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 Japanese immunization program. METHODS:To calculate social benefit-risk of HPV vaccine, we used the Markov model to represent the natural history of HPV and adverse events (AEs) using disability-adjusted life year (DALY) as the outcome. Benefits and risks were calculated as the sum of negative and positive outcomes corresponding to all preventable diseases and AEs associated with HPV vaccination, respectively. The benefit-risk balance in 2050 was estimated using published data. RESULTS:Our model was confirmed by published cervical cancer incidence and mortality rates. The benefit-risk balance in 2050 showed that the most effective scenario was the introduction of 9-valent HPV vaccine targeting female individuals aged 10-29 years for routine vaccination starting in 2020, although there is possibility of increased risks of AEs for the vaccinated age group post resumption of recommendations. CONCLUSION:Our benefit-risk assessment of HPV vaccine helped estimate various scenarios pertaining to HPV vaccination and identify the best strategy regarding HPV vaccination. This benefit-risk assessment approach may be used for other vaccines and vaccination programs.
journal_name
Ther Innov Regul Scijournal_title
Therapeutic innovation & regulatory scienceauthors
Matsumoto T,Matsumaru N,Scuffham P,Neels P,Tsukamoto Kdoi
10.1007/s43441-020-00189-1subject
Has Abstractpub_date
2021-01-01 00:00:00pages
48-55issue
1eissn
2168-4790issn
2168-4804pii
10.1007/s43441-020-00189-1journal_volume
55pub_type
杂志文章abstract:BACKGROUND:In the breakthrough therapy designation (BTD) and Sakigake designation programs, rolling submission and close communication between applicants and regulatory authorities enable the timely access of patients to innovative medicines. However, challenges in the quality development, including chemistry, manufact...
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
abstract::The authors consider a statistically valid method that has little concern caused by down weighting in stage 2 or slight loss in efficiency and possibly improves power performance for a trial design that allows for adaptation of statistical information. In addition to the need for a priori sound data-based planning tha...
journal_title:Therapeutic innovation & regulatory science
pub_type: 杂志文章
doi:10.1177/2168479013513891
更新日期:2014-01-01 00:00:00
abstract:BACKGROUND:(1) To assess the differing viewpoints of actual and potential adult clinical trial participants in 5 age cohorts, (2) identify misperceptions and opportunities to reduce unnecessary burdens on volunteers, and (3) provide age-specific feedback to study sponsors on their current engagement efforts. METHODS:B...
journal_title:Therapeutic innovation & regulatory science
pub_type: 杂志文章
doi:10.1007/s43441-019-00033-1
更新日期:2020-01-01 00:00:00
abstract:BACKGROUND:The pace of innovation, the creative engine of the pharmaceutical industry, has been variably described as stagnant, stable, or accelerating depending on the metric used for assessment or the quality of evidence. If the predominant perception holds that the speed of innovation is sluggish, pressure for chang...
journal_title:Therapeutic innovation & regulatory science
pub_type: 杂志文章
doi:10.1007/s43441-020-00210-7
更新日期:2020-08-31 00:00:00
abstract:BACKGROUND:The number of original and supplemental ANDAs, BLAs, NDAs, and Biosimilars FDA drug/biologic approvals (Approvals) has risen dramatically in the recent years, incidentally, so has the number of issued FDA guidances (Guidances). It is hypothesized that if the structures of the two timeseries are similar and/o...
journal_title:Therapeutic innovation & regulatory science
pub_type: 杂志文章
doi:10.1007/s43441-020-00123-5
更新日期:2020-09-01 00:00:00
abstract:BACKGROUND:According to 21 Code of Federal Regulation (CFR) Part 211, Over-the-Counter (OTC) drug manufacturers must establish and follow current good manufacturing practices (cGMP) to produce quality products while meeting regulatory standards. The warning letters issued by the U.S. Food and Drug Administration (FDA) ...
journal_title:Therapeutic innovation & regulatory science
pub_type: 杂志文章
doi:10.1007/s43441-020-00231-2
更新日期:2020-10-23 00:00:00
abstract::Quality and safety tests are required for regulatory approval of drugs and pharmaceuticals in the country to guarantee minimum safety standards, and most of these tests include animal usage. In the case of biological medicines, these safety and quality tests have to be performed on a batch-to-batch basis and require a...
journal_title:Therapeutic innovation & regulatory science
pub_type: 杂志文章
doi:10.1177/2168479015572371
更新日期:2015-09-01 00:00:00
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
pub_type: 杂志文章
doi:10.1007/s43441-020-00116-4
更新日期:2020-09-01 00:00:00
abstract:BACKGROUND:This study compared the timing, regulatory marketing authorization decisions, and the final labeling for products submitted to Swissmedic to those submitted to European Medicines Agency (EMA) and the US Food & Drug Administration (FDA). METHODS:The Centre for Innovation in Regulatory Science (CIRS) conducte...
journal_title:Therapeutic innovation & regulatory science
pub_type: 杂志文章
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更新日期:2016-11-01 00:00:00
abstract:BACKGROUND:A new incentive program, "Premium Rewards for the Promotion of Innovative Drug Discovery and Resolution of Off-Label Use, etc," was introduced in Japan in 2010 and subsequently applied in 2010, 2012, and 2014. In our previous study, we reported statistical evidence regarding the attributes of drugs for which...
