Results of multicenter research allowed to obtain data that describe the motivation of patients to participate in clinical trials, their expectations of participation, experience and satisfaction. We believe that the findings are of significant value to the industry of clinical trials and will make participation more comfortable for patients, and will also increase the satisfaction with participating in the study.

1. Clinical Trials in Russia Through Patients’ Eyes
Results of a multicenter study in the Russian Federation
Study: Face2Face

2. Clinical trials as seen by physicians

3. Clinical trials as seen by patients

4. Objective of study
Evaluate the expectations, motivation and experience of
patients participating in clinical trials (CTs)

5. Face2Face
Multicenter cross-sectional study
Tomsk
Novokuznetsk
Khanty-Mansiysk
Saint Petersburg
Pyatigorsk

6. Population Studied
1. Under the protocol, the experience of participation in the study was
defined as the signing of informed consent and carrying out all
planned procedures of at least one visit to a clinical trial site,
accredited by the Russian Ministry of Health.
2. Patients who are currently involved in clinical trial or were involved in
the past included
70%
currently involved
30%
Involved in the past
58%
participated in CT
for the first time

7. Respondents’ characteristics
n=184
n=79; 43%
OR 1.33 (95%CI 0.93-1.90)
age 57.7±18.4 yrs
n=105; 57%
56.8±19.9 yrs 58.3±17.2 yrs
56% 39% 60% 68%
married education retired income10-20 thousand
rubles per capita

8. Decision-making and
motivation to participate

9. Decision-making
«Who did you advise with about participation in a clinical trial?»
• attending physician – 47.3%, n=88
• independently – 24.7%, n=46
• family members- 15.1%, n=28
• friends and acquaintances – 2.7%, n=2.7

10. Factors affecting the willingness to participate in a
clinical trial
Factor Average score
Monitoring by professional medical staff 3.72±1.00
Regular monitoring of my condition 3.66±0.98
Better medical care 3.62±1.00
Free treatment 3.61±1.06
An opportunity to have additional medical examinations 3.50±1.03
Obtaining new information about my disease 3.48±1.03
Having the results of the study upon its completion 3.36±1.08
To be beneficial to the society 3.20±1.03
Acquisition of new data about researched drug 3.14±1.19
Knowing that I can stop participating at any time 3.08±1.13
"What are the most important factors for you when deciding to participate in a clinical trial?". Each factor was rated on a five-point
scale, where 1 – “not important”, 2 –“Slightly important”, 3 – “Moderately important”, 4 - "very important" and 5 –“extremely
important”

11. Factors with adverse effect on willingness to
participate in a clinical trial
Factor Average score
Risk of side effects 3.01±1.27
Study of new medication 2.68±1.21
The risk of getting into placebo group 2.64±1.34
The necessity for regular visits to the hospital 2.43±1.20
Necessity of medical examinations and procedures 2.41±1.21
The necessity for regularly filling diaries and forms 2.22±1.17
"What factors were important and negatively influenced the interest in participating in the study?". Each factor was rated on a five-
point scale, where 1 – “not important”, 2 –“Slightly important”, 3 – “Moderately important”, 4 - "very important" and 5 –“extremely
important”

12. • According to the patients, when deciding to participate in CT the most
important factors for the patients were: monitoring by professionals,
regular monitoring of the condition, better medical care, and free
treatment.
• Most significant factors with adverse effect were the risk of side effects,
study of new medication and the risk of getting into the placebo group.
• When interpreting these results, it is highly probable that the findings
reflect the specificity of the clinical trial and its difference from routine
clinical practice, which is true all over the world, including the Russian
Federation. In general, the clinical trials are carried out by highly
qualified specialists in accordance with the principles of GCP, which
involves regular monitoring of the patient's condition. These
surroundings allow patients to perceive medical treatment in a clinical
trial as of better quality and gives sense of feeling safe and secure. At the
same time patients in our study were aware of the risks of participation.
They critically evaluate the likelihood of actually getting the placebo
treatment and are ready for higher organizational and clinical load in
comparison to ordinary practice.
Summary

13. Informed consent

14. Acquaintance with IC
44%
independently
36%
assistance
of researcher
20%
read
by researcher
68%
in clinic
32%
at home
5.46±11.74
hours average
3.10±9.26
together with
researcher
8.63±13.90
independently

