Clinical Trials in Russia Through Patients’ Eyes (ENG)

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  • 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 57.718.4 yrs

    n=105; 57%

    56.819.9 yrs 58.317.2 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 3.721.00

    Regular monitoring of my condition 3.660.98

    Better medical care 3.621.00

    Free treatment 3.611.06

    An opportunity to have additional medical examinations 3.501.03

    Obtaining new information about my disease 3.481.03

    Having the results of the study upon its completion 3.361.08

    To be beneficial to the society 3.201.03

    Acquisition of new data about researched drug 3.141.19

    Knowing that I can stop participating at any time 3.081.13

    "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 3.011.27

    Study of new medication 2.681.21

    The risk of getting into placebo group 2.641.34

    The necessity for regular visits to the hospital 2.431.20

    Necessity of medical examinations and procedures 2.411.21

    The necessity for regularly filling diaries and forms 2.221.17

    "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

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    ary

  • Informed consent

  • Acquaintance with IC

    44% independently

    36% assistance

    of researcher

    20% read

    by researcher

    68% in clinic

    32% at home

    5.4611.74 hours average

    3.109.26 together with

    researcher

    8.6313.90 independently

  • Acquaintance with IC

    Parameter Researcher +

    (n=96)

    Researcher -

    (n=76) p/OR

    Age 58.5018.02 52.7217.75 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 1.821.81 1.941.21 0.036

  • Factors affecting the willingness to participate in a clinical trial

    Factor Researcher

    +

    Researcher

    -

    Monitoring by professional medical staff 3.550.94 4.010.90 0.002

    Regular monitoring of my condition 3.521.01 3.870.90 0.040

    Better medical care 3.490.94 3.831.06 0.020

    Free treatment 3.511.05 3.801.02 0.069

    An opportunity to have additional medical examinations 3.481.02 3.670.99 0.224

    Obtaining new information about my disease 3.361.05 3.651.00 0.094

    Having the results of the study upon its completion 3.271.06 3.471.11 0.235

    To be beneficial to the society 3.121.03 3.261.09 0.490

    Acquisition of new data about researched drug 3.181.13 3.161.23 0.796

    Knowing that I can stop participating at any time 3.021.11 3.281.12 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

    -

    Risk of side effects 2.871.28 3.331.17 0.024

    Study of new medication 2.651.23 2.931.11 0.085

    The risk of getting into placebo group 2.511.25 3.031.34 0.022

    The necessity for regular visits to the hospital 2.341.16 2.661.24 0.108

    Necessity of medical examinations and procedures 2.421.23 2.521.18 0.620

    The necessity for regularly filling diaries and forms 2.131.17 2.461.18 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

    1.700.81

    After acquaintance with the informed consent how has your interest to participate changed?

    significantly

    lost interest

    lost interest not changed increased extremely

    increased

    3.370.87

  • Complexity of IC

    Parameter Easy

    (n=83)

    Difficult

    (n=92) p/OR

    53.2517.79 58.7218.02 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) 1.891.77 1.871.34 0.201

  • Factors affecting the willingness to participate in a clinical trial

    Factor Easy Difficult

    Monitoring by professional medical staff 3.840.97 3.670.92 0.209

    Regular monitoring of my condition 3.751.01 3.580.97 0.305

    Better medical care 3.771.02 3.520.97 0.108

    Free treatment 3.691.07 3.611.00 0.645

    An opportunity to have additional medical examinations 3.650.98 3.471.03 0.348

    Obtaining new information about my disease 3.660.98 3.291.08 0.043

    Having the results of the study upon its completion 3.541.11 3.171.05 0.030

    To be beneficial to the society 3.281.03 3.101.07 0.321

    Acquisition of new data about researched drug 3.251.23 3.071.12 0.392

    Knowing that I can stop participating at any time 3.081.18 3.191.04 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

    3.510.98

    64% had questions after acquaintance with IC

    9% refrained to ask question

    27% didnt 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 researchers 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.

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  • 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

    1.400.74

    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 3.651.04

    My relationships with doctors/ researchers 3.561.02

    Good response to treatment and improvement of physical condition 3.491.01

    Free examinations and medical care 3.471.10

    Free medications 3.431.19

    Permanent monitoring of my condition 3.161.03

    Unspoken promise, agreement (sense of responsibility) 2.861.13

    "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

    3.340.92

    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

    https://creativecommons.org/licenses/by-nc-sa/4.0/

  • 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.

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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 p...