{"id":7003,"date":"2026-04-01T11:17:09","date_gmt":"2026-04-01T09:17:09","guid":{"rendered":"https:\/\/mediconomics.com\/?post_type=glossary&p=7003"},"modified":"2026-07-13T19:09:53","modified_gmt":"2026-07-13T17:09:53","slug":"scientific-advice","status":"publish","type":"glossary","link":"https:\/\/mediconomics.com\/en\/glossar\/scientific-advice\/","title":{"rendered":"Scientific Advice"},"content":{"rendered":"

Scientific Advice<\/strong> refers to the formalised scientific consultation provided by medicinal product authorities, in particular the European Medicines Agency (EMA) or national authorities, on central questions of drug development. The aim is to align development programmes at an early stage so that study design, endpoints, statistics, quality requirements and authorisation strategy are regulatorily acceptable, minimising later follow-up requests.<\/p>\n

Particularly in the case of innovative therapies, small patient populations or accelerated approval pathways, an early dialogue can be decisive. Scientific Advice helps to avoid flawed developments that only become apparent late, such as unsuitable endpoints, inadequate comparator therapies or insufficient evidence of clinical relevance. At the same time, Advice creates a documented reference framework to justify internal decisions to management and investors in a traceable manner.<\/p>\n

Objectives and typical questions<\/h2>\n

Scientific Advice is typically sought before key milestones: before Phase II\/III designs, when choosing primary endpoints, when planning paediatric programmes, or when innovative methods (e.g. adaptive designs, surrogate endpoints) are used. Questions concerning comparator therapy, the selection of patient populations, dose-finding, or the extrapolation of data (e.g. from real-world evidence) are also common topics.<\/p>\n

In terms of content, the spectrum ranges from endpoint and control group questions through missing data strategies to requirements for safety data. For companies, the benefit is strategic and operational: clarity about expectations lowers development risks, protects timelines and improves the quality of subsequent authorisation documentation, for example for a Marketing Authorisation Application. In addition, Advice can help reconcile study feasibility with regulatory expectations, for example regarding recruitment rates, follow-up duration, endpoint measurement or the selection of investigational sites.<\/p>\n

Formats in the EU: EMA, national advice and parallel advice<\/h2>\n

In the EU, the EMA offers Scientific Advice particularly in the centralised context; national authorities offer advisory services in parallel. In addition, formats such as Parallel Advice with HTA institutions exist to better harmonise regulatory requirements and reimbursement logic. The choice of format depends, among other things, on the product, the indication, the planned authorisation route and the maturity of the programme.<\/p>\n

Scientific Advice is not legally binding but carries high practical weight. Deviations from the advised path must later be justified in a traceable manner. Many organisations therefore maintain a mapping showing how individual Advice points were implemented in the protocol, the Statistical Analysis Plan and the development strategy. Consistency is particularly important in programmes with multiple regulatory interactions, in order to avoid contradictory design decisions.<\/p>\n

Process and best practices for the briefing package<\/h2>\n

An Advice procedure is structured: the sponsor submits a briefing package, formulates precise questions and provides background, existing data and planned study concepts. During the interaction, questions on clinical benefit, endpoints, safety monitoring, statistics, data management and quality aspects are discussed. The result is a written response, which serves as a reference for further programme work.<\/p>\n

    \n
  • Briefing package:<\/strong> context, existing data, planned concept, specific questions including the sponsor’s position.<\/li>\n
  • Meeting:<\/strong> discussion with experts, clarification of critical points, and, where necessary, submission of further information.<\/li>\n
  • Follow-up:<\/strong> documentation, internal implementation, change control and derivation of next steps.<\/li>\n<\/ul>\n

    Best practice is to prepare each question as a decision template: which option does the sponsor prefer, what alternatives exist, and what consequences would they have for feasibility, timeline and the strength of evidence? This increases the likelihood that the feedback is operationally usable rather than merely generic guidance.<\/p>\n

    Link to GCP, data quality and operational feasibility<\/h2>\n

    Scientific Advice concerns not only clinical questions but also feasibility under Good Clinical Practice. This includes robust protocols, valid endpoints, a consistent monitoring concept and traceable data flows. Particularly in complex trials, topics such as risk-based monitoring, electronic data capture, audit trail logic and data integrity are relevant, as they influence the later acceptance of the evidence.<\/p>\n

    For sponsors and CROs, it is therefore advisable to consider operational feasibility already during Advice: recruitability, study centres, data management capacity and the planned analysis must fit together. If, for example, a surrogate endpoint is discussed, it should be clarified in parallel whether the measurement can be standardised, whether central evaluation is required, and how quality assurance is ensured across country borders. Equally relevant is whether endpoints can be reliably captured in routine care, should supplementary real-world evidence be planned.<\/p>\n

