Clinical Trials in Russia Through Patients’ Eyes
Results of a multicenter study in the Russian Federation
Study: Face2Face
Clinical trials as seen by physicians
Clinical trials as seen by patients
Objective of study
Evaluate the expectations, motivation and experience of patients participating in clinical trials (CTs)
Face2Face
Multicenter cross-sectional study
Tomsk
Novokuznetsk
Khanty-Mansiysk
Saint Petersburg
Pyatigorsk
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
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
Decision-making and motivation to participate
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
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”
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”
• 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.
Su
mm
ary
Informed consent
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
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
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”
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
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
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
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”
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
• 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.
Su
mm
ary
Experience of participation in clinical trial
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
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”
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
Communications
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
• 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.
Su
mm
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• 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
• 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
• 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
• 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
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 [email protected]
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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