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

    mm

    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

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