15. Acquaintance with IC
Parameter
Researcher +
(n=96)
Researcher -
(n=76)
p/OR
Age 58.50±18.02 52.72±17.75 0,030
Gender
(female/male)
52.1%/47.9% 57.9%/42.1%
OR 0.79
(95% CI 0.43-1.45)
Education
(secondary/higher education)
43.8%/34.4% 34.7%/44.0%
OR 0.79
(95% CI 0.81-3.21)
Martial status
(married/widowed)
58.3%/22.9% 56,0%/16,0%
OR 0.73
(95% CI 0.63-1.72)
Social status
(retiree/labor worker)
67.0%/13.8% 43,4%/10,5%
OR 1.18
(95% CI 0.44-3.12)
Income
(10-15/15-20 thousand robles)
43.8%/25.0% 34.2%/30.3%
OR 1.55
(95% CI 0.73-3.29)
Currently participating in CT
(yes/no)
74.2%/25.8% 52.0%/48.0%
OR 2.65
(95% CI 1.39-5.08)
First experience in CT
(yes/no)
69.6%/30.4% 45.2%/54.8%
OR 2.77
(95% CI 1.46-5.26)
Finished at least 1 CT?
(yes/no)
92.7%/7.3% 95.4%/4.6%
OR 0.61
(95% CI 0.14-2.66)
Number of CTs participated 1.82±1.81 1.94±1.21 0.036

16. Factors affecting the willingness to participate in a
clinical trial
Factor Researcher
+
Researcher
-
р
Monitoring by professional medical staff 3.55±0.94 4.01±0.90 0.002
Regular monitoring of my condition 3.52±1.01 3.87±0.90 0.040
Better medical care 3.49±0.94 3.83±1.06 0.020
Free treatment 3.51±1.05 3.80±1.02 0.069
An opportunity to have additional medical examinations 3.48±1.02 3.67±0.99 0.224
Obtaining new information about my disease 3.36±1.05 3.65±1.00 0.094
Having the results of the study upon its completion 3.27±1.06 3.47±1.11 0.235
To be beneficial to the society 3.12±1.03 3.26±1.09 0.490
Acquisition of new data about researched drug 3.18±1.13 3.16±1.23 0.796
Knowing that I can stop participating at any time 3.02±1.11 3.28±1.12 0.154
"What are the most important factors for you when deciding to participate in a clinical trial?". Each factor was rated on a five-point
scale, where 1 – “not important”, 2 –“Slightly important”, 3 – “Moderately important”, 4 - "very important" and 5 –“extremely
important”

17. Factors with adverse effect on willingness to
participate in a clinical trial
"What factors were important and negatively influenced the interest in participating in the study?". Each factor was rated on a five-
point scale, where 1 – “not important”, 2 –“Slightly important”, 3 – “Moderately important”, 4 -" very important" and 5 –“extremely
important”
Factor Researcher
+
Researcher
-
р
Risk of side effects 2.87±1.28 3.33±1.17 0.024
Study of new medication 2.65±1.23 2.93±1.11 0.085
The risk of getting into placebo group 2.51±1.25 3.03±1.34 0.022
The necessity for regular visits to the hospital 2.34±1.16 2.66±1.24 0.108
Necessity of medical examinations and procedures 2.42±1.23 2.52±1.18 0.620
The necessity for regularly filling diaries and forms 2.13±1.17 2.46±1.18 0.061

18. Complexity of IC
«How difficult was it for you to understand the text of informed
consent?»
not
difficult
slightly
difficult
moderately
difficult
very
difficult
extremely
difficult
1.70±0.81
«After acquaintance with the informed consent how has your interest to
participate changed?»
significantly
lost interest
lost interest not changed increased extremely
increased
3.37±0.87

19. Complexity of IC
Parameter
Easy
(n=83)
Difficult
(n=92)
p/OR
Возраст 53.25±17.79 58.72±18.02 0.021
Age
61.5%/38.5% 48.9%/51.1%
OR 1.67
(95% CI 0.91-3.04)
Gender
(female/male)
37.8%/47.6% 41.3%/30.4%
OR 0.59
(95% CI 0.30-1.16)
Education
(secondary/higher education)
51.2%/17.1% 62.0%/21.7%
OR 1.05
(95% CI 0.48-2.32)
Martial status
(married/widowed)
51.2%/22.0% 60.9%/11.0%
OR 0.42
(95% CI 0.17-0.99)
Social status
(retiree/labor worker)
35.0%/31.3% 44.6%/24.0%
OR 0.60
(95% CI 0.29-1.26)
Income
(10-15/15-20 thousand robles)
60.8%/39.2% 68.1%/31.9%
OR 0.72
(95% CI 0.39-1.36)
Currently participating in CT
(yes/no)
56.3%/43.7% 60.2%/39.8%
OR 0.85
(95% CI 0.46-1.57)
First experience in CT
(yes/no)
96.9%/3.1% 91.7%/8.3%
OR 2.82
(95% CI 0.59-14.49)
Finished at least 1 CT?
(yes/no)
1.89±1.77 1.87±1.34 0.201

