Abstract:
BACKGROUND:Substance abuse research can raise ethical concerns about the comprehension and decision-making capacities of participants with drug dependence. In this study, the competence and willingness to consent to research participation were examined among patients with heroin dependence. METHODS:Twenty patients with heroin dependence and 24 healthy controls were asked to indicate if they would consent to participate in a low- and high-risk study. The MacArthur Competence Assessment Tool-Clinical Research was used to assess their consent capacities. RESULTS:Patients with heroin dependence and healthy controls did not differ significantly in their consent capacity scores. However, the patterns that underlay their decisions to consent and decline to participate in the two fictional studies were significantly different. Specifically, patients with heroin dependence were more likely to consent to participate in both studies, irrespective of the ratio of benefits to risks. Further, patients with heroin dependence who agreed to participate in the research studies did not demonstrate poorer decision-making capacities than their nonconsenting counterparts. CONCLUSIONS:Although the decision-making capacities of patients with heroin dependence and healthy controls were similar, the patterns that underlay their decisions to consent or decline to participate in the studies differed significantly between the two groups. Future studies should identify the specific factors that account for these emergent group differences.
journal_name
Ther Innov Regul Scijournal_title
Therapeutic innovation & regulatory scienceauthors
Zhao L,Shi H,Ying B,Li Qdoi
10.1007/s43441-020-00127-1subject
Has Abstractpub_date
2020-09-01 00:00:00pages
1106-1111issue
5eissn
2168-4790issn
2168-4804pii
10.1007/s43441-020-00127-1journal_volume
54pub_type
杂志文章abstract:BACKGROUND:Predictions of drug sales play an important role in setting drug prices in Japan, where drug prices are highly regulated. One of 2 primary Japanese drug-pricing methodologies-the cost calculation method- refers extensively to the prediction of drug sales in establishing drug prices. Deviations from predicted...
journal_title:Therapeutic innovation & regulatory science
pub_type: 杂志文章
doi:10.1177/2168479019860123
更新日期:2019-07-16 00:00:00
abstract:BACKGROUND:The human papillomavirus (HPV) vaccine coverage is very low in Japan since the government suspended the active encouragement of the vaccination. We aimed to conduct a benefit-risk assessment of HPV vaccination and explore different consequent scenarios to identify potential improvements to the current Japane...
journal_title:Therapeutic innovation & regulatory science
pub_type: 杂志文章
doi:10.1007/s43441-020-00189-1
更新日期:2021-01-01 00:00:00
abstract:BACKGROUND:Obtaining assent from children participating in clinical trials acknowledges autonomy and developmental ability to contribute to the consent process. This critical step in pediatric drug development remains poorly understood, with significant room for improving the clarity, efficiency, and implementation of ...
journal_title:Therapeutic innovation & regulatory science
pub_type: 杂志文章
doi:10.1177/2168479017716490
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abstract:BACKGROUND:Medical information (MI) departments across pharmaceutical companies respond to medical inquiries about a company's products to healthcare providers, payors, patients, and caregivers. Responses provided are constructed to be relevant, accurate, scientifically balanced and delivered in a timely manner. Benchm...
journal_title:Therapeutic innovation & regulatory science
pub_type: 杂志文章
doi:10.1007/s43441-020-00137-z
更新日期:2020-11-01 00:00:00
abstract::The American Statistical Association and DIA have created an interdisciplinary working group of drug safety experts from academia, industry and regulatory backgrounds to explore the future direction for safety monitoring. This introduction to the series explains the background and rationale for this special section. ...
journal_title:Therapeutic innovation & regulatory science
pub_type: 杂志文章
doi:10.1177/2168479018793130
更新日期:2019-03-29 00:00:00
abstract::Efficient use of limited pharmaceutical product development resources requires integrating multiple attributes, such as efficacy, safety, pharmacology, and so on, to decide at any stage whether the development of a product should proceed aggressively or slowly or be terminated. The decision process proceeds most effec...