    A further practical aspect is governance: who decides on protocol changes? How are deviations from the Advice documented? And how is it ensured that downstream documents (data management plan, monitoring plan, training materials) are consistently updated? Without this overarching structure, inconsistencies arise that later become apparent in audits or the authorisation procedure. Good preparation can also prevent later regulatory questions from leading to costly protocol amendments or delays.<\/p>\n

    Regulatory references (selection)<\/h2>\n
      \n
    • EMA Scientific Advice procedure and associated guidance documents (procedural requirements).<\/li>\n
    • ICH E6(R3) (Good Clinical Practice) and ICH E9 (statistics) as methodological framework.<\/li>\n
    • Regulation (EU) No 536\/2014 (clinical trials) as context for the conduct of trials in the EU.<\/li>\n<\/ul>\n

      FAQ<\/h2>\n

      Is Scientific Advice binding?<\/h3>\n

      No. Scientific Advice is not legally binding but is regarded as an important point of orientation in later assessments. Deviations should be well justified and documented.<\/p>\n

      When should Scientific Advice be sought?<\/h3>\n

      Before key decisions in the development programme, typically before Phase II\/III trials, in the case of innovative endpoints, or when special authorisation pathways are being considered.<\/p>\n

      Can Scientific Advice also be used for medical devices?<\/h3>\n

      Different procedures apply to medical devices than to medicinal products. However, scientific advisory options do exist, for example via expert panels or national bodies, with requirements more closely aligned to the MDR\/IVDR and clinical evaluation.<\/p>\n","protected":false},"excerpt":{"rendered":"

      Scientific Advice refers to the formalised scientific consultation provided by medicinal product authorities, in particular the European Medicines Agency (EMA) or national authorities, on central questions of drug development. The aim is to align development programmes at an early stage so that study design, endpoints, statistics, quality requirements and authorisation strategy are regulatorily acceptable, minimising […]<\/p>\n","protected":false},"author":10,"featured_media":0,"parent":0,"template":"","meta":{"_acf_changed":false,"site-sidebar-layout":"default","site-content-layout":"","ast-site-content-layout":"default","site-content-style":"default","site-sidebar-style":"default","ast-global-header-display":"","ast-banner-title-visibility":"","ast-main-header-display":"","ast-hfb-above-header-display":"","ast-hfb-below-header-display":"","ast-hfb-mobile-header-display":"","site-post-title":"","ast-breadcrumbs-content":"","ast-featured-img":"","footer-sml-layout":"","ast-disable-related-posts":"","theme-transparent-header-meta":"","adv-header-id-meta":"","stick-header-meta":"","header-above-stick-meta":"","header-main-stick-meta":"","header-below-stick-meta":"","astra-migrate-meta-layouts":"set","ast-page-background-enabled":"default","ast-page-background-meta":{"desktop":{"background-color":"","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"tablet":{"background-color":"","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"mobile":{"background-color":"","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""}},"ast-content-background-meta":{"desktop":{"background-color":"var(--ast-global-color-5)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"tablet":{"background-color":"var(--ast-global-color-5)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"mobile":{"background-color":"var(--ast-global-color-5)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""}},"footnotes":""},"glossary-cat":[],"class_list":["post-7003","glossary","type-glossary","status-publish","hentry"],"acf":[],"related_terms":"","external_url":"","internal_reference_id":"","_links":{"self":[{"href":"https:\/\/mediconomics.com\/en\/wp-json\/wp\/v2\/glossary\/7003","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/mediconomics.com\/en\/wp-json\/wp\/v2\/glossary"}],"about":[{"href":"https:\/\/mediconomics.com\/en\/wp-json\/wp\/v2\/types\/glossary"}],"author":[{"embeddable":true,"href":"https:\/\/mediconomics.com\/en\/wp-json\/wp\/v2\/users\/10"}],"version-history":[{"count":1,"href":"https:\/\/mediconomics.com\/en\/wp-json\/wp\/v2\/glossary\/7003\/revisions"}],"predecessor-version":[{"id":7005,"href":"https:\/\/mediconomics.com\/en\/wp-json\/wp\/v2\/glossary\/7003\/revisions\/7005"}],"wp:attachment":[{"href":"https:\/\/mediconomics.com\/en\/wp-json\/wp\/v2\/media?parent=7003"}],"wp:term":[{"taxonomy":"glossary-cat","embeddable":true,"href":"https:\/\/mediconomics.com\/en\/wp-json\/wp\/v2\/glossary-cat?post=7003"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}