Demographic and Participation Details of Healthy Adult Human Participants of Early Phase Bioequivalence Pharmacokinetic Endpoint Study
Sharad Desai1, Nilesh Patel2*
1Ph.D Research Scholar, Ganpat University, Ganpat Vidyanagar-384012, Mehsana, Gujarat, India.
2Associate Professor and Head, Department of Pharmacology, Shree S. K. Patel College of Pharmaceutical Education and Research, Ganpat University, Ganpat Vidyanagar-384012, Mehsana, Gujarat, India. *Corresponding Author E-mail: nileshcology127@gmail.com
ABSTRACT:
This paper presents the results of Demographic and Participation Details of Healthy Adult Human Participants of Early Phase Bioequivalence Pharmacokinetic Endpoint Study. For that data of 50 participants was collected using self-administered questionnaire. After ethics approval, data were collected between between Jul-21 and Aug-21 from Gujarat state of India. Results of demographic and participation details are tabulated by its frequency and percentage. Participants are participating more whose age range were 18-41 years, income less than one lakh, education below Higher Secondary and having private job or wage-earner. Age of first time participation was found in range of 18-41 years and frequency of number studies in which participant participated were found from 01 to 20 studies. Also Chi-Square results suggested there is significant (p < 0.05) relation (I) between the Education and Age of first time participation (II) between the occupation and number of times participated.
KEYWORDS: Questionnaire, Demographic, Volunteer, Clinical, BABE study.
INTRODUCTION:
Trends for clinical research is increasing day-by-day in India. This trends is increased since last one decade. This will increase further in upcoming years as there is continuous advancement of technology for new drugs development and many areas for disease pathophysiology are still untouched. Also India is tropical and sub-tropical region so it has variety of diseases and conditions and being most populous democracy, there is more patient pool to conduct the various clinical researches for devices, surgical procedures, treatments and drugs1.
Indian pharmaceutical industry is growing fast since last five decades2. The contribution is increased from 5% in year 1969 to 80% in year 2020. This evolution is in both global and domestic market2. Out of total global generic market, Indian pharmaceutical industry contributes 20% by volume and vaccine demand at 62%2. Many multinational companies are setting their plants in India because of availability of enough hard working competitive man-power and low running/operation cost.
In spite of Good Clinical Practise trained people, enough IT and medical infrastructure, proper regulatory and ethical guideline, one half execution cost, quality output and faster recruitment, India is facing difficulties to compete with other established countries like China, Singapore and Israel3. So to make India as a research hub, Indian Government, Industry and Regulatory agency had worked on policies as expectation stated by Yogendra and Biswa4. Exemption from Goods and Service tax is given to foreign pharmaceutical companies by Government of India since few last years and also New Drugs and Clinical Trials Rules was implemented with more clarity and broad scope.
Clinical research mainly done with participants who are patient or healthy. Patient participants are taking part in clinical research for free medicine, therapeutic benefits or to understand the disease from which they are sufferings. While purpose of healthy participant is different 5, 6. In one study major purpose for participation was found monetary gain while others minor interest were free medical check-up and interest of advancing science with benefit to the society7. Clinical research on healthy volunteers is done for generic drug approval application and to evaluate the safety, dose, and pharmacokinetics of new drugs/formulations8, 9.
Clinical research in healthy volunteer is mainly done for bio-equivalence study. Where the bio-equivalence is proven between generic and innovator drugs by comparing the pharmacokinetic parameters like AUC, Cmx and Tmax etc. While some other phase-one study like first-in-man is done to get the data of safety, dose and pharmacokinetics with small number of participants. Normally adult male and female are participating in such studies except the indication of product is for special age (like aripiprazole and brexpiprazole for geriatric population) and sex (like Estradiol in postmenopausal women). All such clinical studies are done after giving complete, satisfactory and transparent information about the trial and taking written consent from volunteer after following proper informed consent process but, many research paper stated such bioethical guideline is not being followed many time.
Demographic and participation details for participants of early phase bioequivalence pharmacokinetic endpoint study (‘the BEPK study) is hardly available in literature for Gujarat province of India. Also other people who are not participating but concerned about such participation remained curious to know the details of people who are participating in the BEPK study because of their inherent bias related to participants’ low socio-economic status like, poverty, illiteracy, lack of education and limited availability/access to health care10. Hence, this small study was designed to find out the fact about their demographic information and participation behaviour in the BEPK study.