journal_title:Therapeutic innovation & regulatory science
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doi:10.1177/2168479014558273
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abstract:BACKGROUND:Pediatric regulations enacted in both Europe and the USA have disrupted the pharmaceutical industry, challenging business and drug development processes, and organizational structures. Over the last decade, with science and innovation evolving, industry has moved from a reactive to a proactive mode, investin...
journal_title:Therapeutic innovation & regulatory science
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doi:10.1007/s43441-020-00116-4
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journal_title:Therapeutic innovation & regulatory science
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doi:10.1177/2168479018791539
更新日期:2019-07-01 00:00:00
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journal_title:Therapeutic innovation & regulatory science
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journal_title:Therapeutic innovation & regulatory science
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journal_title:Therapeutic innovation & regulatory science
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doi:10.1007/s43441-020-00210-7
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journal_title:Therapeutic innovation & regulatory science
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doi:10.1177/2168479015587362
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journal_title:Therapeutic innovation & regulatory science
pub_type: 杂志文章
doi:10.1007/s43441-020-00206-3
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journal_title:Therapeutic innovation & regulatory science
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doi:10.1007/s43441-020-00228-x
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journal_title:Therapeutic innovation & regulatory science
pub_type: 杂志文章
doi:10.1177/2168479019849879
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abstract:BACKGROUND:Several articles showed that statistical efficiency of multi-arm randomized clinical trials (RCTs) is much better than conventional two-arm RCTs. Multi-arm RCTs attract interest mainly when the experimental treatment regimen is not optimized or several pipelines under development exist. Breast cancer is a po...
journal_title:Therapeutic innovation & regulatory science
pub_type: 杂志文章
doi:10.1007/s43441-020-00141-3
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journal_title:Therapeutic innovation & regulatory science
pub_type: 杂志文章
doi:10.1007/s43441-019-00074-6
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journal_title:Therapeutic innovation & regulatory science
pub_type: 杂志文章
doi:10.1007/s43441-019-00019-z
更新日期:2020-07-01 00:00:00
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journal_title:Therapeutic innovation & regulatory science
pub_type: 杂志文章
doi:10.1177/2168479013516774
更新日期:2014-05-01 00:00:00
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journal_title:Therapeutic innovation & regulatory science
pub_type: 杂志文章
doi:10.1177/2168479015600203
更新日期:2016-03-01 00:00:00
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journal_title:Therapeutic innovation & regulatory science
pub_type: 杂志文章
doi:10.1177/2168479014527749
更新日期:2014-11-01 00:00:00
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journal_title:Therapeutic innovation & regulatory science
pub_type: 社论
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更新日期:2018-07-01 00:00:00
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journal_title:Therapeutic innovation & regulatory science
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更新日期:2015-09-01 00:00:00
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journal_title:Therapeutic innovation & regulatory science
pub_type: 杂志文章
doi:10.1177/2168479018795854
更新日期:2019-07-01 00:00:00
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journal_title:Therapeutic innovation & regulatory science
pub_type: 杂志文章,评审
doi:10.1007/s43441-020-00215-2
更新日期:2020-09-11 00:00:00
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journal_title:Therapeutic innovation & regulatory science
pub_type: 杂志文章
doi:10.1177/2168479014547421
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journal_title:Therapeutic innovation & regulatory science
pub_type: 杂志文章
doi:10.1007/s43441-020-00133-3
更新日期:2020-09-01 00:00:00
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journal_title:Therapeutic innovation & regulatory science
pub_type: 杂志文章
doi:10.1177/2168479014563549
更新日期:2015-05-01 00:00:00
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journal_title:Therapeutic innovation & regulatory science
pub_type: 杂志文章
doi:10.1177/2168479015599811
更新日期:2015-09-01 00:00:00
abstract::Data quality is critical for clinical trials to obtain robust conclusions about drug safety and efficacy evaluation. Effective data quality evaluation has been one of the major obstacles to new drug approvals in China, which hinders innovation in drug discovery and development ultimately. To improve the data quality s...
journal_title:Therapeutic innovation & regulatory science
pub_type: 杂志文章
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更新日期:2019-03-01 00:00:00