Volume 40,
Issue 12,
2019
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SYMPOSIUM:第42回日本高血圧学会総会
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シンポジウム1
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Source:
Therapeutic Research 40巻12号, 939-943 (2019);
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原著
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Source:
Therapeutic Research 40巻12号, 947-959 (2019);
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Background:Tiotropium soft mist inhaler(Spiriva® Respimat®;Tio‒R)is the first long‒acting muscarinic antagonist approved in Japan for the treatment of persistent asthma of all severities. Objective:To investigate the safety and effectiveness of Tio‒R in patients with mild‒to‒moderate persistent asthma under general clinical practice.Method:This post‒marketing surveillance(NCT03188120)was a 12‒week non‒interventional observational study. Patients who received Tio‒R for the first time for treatment of mild‒to‒moderate persistent asthma on top of at least ICS maintenance therapy were enrolled. Primary outcomes were the absolute and relative frequencies of patients with adverse drug reactions(ADRs)over a 12‒week period. The secondary outcome was the change from baseline in asthma control status at Week 12;further outcomes included Asthma Control Questionnaire‒6(ACQ‒6)score at Week 12 etc. Results:Of 193 patients enrolled, 180 and 159 were included in the safety and effectiveness analysis sets, respectively. Five (2.78%[5/180])patients in the safety analysis set reported ADRs, including thirst (1.67%[3/180]), dysphonia(1.11%[2/180]), and cough(0.56%[1/180]). One (0.56%)patient reported a serious adverse event(herpes zoster). Tio‒R was judged effective in 68.53%(98/143)of patients who had available data for baseline and Week 12. The mean ACQ‒6 score at Week 12 significantly improved compared to that at baseline(-0.93±0.80, mean change±standard deviation [95% confidence interval;-1.12, -0.73]). Conclusion:This survey detected no new safety concerns or precautions for use and confirmed the effectiveness of Tio‒R in patients with mild‒to‒moderate persistent asthma under general clinical practice.
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Source:
Therapeutic Research 40巻12号, 961-980 (2019);
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Patient centricity is one of the most important concept whenever we conduct clinical trials. In recent years, several publications about patient insight have been reported and referred to improve patient experience and clinical trial process in the world. We conducted the web‒based survey with patients who have experienced to participate in Japanese clinical trials to understand their insight /feeling /satisfaction /expectations and real circumstance around clinical trials. 1364 patients participate the web‒survey. 83.4% of the total was completed the clinical trials while 16.6% was dropout before completion. Total satisfaction(score 0:worst―score 10:best)of clinical trial was 35.2% for high(score:10‒8), 54.9% for middle(score:7‒4)and 9.9% for low(score:3‒0). As the advantage of the clinical trial, compensation was 50.7% and medical expense deduction was 45.6% while time commitment was 23.4% and transportation burden was 22.3% as the disadvantage. As the expectations for future clinical trials, to have personal medical record during the clinical trial was 81.4%(very helpful and helpful)and to see clinical trial outcome was 76.4%.This survey showed that there are various types of burden, needs and expectations at any stage from before to after the clinical trial. In order to make Japanese clinical trials more accessible and improve patient enrollment and retention at minimum study drop‒out, it is important to establish the work flow to continuously incorporate participants’ voice into the study improvement process and proactively support them.
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Source:
Therapeutic Research 40巻12号, 981-997 (2019);
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The purpose of this research was to understand real circumstance and patient experience about informed‒consent process in clinical trial in Japan.1364 patients participated the survey on the internet. All have experience a clinical trial in Japan. Male was 79.0% and female was 21.0%. 69.5% of the total was more than 50 years old. Satisfaction/Comprehension/Confidence of informed consent was 65% or more for very good or good while less than 5% for very bad or bad. The study staff who gave patients informed‒consent was 70.9% for your doctor and 56.6% for study coordinator. The time for informed‒consent by study staff was 65.5% for 30 min or less. The time to read informed‒consent form by themselves was 72.5% for 30 min or less. The time to consider study participation was 58.4% for 1 day or less. In terms of understanding level of each items in informed‒consent, all except three (other treatment options, treatment and compensation for adverse events, anticipated efficacy and side effect)are more than 80% for well understood or understood. However, 50.6% of the total answered there was something they would like to have more detail explanation(e.g. anticipated efficacy and side effect).This survey showed real world circumstance around informed‒consent in Japan, including patient experience. Informed‒consent process can be done with short‒time frame. Also, patients who completed the clinical trial and had better satisfaction of the trial were relatively satisfied with inform‒consent as well. This reminds that better patient experience in informed‒consent is really important for making clinical trials better.