Background: Single-arm trial (SAT) data is increasingly reviewed for drug approvals by regulators and Health Technology Assessment (HTA) bodies. Supplementary data in the form of external comparators (ECs) can be used to provide clinical context to support these drug evaluations. In this study we characterized HTAs for SAT-based submissions, the use of supplementary EC data and outcomes from HTA review.Methods: HTA Accelerator database was used to describe SAT-based HTA submissions with decisions (2011-2019).Results: A total of 433 SAT-based HTA submissions were identified between 2011 and 2019 with a 13-fold increase during this period. Around 65%(283/433) were in oncology or hem-oncology. Around 52%(226/433) of submissions contained some type of EC data, including prior clinical trials (24%, 104) and real-world data (RWD) (20%, 87), but 40%(175) contained no EC data. The overall acceptance rate for SAT-based submissions was 48% and with RWD EC data acceptance was 59%. In the latest 5year period (2015-2019), use of RWD ECs increased 22% as a proportion of submissions per year, whereas, prior trial ECs decreased (-14%) and use of no EC remained stable (-2%). Between 2015 to 2017 and 2018 to 2019, acceptance rate for RWD ECs increased by 20% (41% in 2015-2017 to 61% in 2018-2019) whereas prior trial EC use decreased by 10% and no EC submissions decreased 16%. Of 226 submissions using ECs, only 29%(66) used an adjusted indirect treatment comparison method.Conclusions: SAT-based submissions to HTA bodies are rapidly evolving in terms of composition and acceptance. Types of EC and methodological approach used are important determinants of positive outcomes.

This textbook discusses the formation of national systems of special education, foreign and domestic experience in this area, especially the organization of the educational process in the training of persons with disabilities and special educational needs, the basics of didactics of special pedagogy The textbook is addressed to students of higher and secondary educational institutions, students of faculties of advanced training and retraining, teachers, parents. It includes thematic content, test materials and tasks for independent work of students, dictionary of basic concepts and terms.

The article is devoted to ecological entrepreneurship in Russia, its essence, definition, aims, functions, history, ways of development. It also analyzes its place within modern society development, the possibility of its usage for social development stimulation, and stable state formation on its base. The author defines key parameters which influence on ecological business stabilization as a business direction, reflects links and patterns which guarantee its development. The article demonstrates potential ways of green business integration on social entrepreneurship, it underlines the peculiarities of legal and statutory basis in Russian Federation, describes its defining aspects. The author suggests a series of changes for the legal term of ecological entrepreneurship in order to deepen and detail its notion and meaning within statutory framework. The article describes the past and the actual and the hypothetic future stage of green business in Russia. The author cites analytics of public environmental awareness, its influence on ecological situation and potential effect on companies’ performance. The material shows the difference of essence and role of ecological entrepreneurship for legal and private persons. It also presents the propose of separation of conceptual framework of the notions “ecological” and “green”, it summarizes the reasonability of the implementation of both terms into the legal and statutory frameworks, states the necessity of new business assessment development in this context. In the final part of the article the author carries out a comparative analysis of the green law and green business development stages in the USA, Germany and Russia.

were screened and information on the data source and the way the data was used in the submission were extracted. Comments by the evidence review group (ERG) and committee were also extracted and reviewed. All data extraction was performed by two independent reviewers and all decisions were reached by consensus with an additional third reviewer. Results: A total of 52 NICE TAs were identified, 47 used the GPRD/CPRD database, 10 used the THIN database and 3 used the QResearch databases. Data from primary care databases were used to support arguments regarding clinical need and current treatment in 33 NICE TAs while 36 were used to inform input parameters for economic models. The databases were sometimes used for more than one purpose. The data from the three data sources were generally well received by the ERGs/committees. Criticisms of the data typically occurred where the results had been repurposed from a published study or had not been applied appropriately. Conclusions: The potential of UK primary care databases in NICE submissions is increasingly being realised, particularly in informing the parameters of economic models. Purpose conducted studies are less likely to receive criticism from ERGs/committees, particularly when providing clinical input into cost effectiveness models.

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