participants’ Unwillingness to Partake in Clinical Trials: Category a (Major Factors), Category B (Minor Factors), and Category C (General Factors)

Number	Influencing Factors	Frequency/Rate	Proportion(%)	Cumulative Percentage(%)	Factor
1	Frequent blood draws during the trial process	3	17.65%	17.65%	A
2	Long trial period	3	17.65%	35.30%	A
3	Side effects of drugs on the body	2	11.76%	47.06%	A
4	Family disapproval	2	11.76%	58.83%	A
5	Clinical trial-required examinations and procedures adding extra burden (such as physical discomfort and pain)	1	5.88%	64.71%	A
6	Excessive number of trial visits	1	5.88%	70.59%	A
7	Strict self-management requirements	1	5.88%	76.47%	A
8	Tedious diary cards, measurement scales, and other log files	1	5.88%	82.36%	B
9	Large dosages or excessive treatment	1	5.88%	88.24%	B
10	Financial stability	1	5.88%	94.12%	C
11	Unwilling to be in the placebo group	1	5.88%	100.00%	C

Figure 2 Factors Influencing Participants’ Willingness to Partake in Clinical Trials.

Figure 3 Factors Influencing Participants’ Hesitation to Partake in Clinical Trials.

Figure 4 Factors Influencing Participants’ Unwillingness to Partake in Clinical Trials.

Figure 5 Perceived Benefits from Participation in Clinical Trials.

Table 6 Confidence Levels Regarding the Efficacy of Experimental Drugs Among Participants with Different Occupations

Confidence Level	Occupation: n (%)					Total	χ^2	p
	Employed	Student	Unemployed	Freelancer	Retired
Confident	34 (50.75)	8 (57.14)	0 (0.00)	1 (33.33)	0 (0.00)	43 (48.86)	17.90	0.022*
Neutral	7 (10.45)	1 (7.14)	1 (50.00)	1 (33.33)	2 (100.00)	12 (13.64)
High Confident	26 (38.81)	5 (35.71)	1 (50.00)	1 (33.33)	0 (0.00)	33 (37.50)

Note: *p < 0.05

Table 7 Willingness Level to Participate in Clinical Trials Among Different Population Groups Based on Their Level of Confidence in the Effectiveness of Drugs Trials

Willingness Level	Confidence Level: n (%)			Total	χ^2	p
	High Confident	Confident	Neutral
Willing	33 (100.00)	35 (81.40)	6 (50.00)	74 (84.09)	20.92	0.000**
Slightly Hesitant	0 (0.00)	6 (13.95)	6 (50.00)	12 (13.64)
Unwilling	0 (0.00)	2 (4.65)	0 (0.00)	2 (2.27)

Note: **p < 0.01

Table 8 Overall Satisfaction Ratings of 88 Participants in Clinical Trials

	Very Satisfied	Satisfied	Neutral	Dissatisfied	Very Dissatisfied	N/A
Q15	45(51.14%)	37(42.05%)	6(6.82%)	0(0.00%)	0(0.00%)	0(0.00%)
Q16	49(55.68%)	32(36.37%)	7(7.95%)	0(0.00%)	0(0.00%)	0(0.00%)
Q17	56(63.64%)	26(29.55%)	5(5.75%)	0(0.00%)	0(0.00%)	1(1.14%)
Q18	48(54.55%)	33(37.50%)	7(7.95%)	0(0.00%)	0(0.00%)	0(0.00%)
Q19	50(56.82%)	30(34.09%)	7(7.95%)	1(1.14%)	0(0.00%)	0(0.00%)
Q20	46(52.27%)	35(39.77%)	5(5.75%)	2(2.27%)	0(0.00%)	0(0.00%)
Q21	47(53.41%)	35(39.77%)	6(6.82%)	0(0.00%)	0(0.00%)	0(0.00%)
Q22	44(50.00%)	31(35.23%)	11(12.64%)	1(1.14%)	1(1.14%)	0(0.00%)
Q23	46(52.27%)	37(42.05%)	4(4.55%)	1(1.14%)	0(0.00%)	0(0.00%)
Q24	45(51.14%)	39(44.31%)	4(4.55%)	0(0.00%)	0(0.00%)	0(0.00%)
Q25	43(48.86%)	36(40.91%)	6(6.82%)	0(0.00%)	0(0.00%)	3(3.41%)
Q27	38(43.18%)	36(40.91%)	11(12.50%)	3(3.41%)	0(0.00%)	0(0.00%)
Q28	44(50.00%)	40(45.45%)	3(3.41%)	1(1.14%)	0(0.00%)	0(0.00%)

Figure 6 Satisfaction with Staff from 88 Participants in Clinical Trials.

Figure 7 Satisfaction Among Clinical Trial Process from 88 Participants in Clinical Trials.

Table 9 Additional Unmet Needs

Category	Demand
Clinical Trial Design	Want to obtain the original copy of the laboratory test results
	Want to know laboratory examination results
	Want to obtain an interpretation of the laboratory test results
	Want the compensation to be higher
	Want a transportation subsidy.
	Want the treatment to improve condition or lead to a full recovery
Quality of Researchers	Want researchers to listen more closely and patiently address any questions
	Want researchers to take on more responsibility rather than passing tasks onto their assistants
	Want to know the outcome of the clinical trial.
	Want to know the effects on my body after participating in the clinical trial.

Table 10 Recommendations for Enhancing Satisfaction Among Clinical Trial Participants

Classification	Suggestion
Clinical Trial Design	Simplify the trial process
	Shorten the duration of each visit
	Simplify medication administration
	Improve the efficacy of experimental treatments
	Raise compensation for participants
Establishment of Trial Institutions	Limit changing investigators in clinical trials
	Reduce waiting time for laboratory tests
Quality of Researchers	Clearly inform participants of the difference between the clinical trial and clinical treatment.
	Enhance communication with participants by providing trial updates, laboratory test results, treatment efficacy, potential impact on physical health, and overall conclusions of the study.
	Increase focus on the psychological needs of participants.

Data Sharing Statement

The data that support the findings of this study may be provided by the corresponding author upon reasonable request.