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首页> 外文期刊>British Journal of Clinical Pharmacology >The impact of parallel regulatory–health technology assessment scientific advice on clinical development. Assessing the uptake of regulatory and health technology assessment recommendations
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The impact of parallel regulatory–health technology assessment scientific advice on clinical development. Assessing the uptake of regulatory and health technology assessment recommendations

机译：并行监管卫生技术评估科学建议对临床发展的影响。 评估监管和健康技术评估建议的吸收

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摘要

Aims The parallel regulatory–health technology assessment scientific advice (PSA) procedure allows manufacturers to receive simultaneous feedback from both EU regulators and health technology assessment (HTA) bodies on development plans for new medicines. The primary objective of the present study is to investigate whether PSA is integrated in the clinical development programmes for which advice was sought. Methods Contents of PSA provided by regulators and HTA bodies for each procedure between 2010 and 2015 were analysed. The development of all clinical studies for which PSA had been sought was tracked using three different databases. The rate of uptake of the advice provided by regulators and HTA bodies was assessed on two key variables: comparator/s and primary endpoint. Results In terms of uptake of comparator recommendations at the time of PSA in the actual development, our analysis showed that manufacturers implemented comparators to address both the needs of regulators and of at least one HTA body in 12 of 21 studies. For primary endpoints, in all included studies manufacturers addressed both the needs of the regulators and at least one HTA body. Conclusions One of the key findings of this analysis is that manufacturers tend to implement changes to the development programme based on both regulatory and HTA advice with regards to the choice of primary endpoint and comparator. It also confirms the challenging choice of the study comparator, for which manufacturers seem to be more inclined to satisfy the regulatory advice. Continuous research efforts in this area are of paramount importance from a public health perspective.
机译：AIMS并行监管 - 健康技术评估科学建议（PSA）程序允许制造商从欧盟监管机构和健康技术评估（HTA）机构就新药的发展计划接受同时反馈。本研究的主要目的是调查PSA是否集成在寻求建议的临床发展方案中。方法分析了2010年至2015年间每项程序的调节剂和HTA体提供的PSA的含量。使用三个不同的数据库跟踪所寻求PSA的所有临床研究的开发。在两个关键变量中评估监管机构和HTA机构提供的建议的采样率：比较器/ s和初级终点。在PSA在实际发展时摄取比较器建议的影响结果表明，我们的分析显示制造商实施了比较器，以解决调节因素的需求和至少21项研究中的至少一个HTA体。对于主要终点，在所有包括的研究中，制造商涉及调节剂和至少一个HTA体的需求。结论该分析的关键结果之一是，制造商倾向于根据监管和HTA建议在主要终点和比较者的选择方面对开发计划进行更改。它还证实了研究比较者的具有挑战性的选择，其中制造商似乎更倾向于满足监管建议。在公共卫生角度来看，这一领域的不断研究努力至关重要。

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    Tafuri Giovanni; Lucas Inês; Estev?o Steve; Moseley Jane; dAndon Anne; Bruehl Hannah; Gajraj Elangovan; Garcia Sonia; Hedberg Niklas; Massari Marco; Molina Andrea; Obach Mercè; Osipenko Leeza; Petavy Frank; Petschulies Marco; Pontes Caridad; Russo Pierluigi; Schiel Anja; Van de Casteele Marc; Zebedin‐Brandl Eva‐Maria; Rasi Guido; Vamvakas Spiros;

  • 作者单位

    Italian Medicines Agency (AIFA)Via del Tritone 181‐00187 Rome Italy;

    European Medicines Agency (EMA)30 Churchill Place London E14 5EU United Kingdom;

    The National Health Care Institute (ZIN)4 Eekholt Diemen 1112 XH The Netherlands;

    European Medicines Agency (EMA)30 Churchill Place London E14 5EU United Kingdom;

    Haute Autorité de Santé (HAS)5 Avenue du Stade de France 93210 Saint‐Denis France;

    The Federal Joint Committee (G‐BA)Wegelystr. 8 D‐10623 Berlin Germany;

    The National Institute for Health and Care Excellence (NICE)10 Spring Gardens London SW1A 2BU;

    Spanish Agency of Medicines and Medical Devices (AEMPS)Calle Campezo 1 Edificio 8 28022 Madrid;

    Dental and Pharmaceutical Benefits Agency (TLV)Fleminggatan 18 104 22 Stockholm Sweden;

    Italian Medicines Agency (AIFA)Via del Tritone 181‐00187 Rome Italy;

    Servei Català de la Salut (CatSalut)Travessera de les Corts 131‐159 Edifici Olímpia 08028;

    Servei Català de la Salut (CatSalut)Travessera de les Corts 131‐159 Edifici Olímpia 08028;

    The National Institute for Health and Care Excellence (NICE)10 Spring Gardens London SW1A 2BU;

    European Medicines Agency (EMA)30 Churchill Place London E14 5EU United Kingdom;

    The Federal Joint Committee (G‐BA)Wegelystr. 8 D‐10623 Berlin Germany;

    Servei Català de la Salut (CatSalut)Travessera de les Corts 131‐159 Edifici Olímpia 08028;

    Italian Medicines Agency (AIFA)Via del Tritone 181‐00187 Rome Italy;

    Norwegian Medicines Agency (NoMA)Str?msveien 96 0663 Oslo Norway;

    National Institute for Health and Disability Insurance (INAMI‐RIZIV)Avenue de Tervueren 211 1150;

    Main Association of Austrian Social Security Institutions (HVB)Kundmanngasse 21 A‐1031 Vienna;

    European Medicines Agency (EMA)30 Churchill Place London E14 5EU United Kingdom;

    European Medicines Agency (EMA)30 Churchill Place London E14 5EU United Kingdom;

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  • 原文格式 PDF
  • 正文语种 eng
  • 中图分类 药理学;
  • 关键词

    clinical development; European Medicines Agency; health technology assessment; HTA bodies; parallel scientific advice; regulatory;

    机译：临床发展;欧洲药物局;健康技术评估;HTA机构;并行科学建议;监管;

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