survey of health adult human participants of early phase bioequivalence pharmacokinetic endpoint study in gujarat state of india

Abstract

Aim: Study of healthy adult human participants of early phase bioequivalence pharmacokinetic endpoint study in Gujarat state of India for their demographics, participation details, awareness level, objectives of participation, factors considered for participation, overall participation experience, other people s reasons for not to participate, reasons to withdraw and not to withdraw the consent even willing to withdraw. newlineMethod: Newly developed questionnaire was validated by face validity, content validity and pilot study with 50 participants. After having ethics committee approval, validated questionnaire was administered in English, Gujarati and Hindi languages in 1250 participants after taking their written consent to participate. Filled questionnaire of 583 (i.e., response rate of 46.64%) participants were considered for statistical analysis after coding and comparing data by double entry in Microsoft Excel 2013. Statistical analysis was done with SPSS Version: 25.0 and SAS Version: 9.4 for windows for descriptive and inferential statistics. newlineResults: Developed questionnaire passed validity tests. Out of 583 Indian participants, 81.8% participants were from age range of 26 to 41 years. All participants had income up to Rupees 4,50,000. Only 14.2% participants had education of graduation and post-graduation. 69.6% participants were holding private job or wage-earner. Around 75% participants were married and staying in chawl or cottage. 45.5% of participants had started participation at ages like 20 years, 26 years and 30 years. 82.2% of participants had participated more than once and 95.2% participants were agreeing that Government of India should allow to conduct such studies. Awareness level of participants was not high or low but was average. Top rated objective for participation was to get money and factor considered for participation was relation with screening team of CRO . Overall experience is good was rated top among other experience for overall participation experience. Their family restriction