20. Factors affecting the willingness to participate in a
clinical trial
Factor Easy Difficult р
Monitoring by professional medical staff 3.84±0.97 3.67±0.92 0.209
Regular monitoring of my condition 3.75±1.01 3.58±0.97 0.305
Better medical care 3.77±1.02 3.52±0.97 0.108
Free treatment 3.69±1.07 3.61±1.00 0.645
An opportunity to have additional medical examinations 3.65±0.98 3.47±1.03 0.348
Obtaining new information about my disease 3.66±0.98 3.29±1.08 0.043
Having the results of the study upon its completion 3.54±1.11 3.17±1.05 0.030
To be beneficial to the society 3.28±1.03 3.10±1.07 0.321
Acquisition of new data about researched drug 3.25±1.23 3.07±1.12 0.392
Knowing that I can stop participating at any time 3.08±1.18 3.19±1.04 0.440
"What are the most important factors for you when deciding to participate in a clinical trial?". Each factor was rated on a five-point
scale, where 1 – “not important”, 2 –“Slightly important”, 3 – “Moderately important”, 4 -" very important" and 5 –“extremely
important”

21. Questions regarding IC
«How well and clear did researchers answer your questions?»
Not clear Not clear
enough
moderately
clear
very
clear
extremely
clear
3.51±0.98
• 64% had questions after acquaintance with IC
• 9% refrained to ask question
• 27% didn’t have any questions

22. • More than half of the participants asked for help when being acquainted
with IC.
• Patients seeking help from a researcher, were significantly older and had
been "less experienced" in comparison with the group that read the
consent on their own.
• In case of researcher’s assistance the acquaintance with the informed
consent was reduced threefold. In addition, after reviewing the IC
together with the researcher, respondents showed an increase in interest
in a clinical trial.
• IC text was easier in young respondents’ group. The group of
respondents who rated the IC as easy appeared to be more interested in
the final results of the study.
• Patients acquainting with IC together with researcher show better
understanding of the essence and methodology of clinical trials, are
more aware of the GCP principles, better informed about participation
risks correctly evaluate the probability of getting into the placebo group
and are ready to higher organizational and clinical load in comparison
with the actual practice.
Summary

23. Experience of
participation in clinical
trial

24. Experience of Participation in Clinical Trials
“How burdensome was it to visit the clinic?"
not
burdensome
somewhat
burdensome
moderately
burdensome
very
burdensome
extremely
burdensome
1.40±0.74
• 78% had no doubt about continuing clinical trial
• 72% pointed themselves as motivator to continue the trial
• 23% pointed researcher as motivator to continue the trial

25. Factors that motivated to continue clinical trial
Factor Average score
Permanent monitoring of my condition 3.65±1.04
My relationships with doctors/ researchers 3.56±1.02
Good response to treatment and improvement of physical condition 3.49±1.01
Free examinations and medical care 3.47±1.10
Free medications 3.43±1.19
Permanent monitoring of my condition 3.16±1.03
Unspoken promise, agreement (sense of responsibility) 2.86±1.13
"What are the important factors that motivated you to continue the clinical trial?". Each factor could be rated on a five-point scale,
where 1 – “not important”, 2 –“Slightly important”, 3 “Moderately important”, 4 -" very important" and 5 –“extremely important”

26. Meeting Expectations
«How well your expectations about clinical trial were met?»
expectations
not met
somewhat
met
moderately
met
highly
met
expectations
fully met
3.34±0.92
• 82% are willing to take part in clinical trials in the future
• 11% doubted re-engagement
• 7% are not ready to participate again
• 89% will recommend to friends and relatives to attend

27. Communications

28. Communications
• 51% have never discussed participation in CT
• 19% constantly discussed participation in CT
• 81% stay in touch with the researcher
• 69% from researcher
• 19% call from the hospital
• 12% mass media, acquaintances, other

29. • The majority of respondents evaluated visiting the clinic for CT
comfortable and had no doubt of the need to continue participation in
CT.
• The most important motivating factors were constant supervision of the
state, personal relationships with researchers, improvement of physical
condition, as well as free medical examination and medical care.
• Overall, respondents' expectations of participation were justified. Based
on the self experience, the majority of patients are willing to participate
in clinical research in the future and will recommend participation to
their friends and family.
Summary