METHOD:
Participants:
Respondents for this study was healthy adult human participants of early phase bioequivalence pharmacokinetic endpoint study. Total fifty participants were selected. Participants were given oral presentation of informed consent which includes the purpose and objective of this work. Post signing of informed consent form, participants were allowed to fill the questionnaire. Below inclusion and exclusion criteria were considered for participation. Inclusion criteria: (I) Ready to sign ICF and return the filled questionnaire (II) Healthy adult (> 18 years age) human participant of early phase bioequivalence pharmacokinetic endpoint study of Gujarat state of India (III) Able to communicate effectively. Exclusion criteria: (I) Refusal to sign ICF (II) Reject to comply with the survey procedures listed in ICF (III) Already participated in this study.
Study design:
Data collection for this cross-sectional and descriptive survey was done between Jul-21 to Aug-21 using questionnaire. The region for this study was Gujarat state of India. The questionnaires were distributed to the respondents and they were requested to return duly filled questionnaire. They were informed to fill the questionnaire by self only.
Ethical considerations:
This study was approved by Sangini Hospital Ethics Committee, Ahmedabad, India. Participants were informed about the voluntary participation (i.e. can withdraw the consent of participation anytime) in this study. Participants were assured about confidentiality of their personal information. Participants were informed about no monetary benefit will be provided except any cost incurred to complete the questionnaire.
Research tool:
Questionnaire with total 19 essential questions about demographic and participation details of respondents were prepared. Question have either categorical or close ended (in number) options. Questions were evaluated for face validity by subject matter experts. Eleven experts with experience in range of 1.00 to 14.00 years were requested to check the questionnaire from various perspectives like: grammar, clarity, unambiguity of items, correctness of spellings, structure of the sentences, font size, font space, structure of the instrument, proper format, legible printout, enough instruction, difficulty level and reasonableness of items in relation to the supposed purpose of the instrument. Questionnaire was finalized after changes proposed by experts.
Data collection:
Eligible participants were provided one legible print of questionnaire in their familiar language. The questionnaire was self-administered. Respondents were asked to return dully filled questionnaire.
Data analysis:
Collected data were coded and entered in excel by two different individual and then compared the data for error. Error was corrected after matching the answer with original information. To mention the demographic and participation details of respondents, the descriptive statistics were used. All the results were mentioned as percentage and count of each answer. To conclude the Chi-square test (to compares two variables) results, a p value of less than 0.05 was taken as statistically significant. All statistical analyses were done using IBM SPSS Statistics for Windows, Version 25.0, IBM Corporation. Released 2013.
RESULTS AND DISCUSSION:
Age:
Majority of respondents were in age range of 26-33 and 34-41 years. While only one respondent were from age range of 50-57 years. Along with above frequency of age, other ranges are stated in Table 1.
Table 1. Frequency and percent of Age range
|
Age (Yrs.) |
Frequency |
Percent |
|
18-25 |
08 |
16 |
|
26-33 |
19 |
38 |
|
34-41 |
18 |
36 |
|
42-49 |
04 |
08 |
|
50-57 |
01 |
02 |
Income Level
As stated in Table 2, majority i.e. 88% of respondents have income less than one lakh Rupees. However, only 04% respondents have income in range of 3,00,000 – 4,50,000 Rupees and rest have income range of 1,50,000 – 3,00,000 Rupees.
Table 2. Frequency and percent of Income level
|
Income (Rs.) |
Frequency |
Percent |
|
Less than 1,00,000 |
44 |
88 |
|
1,50,000 – 3,00,000 |
04 |
08 |
|
3,00,000 – 4,50,000 |
02 |
04 |
Education Qualification:
Education qualification data stated in Table 3 suggests, 50% participants have primary education while, rest 50% had passed secondary, higher secondary, diploma and graduate as mentioned in below Table 3.
Table 3. Frequency and percent of Education level
|
Age |
Frequency |
Percent |
|
Primary |
25 |
50 |
|
Secondary |
13 |
26 |
|
Higher Secondary |
07 |
14 |
|
Diploma |
01 |
02 |
|
Graduate |
04 |
08 |
Occupation:
From the data of Table 4, 44% and 30% of respondents’ were private job holder or wage earner respectively. While, 26% comprised the occupation as student, self – employed, un-employed and farmer.
Table 4. Frequency and percent of Occupation type
|
Income |
Frequency |
Percent |
|
Student |
01 |
02 |
|
Private |
15 |
30 |
|
Self – Employed |
06 |
12 |
|
Un-Employed |
01 |
02 |
|
Wage Earner |
22 |
44 |
|
Farmer |
05 |
10 |
Gender and Nationality:
All fifty participants were male and Indian and as reflecting in below Table 5.
