Of Perception and Awareness of Clinical Research In ID: 919302
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Slide1
A Comparative, Multi Centric, Cross-sectional Study
Of
Perception and Awareness
of
Clinical Research
In
Trial Participants and General Public of AP
Slide2INTRODUCTION
Clinical research
helps us determine
the safety and
efficacy of medications, devices, diagnostic products intended for human use.
The design and conduct of the trial is dictated by the protocol & approved by regulatory authorities
The data thus collected is scientifically analyzed to reach a valid inference
The most challenging area in Clinical Research
is
:
finding eligible and compliant subjects for willful participation
.
Slide3NEED TO CREATE AWARENESS
Important steps in
clinical
research
Public should know
Public should understand
Public should participate
Slide4Previous studies and results
Slide5What is newsworthy?
Longitudinal study of the reporting of medical
research in two British newspapers. BMJ
Current public understanding of clinical
research is poor and media coverage of
clinical research trials is often negative
Bartlett C, Sterne J, Egger M
Slide6Promoting public awareness of randomised clinical trials using the media:
the ‘Get Randomised’ campaign
There is agreement in the literature that one of the major barriers to recruitment and
enrollment
of patients in clinical trials is patients' lack of awareness about clinical trials.
Isla S Mackenzie, Li Wei, Daniel Rutherford et al
Slide7Attitudes toward clinical trials among patients and the public
Responses differed neither by subgroup nor by demographic variables.
{104 cancer pts, 84 cardiology pts, and 107 general public}
Most respondents (71%) believed that patients should serve as research subjects
Cassileth
BR,
LuskEJ
, Miller DS, Hurwitz S
Slide8Partake study
Results suggest the Indian public is aware of some key features of clinical research like
:
purpose/ value/ voluntariness and supports clinical research in general
But is unaware of other key features like:
Compensation/confidentiality/protection of human participants &
Exhibits some distrust in the conduct and reporting of clinical trials
PARTAKE Survey of Public Knowledge and Perceptions of Clinical Research in India (Delhi)
Slide9Attitudes towards clinical research amongst participants and nonparticipants.
J Intern Med
Trial participants were, as compared with
nonparticipating
respondents,
more positive
towards both participation of self and others.
Both
personal and altruistic motives
for participation were highly rated.
Primary reasons for nonparticipation were
*fear of ‘the unknown’ and/or
*unease with randomization
Madsen SM,
Mirza
MR, Holm S,
Hilsted
KL,
Kampmann
K, Riis P (Copenhagen University )
Slide10Results of Harris Interactive Survey :
1)Awareness changes attitude toward clinical research
2) Helps participant make an informed decision
3) Improves overall trust in the clinical research
Slide11Objectives of
our
study :
To determine
the areas in which there is
LACK
of perception & awareness
of clinical
trial in both groups (TP) & (NTP)
To determine the areas in which there is
GAP
of perception & awareness of clinical trial between both groups (TP) & (NTP)
To
determine ways and means for bringing about better awareness in both groups
{{TP—trial participants, NTP----non trial participants}}
Slide12Materials & Methods
Protocol was designed and an
approval from Institutional Ethics
Committee was taken
Sample size was calculated and found to be
165
in each group.
{
Assuming
70% of awareness with 95% of confidence interval (C.I), 20% relative precision with a design effect of
2}.
Designed a Questionnaire and EC approval taken
Recruitment process
discussed for TPs and NTPs
Data collection
procedure
finalised
Statistical
Analysis discussed
Slide13RESULTS
Slide14LITERACY
TP
NTP
Illiterate
9%
9%
1-12 class
61%
61%
Graduate
30%
30%
COMPARABLE GROUPS
Slide15Purpose and Source of Information about Clinical Research
Purpose
TP
NTP
Help in Research
74%
57%
Financial
Benefit
21%
32%
Others
5%
11%
Source
of Information
TP
NTP
Friends/ Relatives/ Participated subject
81%
53%
Advertisements
5%
16%
Others (Doctors etc…)
13%
28%
Slide16Awareness
TP
NTP
Medicines using today were part of clinical trials earlier
85%
60%
Clinical research an essential step for developing new treatment of diseases
86%
62%
Trials conducted globally for better treatment of diseases
88%
60%
Many people participating in clinical trials all over the world
89%
54%
Confidentiality of the participants personal information will be maintained
97%
47%
Drugs tested thoroughly for its safety before using it
97%
62%
Leaflet that comes with medicine prepared based on clinical trial results
89%
53%
Pharmaceutical companies spend billions of rupees on clinical research
91%
53%
Take years for a drug to come into market
81%
61%
Surveillance by regulatory bodies even after the drug approval
74%
42%
Awareness on Clinical Research
Slide17Awareness on Elements of Consent Form
Participation
se
with Audio-Video Consenting
TP- 56% Believe
NTP- 73% Don’t believe
TP=Trial Participants; NTP=Non-Trial Participants (General public).
Slide18Ethics Committee
TP=Trial
Participants; NTP=Non-Trial Participants (General public)
Slide19Financial transaction
TP (%)
NTP(%)
Food and transport
34
37
Reward for participation
33
41
Transport, food and reward for participation
12
-
Transport, food and others
14
-
Others
7
22
Slide20Awareness
on Risks Vs
Benefits
TP=Trial
Participants; NTP=Non-Trial Participants (General public)
Slide21Knowledge on who will be the beneficiary in Clinical
Trials
Beneficiary
TP
NTP
Participants
7%
13%
Pharmaceutical company
12%
36%
Society
70%
49%
Society and Pharmaceutical company
6%
2%
Society and participants
5%
-
Slide22Pune Vs Hyderabad study
Source of Information:
Awareness on Risks and Benefits
Need to create awareness:
Pune: 97%; Hyderabad: 81%
Hyderabad
Pune
Friends/ Relatives
/ participated subjects
81%
28%
Doctors / Clinics
13%
72%
Hyderabad
Pune
Risks
involved in clinical Research
93%
60%
Benefits
in clinical Research
95%
75%
Slide23Conclusion
According
to our survey it was concluded
that the
awareness on
clinical
research is low in
our
society especially in the areas
of:
1) elements of
consent form and consenting process,
2) Confidentiality in Clinical Research
3)
Regulatory machinery of the clinical research.
Slide24