Abstract Type: Poster Abstract

Submit Date: April 10, 2018.

Event Title: DIA China 2018 Call for Student Posters Abstracts.

POSTER ABSTRACT:

Abstract Title: Public Knowledge and Perception of Clinical Research in Kolhapur,

a city in Western India.

Interest Area: Patient Engagement.

Objectives: Of everyone involved in clinical research [CR], the patient is the most
important. Very few studies in developing countries have focused on the patient’s
view about CR. This study was carried out to assess the extent of awareness and
understanding about CR amongst lay people of Kolhapur city.

Methods: A cross sectional study was conducted at the institution. A validated,

48-item questionnaire with nine themes [after consent] was administered.
Descriptive and inferential statistics were used to describe the data.

Results: Of the 467 participants approached, 378 [80.94%] consented. There were
241 [63.75%] males and 137 [36.25%] females. Two hundred and nineteen
[57.93%] were from upper middle class and 238 [63%] were at least high school
educated. Themes explored were awareness, willingness to participate,
autonomy, adequacy of information given, confidentiality, safety, voluntariness,
payment for participation and public engagement. Impact of age, education,
socio-economic class [SEC] and gender on the themes was analyzed. One hundred
and seventy-five [46.29%] had heard about CR while 158 [41.79%] were willing to
participate. Nearly, half [180, 47.61%] needed permission to participate. One
hundred and ninety four [51.33%] believed that participants get adequate
information. Most [311, 83%] felt that confidentiality is vital. A majority [317,
83.86%] said that participation was voluntary. Just 29 [7.67%] mentioned
coercion. Three quarters [285, 75.39%] endorsed public engagement. SEC
impacted awareness, willingness, autonomy and understanding of confidentiality
[p <0.05]. Age impacted awareness [reduction with rising age], willingness
[reluctance to participate with rising age], adequacy of information [Older people
relative to younger felt adequate information was given], and confidentiality
[Older age less concerned with confidentiality]. With rise in education, willingness
rose, and need for permission as also belief of disclosure of adequate information
dropped.

Conclusion: A little over half of participants surveyed were aware about CR. Age,
gender; socioeconomic class and education were identified as the key variables
that impacted perception and willingness to participate in CR. Women were seen
to have less autonomy relative to men for participation. Knowledge of and
awareness about CR directly impacts the informed consent process. Given that
only half the participants studied were aware of CR, investigators have a greater
responsibility to ensure adequacy of the informed consent process, an ethical
imperative. Given that three quarters endorse public engagement in CR, true
collaboration can be achieved in countries like India, with greater health – related
education of the lay public and empower them to make truly informed decisions.