Table 5. Frequency and percent of Gender and Nationality
|
Frequency |
Percent |
||
|
Gender |
Male |
50 |
100 |
|
Nationality |
Indian |
50 |
100 |
Physical Disability:
As presented in Table 6, only 30% of participants were physically disable.
Table 6. Frequency and percent of Physical disability
|
|
Frequency |
Percent |
|
Yes |
15 |
30 |
|
No |
35 |
70 |
Marital Status
Maximum percent of respondents we married i.e. 64%. But, as mentioned in Table 7, rest 38% participant were unmarried and divorced.
Table 7. Frequency and percent of Marital status
|
Status |
Frequency |
Percent |
|
Married |
31 |
62 |
|
Unmarried |
17 |
34 |
|
Divorced |
02 |
04 |
Joint Family:
As provided in below Table 8, 56% were not staying in joint family and 44% were staying in joint family.
Table 8. Frequency and percent of Family type
|
|
Frequency |
Percent |
|
Yes |
22 |
44 |
|
No |
28 |
56 |
Family Size:
As tabulated in Table 9, respondents have different family size. Where 72% of participants have family size of 03-05 members. But, 12% have large family size of 08 or 09 members and two participants have very large family size (12 and 16 members).
Table 9. Frequency and percent of Family size
|
No. of Members |
Frequency |
Percent |
|
02 |
01 |
02 |
|
03 |
11 |
22 |
|
04 |
15 |
30 |
|
05 |
10 |
20 |
|
06 |
04 |
08 |
|
07 |
01 |
02 |
|
08 |
03 |
06 |
|
09 |
03 |
06 |
|
12 |
01 |
02 |
|
16 |
01 |
02 |
Status of Parent:
Both parents are alive was selected by 74% participants and both deceased was selected by 24%. While only 01 participant mentioned one parent is alive.
Table 10. Frequency and percent of Parent status
|
Status |
Frequency |
Percent |
|
Both Alive |
37 |
74 |
|
Both Deceased |
12 |
24 |
|
One Alive |
01 |
02 |
Type of House Owned:
As mentioned in Table 11, 46% respondents had mentioned house owned as Chawl while, Cottage was selected by 20%. Also, 18% had selected No house and 02% were staying at Shelter home.
Table 11. Frequency and percent of House owned
|
Type |
Frequency |
Percent |
|
Cottage |
10 |
20 |
|
Chawl |
23 |
46 |
|
No house |
09 |
18 |
|
Flat |
06 |
12 |
|
Bungalow |
01 |
02 |
|
Shelter home |
01 |
02 |
Type of Vehicle Owned:
As per the table 12, 58% participants owned two wheeler and 10% three wheeler. 32% respondents have selected no vehicle.
Table 12. Frequency and percent of Vehicle owned
|
Type |
Frequency |
Percent |
|
Two wheeler |
29 |
58 |
|
Three wheeler |
05 |
10 |
|
No vehicle |
16 |
32 |
Type of Loan:
As provided in Table 13, 56% respondents had not any loan while, other two major types of loan was Vehicle and Agriculture at 20% and 14% respectively.
Table 13. Frequency and percent of Loan type
|
Type |
Frequency |
Percent |
|
Vehicle Loan |
10 |
20 |
|
Personal Loan |
03 |
06 |
|
Agriculture Loan |
07 |
14 |
|
Home Loan |
02 |
04 |
|
No Loan |
28 |
56 |
Sole Earning Member of Family:
As presented in Table 17, only 78% of participants were sole earning member of family.
Table 14. Frequency and percent Earning member of family
|
|
Frequency |
Percent |
|
Yes |
39 |
78 |
|
No |
11 |
22 |
Participated in Number of Studies:
% of participants in less number of studies were more till seven studies except six. While, there were participants who had participated in more number of studies i.e. 08 to 20 but, such participants were only total 09 participants. Refer the Table 15 for detail distribution for number studies and respective number of participants.
Table 15. Frequency and percent of Number studies in which participated
|
No. of Studies |
Frequency |
Percent |
|
01 |
05 |
10 |
|
02 |
06 |
12 |
|
03 |
05 |
10 |
|
04 |
13 |
26 |
|
05 |
06 |
12 |
|
06 |
01 |
02 |
|
07 |
05 |
10 |
|
08 |
01 |
02 |
|
10 |
02 |
04 |
|
12 |
02 |
04 |
|
14 |
02 |
04 |
|
15 |
01 |
02 |
|
20 |
01 |
02 |
Age of First Time Participation:
From Table 16, it is clearly reflecting that first time participation age of 18 years, 20 years and 25 years had selected by 12% of participants for each age. While the participants for age of above 27 years were in range of 01-03.
