Evaluation methods for clinical trials of drugs in Japan which may affect ethnic differences

Author(s):  
Chikayuki Naito
2021 ◽  
Vol 39 (15_suppl) ◽  
pp. e18573-e18573
Author(s):  
Jessica Yasmine Islam ◽  
Denise Christina Vidot ◽  
Imran K Islam ◽  
Argelis Rivera ◽  
Marlene Camacho-Rivera

e18573 Background: Despite the use of clinical trials to provide gold-standard evidence of treatment and intervention effectiveness, racial/ethnic minorities are frequently underrepresented participants. Our objective was to evaluate racial/ethnic differences in knowledge and attitudes towards clinical trials among adults in the U.S. Methods: We leveraged Health Informational National Trends Survey (HINTS) data, which is a weighted, nationally representative survey of 3865 adults (≥18 years). Data were collected between February-June 2020, and included age, race/ethnicity, sex, cancer history, and comorbidities. Participants were asked questions focused on clinical trials, including their knowledge, influential factors to participate, trusted sources of information, and if they were ever invited or participated in a clinical trial. Among adults who self-reported to have heard of clinical trials (n = 2366), we used multivariable logistic regression to evaluate racial/ethnic differences in self-reported invitation and participation in clinical trials after adjustment for cancer history, age, sex, comorbidities, and insurance status. Results: Overall, the sample included 64% non-Hispanic (NH) White, 11% NH-Black, 17% Hispanic, and 5% NH-Asian respondents. Nine percent were cancer survivors. Almost 60% self-reported to at least have some knowledge about clinical trials. When asked about factors that would influence their decision to participate in clinical trials “A lot”, participants across racial groups most frequently chose “I would want to get better” and “If the standard care was not covered by my insurance.” Cancer survivors also frequently reported their decision would be influenced “A lot” or “Somewhat” if “My doctor encouraged me to participate.” NH-White (76%), NH-Black (78%), and Hispanic (77%) cancer survivors reported their trusted source of information about clinical trials was their health care provider; NH-Asian cancer survivors reported their health care provider (51%) as well as government health agencies (30%). Compared to NH-White adults, NH-Black adults were more likely to be invited to participate in a clinical trial (OR: 2.60, 95% CI: 1.53-4.43). However, compared to NH-White adults, our data suggest NH-Black adults were less likely to participate in the clinical trial (OR: 0.76, 95% CI: 0.39-1.49) although not statistically significant. Compared to NH-White adults, NH-Asian adults were less likely to participate in clinical trials (OR: 0.10, 95% CI: 0.06-0.18). Conclusions: Health care providers are a trusted source of clinical trial information. Although NH-Black adults are more likely to be invited, they are less likely to participate in a clinical trial; as well as Asian adults. Efforts to leverage insights gained on factors of influence and sources of trusted information on clinical trials should be prioritized.


2018 ◽  
pp. 1-14
Author(s):  
Kritika Joshi ◽  
Leah A. Cardwell ◽  
Sarah L. Taylor ◽  
Hossein Alinia ◽  
Steven R. Feldman

2014 ◽  
Vol 48 (5) ◽  
pp. 644-650 ◽  
Author(s):  
Takashi Ogura ◽  
Satoshi Morita ◽  
Kan Yonemori ◽  
Takahiro Nonaka ◽  
Tsutomu Urano

2006 ◽  
Vol 14 (7S_Part_27) ◽  
pp. P1437-P1437
Author(s):  
Richard E. Kennedy ◽  
Gary R. Cutter ◽  
Mackenzie E. Fowler ◽  
Lon S. Schneider

2021 ◽  
Vol 12 ◽  
Author(s):  
Mengli Xiao ◽  
Jiake Ying ◽  
Yang Zhao ◽  
Qingna Li ◽  
Yingpan Zhao ◽  
...  

Background: The successful application of randomized, double-blind placebo-controlled studies requires maximum blinding. Organoleptic properties of the placebo should be similar to the drug, making it difficult to distinguish between the two. The uniqueness of traditional Chinese medicine (TCM) preparations makes it challenging to prepare placebo. Evaluation of the TCM placebo simulation effect can determine whether the preparation of placebo can be genuinely blind in clinical trials. There is still a lack of well-established methods to evaluate TCM placebos. Hence, this study aimed to explore the evaluation methodology of TCM placebo simulation.Methods: An independent evaluation method and three comparative evaluation methods were proposed, and three dosage forms (oral liquid, capsule, and granule) were tested. The independent evaluation, in which each person was given an experimental drug or a placebo, gave an overall assessment of organoleptic properties in a blind state. We comparatively evaluated the similarity in organoleptic properties between the experimental drug and placebo. According to different distribution methods, we divided comparative evaluation methods into three. In method 1, the evaluator was given the experimental drug and placebo and was told that there must be a placebo among them. In method 2, each evaluator was randomly assigned to the combination group or two investigational drugs group. In method 3, the evaluator was assigned to a set of three coded samples, numbered by random three-digit numbers, each different, two of which were identical, and the two samples were equally frequent.Results: In the independent evaluation, there was no difference between TCM placebo and experimental drugs in a blind state at the level of p = 0.05. Even though the comparative evaluation methods enabled identification of potential differences between the two samples, methods 2 and 3 were better than method 1 in eliminating psychological factors. Also, in method 3, the completely random method combined with the blind method eliminated the subjectivity and objectivity bias and improved the experiment’s credibility compared with the previous two methods.Conclusion: Regardless of the methods that could evaluate the placebo’s simulated effect in actual clinical trials, we suggest that independent evaluation and comparative evaluation (method 3) should be combined to reflect better whether the placebo is truly blind.


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