M 04: The Key Issues of the Trial Subjects’ Protection During First in Human and Bioequivalence Studies
National University of Pharmacy Ukraine
At first in human (FIH) and bioequivalence studies healthy people are trials subjects. One of the main tasks for researcher is ensuring good health protection for them. The aim of our work was to formulate key issues of volunteers’ protection and analyze their opinion about maintaining these issues.
Materials of the research were 3 surveys which included 3 questionnaires of 135 volunteers aged 18-45 years who participated in more than 1 CT and was involved in CT and BE studies during years 2014-2015 at Clinical and Diagnostics Center of National university of pharmacy.
According to FDA and EMA guidelines; ICH GCP, Oviedo and CIOMS conventions the informed consent (IC) signing and health insurance are the most important aspects of trial subjects’ protection. These aspects are mandatory requirements controlled by authorities. IC contains many specialized medical information which is hard to volunteers understanding. Special feature of clinical trials (CT) in Ukraine is obligatory HIV-test for volunteers especially in FIH studies. It’s not regulatory requirement, but required by the trials’ sponsors who justify this by repeatedly taken blood samples during FIH. So we decided to study volunteers’ awareness in the main terms that could be used in IC, their opinion in obligatory HIV-test and quality of life (QoL).
The analysis of subjects’ awareness in IC terms showed that 34% of them asked questions during reading, 91% were satisfied with answers. For evaluation of terms understanding the list of them was offered. Volunteers had to mark terms known for sure. According to the self-rating 39% of subjects know more than 90% of terms. For evaluation of the real knowledge level list of tests was offered. Tests showed that only 14% know more than 90% of terms, 11% know less than 50% of terms.
Assessment of opinion in obligatory HIV-test showed that 91% of subjects with FIH participation experience consider this test as reasonable. In survey was established that 9% of respondents don’t know about the HIV transmission through unprotected sex so they are at risk of infection this way. 73% of subjects will pass test if it’s not obligatory for participation. At the same time only 21% of people would participate in CT if one of them were HIV-positive.
The QoL evaluation showed that 90% of volunteers didn’t change their social activity during CT. 93% of respondents had positive attitude about participation in FIH. 2% of subjects were afraid of health decreasing. After the end of FIH 79% of people noted they feel the same way as before the start.
The results showed that volunteers overestimate their awareness in special medical information in the IC form. This fact needs special attention by researchers. To increase the volunteers’ safety with the help of IC trials’ sponsors should pay more attention to its preparation. To ensure a higher level of volunteers understanding of terms given in IC an additional survey by the researcher with followed explaining of unclear information; visual aids for better perception of specialized information could be used.
Analysis of the research participants’ awareness regarding issues related to HIV showed that certain percentage of volunteers don’t have sufficient information on infection pathways and find true some false public opinions regarding HIV. It is very important to understand whether it has an effect on mental health of volunteers during the HIV-test is held. Overall, most participants of CT are positive about this procedure and would like to receive an additional information on this issue in preparing, holding and obtaining test results.
Assessment of QoL in bioequivalence study at our clinical site suggested a general well-being and satisfaction by the parties of human life, which has an impact on human health. This is very important because during CT volunteers stay at clinical site from 3 to 14 days, and the same amount after the wash-out period. Indirectly this indicates a high level of work quality of clinical site staff because their work had no negative medical, mental or emotional impact on volunteers.
The presence of participants who were afraid of ill health during participation in CT, suggests the need for psychological support and extra attention from researchers to such volunteers at various stages of the study (screening, hospitalization day and etc.).
Summarizing the results, we can conclude about the need to improve healthy volunteers’ and patients’ protection involved in CT and bioequivalence studies.