Table 16. Frequency and percent of Age of first time participation
|
Age (Yrs.) |
Frequency |
Percent |
|
18 |
06 |
12 |
|
19 |
02 |
04 |
|
20 |
06 |
12 |
|
21 |
01 |
02 |
|
23 |
01 |
02 |
|
24 |
01 |
02 |
|
25 |
06 |
12 |
|
26 |
04 |
08 |
|
27 |
04 |
08 |
|
29 |
02 |
04 |
|
30 |
01 |
02 |
|
31 |
01 |
02 |
|
32 |
01 |
02 |
|
33 |
02 |
04 |
|
34 |
03 |
06 |
|
35 |
03 |
06 |
|
38 |
01 |
02 |
|
39 |
01 |
02 |
|
40 |
03 |
06 |
|
41 |
01 |
02 |
Total Sibling:
66% respondents had total siblings in range of 02-04. While, 06% had no siblings, 08% respondents had only one sibling and 20% respondent had more than 05 siblings.
Table 17. Frequency and percent of Total sibling
|
Number of Sibling |
Frequency |
Percent |
|
0 |
03 |
06 |
|
1 |
04 |
08 |
|
2 |
17 |
34 |
|
3 |
08 |
16 |
|
4 |
08 |
16 |
|
5 |
04 |
08 |
|
6 |
02 |
04 |
|
7 |
02 |
04 |
|
8 |
01 |
02 |
|
9 |
01 |
02 |
Other Family Member Participating:
From each participant’s family, more than one family member can participate in the BEPK study. So values presented in last column of below Table 18 is ‘percent of cases’. Where it is reflecting that wife of 10% respondents was participating while, 84% of participants’ family member was not participating. Also 02% participants’ son, 2% of daughter and 04% of brother was participating.
Table 18. Frequency and percent of other participating family member
|
Member Participating |
Frequency |
Percent |
|
Wife |
05 |
10.0 |
|
Son |
01 |
02.0 |
|
Daughter |
01 |
02.0 |
|
Brother |
02 |
04.0 |
|
No One |
42 |
84.0 |
Hypothesis-01
H0: There is no significant association between the Occupation and number of times participant participated.
Chi-square statistics were used to examine association between categorical variables viz.: Occupation and number of times participant participated. There was significant relationship at 5% significance level between Occupation and number of times participant participated (X2= 084.000, df = 60, p= 0.022). Hence, H0 was rejected.
Table 19. Result of Chi-Square test for Hypothesis-01
|
Particulars |
Value |
df |
Asymptotic Significance (2-sided) |
|
Pearson Chi-Square |
084.000 |
60 |
0.022* (*p value <0.05) |
|
N of Valid Cases |
50 |
|
|
Hypothesis-02
H0: There is no significant association between the Education and Age of first time participant participated.
Chi-square statistics were used to examine association between two categorical variables viz.: Education and Age of first time participant participated. There was significant relationship at 5% significance level between the Education and Age of first time participant participated (X2 = 102.446, df = 76, p= 0.023). Hence, H0 was rejected.
Table 20. Result of Chi-Square test for Hypothesis-02
|
Particulars |
Value |
df |
Asymptotic Significance (2-sided) |
|
Pearson Chi-Square |
102.446 |
76 |
0.023* (*p value <0.05) |
|
N of Valid Cases |
50 |
|
|
CONCLUSION:
From mentioned data we can conclude that participants having age range of 18-41 years, income less than one lakh and education below higher secondary are participating more compare to respective upper range.
Participants who are wage-earner or doing private job are participating more compare to student, self-employed, farmer and un-employed.
Compare to unmarried participants, married people are participating more and it may inferred that this is due to more responsibility for family.
Majority of respondents who are participating more have no home or they are living in chawl or cottage.
Respondents are not only family member who were participating but, as per this study results other family members like wife, son, daughter and brother are also participating but, percentage of such participants were less compare to participants whose family member was not participating.
Significant difference between occupation and number of times participant participated indicated that there is influence of occupation on number of times participant participate in the BEPK study.
Significant difference between education and age of first time participation directed that there is effect of education on first time participation in the BEPK study.
CONFLICT OF INTEREST:
The authors have no conflicts of interest regarding this work.
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Received on 08.11.2021 Modified on 19.11.2021
Accepted on 25.11.2021 ©A&V Publications All right reserved
Res. J. Pharmacology and Pharmacodynamics.2021;13(4):105-110.
DOI: 10.52711/2321-5836.2021.00033