30. • Results of the study showed that expectations, motivation and
experience of participation of patients in clinical studies on the territory
of the Russian Federation are comparable with the world's data.
• The findings illustrate a significant role of the physician in virtually all
aspects of patient participation - taking decisions on participation,
introduction to the informed consent, the motivation to continue clinical
trial. Even after the end of the study the majority of respondents are in
touch with the researcher.
• On the one hand, the study revealed specifics of the relationship between
researcher and patient in Russia, i.e. close interpersonal contact, creating
an atmosphere of trust that allows for comfortable participation
conditions, a sense of security and quality health care. On the other hand,
there is a likelihood of causing ethical conflict.
Conclusions

31. • Ivan Anatolyevich Deev, professor of Pediatrics Department,
Division, Siberian State Medical University, DMedSc
• Olga Igorevna Zvonareva, research fellow at Department of
Health, Ethics and Society, Maastricht University, Netherlands
• Olga Sergeevna Kobyakova, head of General Medical Practice
Division, Siberian State Medical University, DMedSc, Professor
• Evgeny Sergeevich Kulikov, associate professor of General
Medical Practice Division, Siberian State Medical University,
DMedSc
• Igor Dmitrievich Pimenov, resident at General Medical Practice
Division, Siberian State Medical University
The research authors / organization

32. • Golosova, Tatyana Gennadyevna – head of Pulmonology and Allergology
Department, at Novokuznetsk Municipal Children Hospital 4
• Esip, Valeria Vladimirovna – physician of 1st advisory department at Saint-
Petersburg State Budget Healthcare Institution “Consultative-Diagnostic
Center # 85
• Zhukova, Irina Alexandrovna - associate professor of Neurology and
Neurosurgery Division of Siberian State Medical University, PhD
• Zhukova, Natalia Grigoryevna – professor of Neurology and Neurosurgery
Division of Siberian State Medical University, DmedSc
• Kirillova, Natalia Alexandrovna – teaching assistant of General Medical Practice
Division of Siberian State Medical University, PhD
• Nikitina, Lidia Yuryevna – head of Therapy Division, department of
postgraduate education, PhD, associate professor at Khanty-Mansiysk State
Medical Academy
Researchers

33. • Starovoytova, Elena Alexandrovna – associate professor of General Medical
Practice Division of Siberian State Medical University, PhD
• Schastnyy, Evgeny Dmitrievich – Head of Affective States Department at
Mental Health RI in Tomsk, DmedSc
• Fedorova, Olga Sergeevna – professor of Faculty Pediatrics Division of Siberian
State Medical University, DMedSc
• Khurkhurova, Natalia Vyacheslavovna - pulmonologist at Pulmonology
Department, Deputy Chief Doctor of Clinical and Expert Work at State
budgetary institution of healthcare of Stavropol region "City hospital #2" of
Pyatigorsk
Researchers

34. Invitation to participate
We invite to participate all interested researchers, contract research
organizations, manufacturers of medicinal products, universities in the
second part of the study Face2Face-2
What’s new:
• open questions
• questionnaire for researchers
• questionnaire for monitor / sponsor
• And much more
Research launch is expected in early 2017
Registration: https://goo.gl/forms/FJF15Ryk2o7fmDA43
Contact information:
Evgeniy Sergeevich Kulikov
+7 906 950 2882 (Telegram, WhatsApp, Viber)
skype: evgenyskulikov
evgeny.s.kulikov@gmail.com

35. Publications
• Zvonareva O.I., Kulikov E.S., Deev I.A., Kobyakova O.S., Fedorova O.S.,
Kirillova N.A., Starovoytova E.A., Zhukova N.G., Zhukova I.A., Esip V.V.,
Schastnyy E.D., Khurkhurova N.V., Nikitina L.Y., Golosova T.S., Pimenov
I.D., Netaeva M.A., Fedosenko S.V. Role of Informed Consent in a
Decision-making on Participation in The Clinical Trial: Multicenter
study in Russia “Face to Face”. Bulletin of Siberian Medicine.
2016;15(4):40-51. DOI:10.20538/1682-0363-2016-4-40-51
http://bulletin.tomsk.ru/jour/article/view/663/595
• Kulikov E.S., Deev I.A., Kobyakova O.S., Zvonareva O.I., Fedorova O.S.,
Kirillova N.A., Starovoytova E.A., Zhukova N.G., Zhukova I.A., Esip V.V.,
Schastnyy E.D., Khurkhurova N.V., Nikitina L.Y., Golosova T.S., Pimenov
I.D., Netaeva M.A., Fedosenko S.V. Clinical Trials in Russia Through
Patients’ Eyes: Motivation, Expectations, and Perceptions . Clinical
Medicine (Klinicheskaya Meditsina). 2017

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