journal_title:Therapeutic innovation & regulatory science
pub_type: 杂志文章
doi:10.1177/2168479015600205
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journal_title:Therapeutic innovation & regulatory science
pub_type: 杂志文章
doi:10.1177/2168479018778528
更新日期:2019-03-01 00:00:00
abstract::Large electronic health care databases can be used to evaluate the effectiveness of regulatory action. Designing and interpreting such studies can be challenging. We demonstrate using case studies on modafinil, benzodiazepines, dosulepin, and piroxicam that measuring the impact of regulatory action is possible and can...
journal_title:Therapeutic innovation & regulatory science
pub_type: 杂志文章
doi:10.1177/2168479015570333
更新日期:2015-07-01 00:00:00
abstract::The Tufts Center for the Study of Drug Development and Medidata Solutions Inc analyzed data from 9737 protocols and 130,601 investigative site contracts associated with these protocols to derive updated benchmarks characterizing protocol complexity. The results of the study indicate that protocol design complexity con...
journal_title:Therapeutic innovation & regulatory science
pub_type: 杂志文章
doi:10.1177/2168479017713039
更新日期:2018-01-01 00:00:00
abstract::The U.S. and Japan have preapproval access systems for patients who have exhausted approved treatment options. We compare the systems of both countries and discuss some ethical concerns surrounding non-trial access to investigational drugs. Notable points of comparison of the two countries' systems include cost of non...
journal_title:Therapeutic innovation & regulatory science
pub_type: 杂志文章
doi:10.1007/s43441-020-00228-x
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abstract::Meta-analyses are increasingly influencing clinical practice, but significant methodological flaws have been reported. The purpose of this study was to evaluate the quality of search strategies utilized by anti-infective meta-analyses. The Embase database was searched for meta-analyses evaluating anti-infective drug t...
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
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
更新日期:2015-03-01 00:00:00
abstract::The DIA Study Endpoints Community Working Group on Mobile Sensor Technology (MST) series addresses considerations that may be useful for selecting MST for use in a clinical trial. This article describes considerations regarding the selection of MST for clinical trials including expectations around technology specifica...
journal_title:Therapeutic innovation & regulatory science
pub_type: 杂志文章
doi:10.1007/s43441-020-00188-2
更新日期:2021-01-01 00:00:00
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journal_title:Therapeutic innovation & regulatory science
pub_type: 杂志文章
doi:10.1177/2168479015577868
更新日期:2015-09-01 00:00:00
abstract:BACKGROUND:Formal incorporation of patients' perspectives is becoming increasingly important in medical product development and decision making. This article shares practical advice regarding how patient advocacy organizations, the pharmaceutical industry, and academic experts in stated-preference research can effectiv...
journal_title:Therapeutic innovation & regulatory science
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doi:10.1177/2168479017746404
更新日期:2018-07-01 00:00:00
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journal_title:Therapeutic innovation & regulatory science
pub_type: 杂志文章
doi:10.1177/2168479017720475
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:2014-09-01 00:00:00
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journal_title:Therapeutic innovation & regulatory science
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更新日期:2015-07-01 00:00:00
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journal_title:Therapeutic innovation & regulatory science
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doi:10.1007/s43441-019-00055-9
更新日期:2020-03-01 00:00:00
abstract::Attention deficit hyperactivity disorder (ADHD) is the most common neurobiological disorder in children, with a prevalence of ~6-7%1,2 that has remained stable for decades2. The social and economic burden associated with patients3, families, and broader systems (healthcare/educational) is substantial, with the annual ...
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:BACKGROUND:With the pharmaceutical industry's increased attention on enhancing patient experiences during their participation in clinical trials, the use of mobile nurse (MN) services to support the conduct of clinical trial assessments in the home (or in alternative locations other than in investigational sites) has b...
journal_title:Therapeutic innovation & regulatory science
pub_type: 杂志文章
doi:10.1177/2168479015625712
更新日期:2016-07-01 00:00:00
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journal_title:Therapeutic innovation & regulatory science
pub_type: 杂志文章
doi:10.1007/s43441-020-00177-5
更新日期:2020-11-01 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
更新日期:2018-01-01 00:00:00
abstract::In a global environment where health care costs are soaring, R&D efforts are flatlining. Meanwhile, payers are demanding more value for their money. In this environment, the traditional siloed drug development model is not sustainable. Yet innovations such as adaptive trial designs, real-world data collection, precisi...
journal_title:Therapeutic innovation & regulatory science
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doi:10.1177/2168479018814224
更新日期:2019-05-01 00:00:00
abstract::In 2010 Congress established a regulatory pathway for the approval of biosimilar products in the United States. FDA has embarked on developing the implementation framework for this pathway which includes creating guidance to assist biosimilar manufacturers in the development of these products. However, to date, the gu...
journal_title:Therapeutic innovation & regulatory science
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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
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更新日期:2016-09-01 00:00:00