A post-authorisation safety study, PASS for short, is a study of an authorized medicinal product with a clear safety objective. It serves to identify, characterize, or quantify a safety risk, to confirm the safety profile, or to measure the effectiveness of risk minimization measures. PASS expand post-authorization pharmacovigilance by a targeted investigation when the available routine data do not sufficiently answer a question.<\/p>\n
A PASS can investigate, for example, how frequently a rare adverse event occurs under real-world conditions, which patients are particularly at risk, or whether an additional risk minimization measure achieves its goal. The research interest is safety-related. The study relates to an already authorized medicinal product and complements the continuous evaluation of spontaneous reports, literature, and other pharmacovigilance data. Its results can influence the product information, the risk management plan, and the ongoing benefit-risk assessment.<\/p>\n
GVP Module VIII takes up the legal PASS definition of Directive 2001\/83\/EC. Not every data collection conducted post-authorization is thus automatically a PASS. The decisive factor is the pre-specified objective to answer a safety question or to measure the effectiveness of risk minimization. The study question, the design, and the analysis plan must therefore reveal what contribution the study is intended to make to characterizing the risk or protecting patients.<\/p>\n
A PASS can be imposed by a competent authority as a condition of the marketing authorization or later within the framework of pharmacovigilance. Such imposed studies are bound to specific regulatory requirements, approval, and reporting pathways. They are reflected in the risk management plan. The background can be an important identified or potential risk, a gap in knowledge, or the necessity to robustly demonstrate the effectiveness of a risk minimization measure.<\/p>\n
In addition, a marketing authorization holder can conduct a PASS voluntarily. A voluntary study must also be scientifically justified, methodologically appropriate, and embedded in the pharmacovigilance system. Its voluntary character does not mean that safety-relevant results remain without consequence: The marketing authorization holder monitors the emerging data and evaluates their impact on the benefit-risk ratio. New information with a possible effect on this ratio must be communicated to the competent bodies immediately.<\/p>\n
A post-authorisation efficacy study, PAES, pursues an efficacy objective after authorization. It is intended to answer questions about efficacy or therapeutic benefit; a PASS, in contrast, has a safety objective. A study cannot be unambiguously classified solely because of its post-authorization timing. The primary research objective determines whether it is planned and regulatorily managed as a PASS or PAES. Safety data can be important in a PAES, but do not automatically make it a PASS.<\/p>\n
An observational study describes a study design in which treatment takes place within the framework of routine care and is not dictated by the study protocol. A non-interventional PASS can be designed as an observational study, but not every observational study is a PASS. PASS can also be interventional. “Observational study” thus primarily denotes the type of data collection, whereas “PASS” designates the safety purpose and the classification post-authorization.<\/p>\n
An interventional PASS is designed as a clinical trial; investigational treatment or study-specific procedures go beyond routine use. The requirements for clinical trials apply to them, including the relevant approval and safety processes. A non-interventional PASS, on the other hand, observes the use under conditions of routine care without dictating the prescription via the protocol. Both forms must pursue their safety objective with an appropriate design, valid data sources, and a traceable analysis.<\/p>\n
The choice of design depends on the question. For rare or late-occurring risks, large data sources or registries can be helpful; for the investigation of a specific risk minimization, detailed process and outcome data may be required. In any case, population, exposure, endpoints, comparator groups, biases, and follow-up time must be carefully planned. The study protocol and the final report must transparently justify the conclusions regarding the benefit-risk ratio.<\/p>\n
PASS link clinical research and pharmacovigilance beyond initial authorization. In operational implementation, clear interfaces to risk management, signal management, data quality, and reporting are required. A robust case definition, the appropriate recording of medicinal product exposure, and complete follow-up are particularly demanding. Results must not only be scientifically interpreted, but also checked as to whether they suggest risk minimization measures or changes to regulatory documents.<\/p>\n
Full-service CROs such as Mediconomics support the development of PASS protocols, the selection of appropriate data sources, site management for interventional studies, and data management for non-interventional studies. Further services include pharmacovigilance processes, medical coding, statistical analysis, medical writing, and the preparation of study reports. In this way, the safety question, the study design, and the regulatory embedding are connected in a consistent project workflow.<\/p>\n
Is every study post-authorization a PASS?<\/strong><\/p>\n No. A PASS requires a specific safety objective. Studies post-authorization can also address efficacy, health care, or other research questions, for example.<\/p>\n Can a PASS be interventional?<\/strong><\/p>\n Yes. PASS can be conducted interventionally or non-interventionally. The appropriate design depends on the safety question and the applicable regulatory requirements.<\/p>\n How does PASS differ from PAES?<\/strong><\/p>\n A PASS investigates safety questions. A PAES investigates questions regarding efficacy post-authorization. The distinction depends on the main objective of the study.<\/p>\n A post-authorisation safety study, PASS for short, is a study of an authorized medicinal product with a clear safety objective. It serves to identify, characterize, or quantify a safety risk, to confirm the safety profile, or to measure the effectiveness of risk minimization measures. PASS expand post-authorization pharmacovigilance by a targeted investigation when the available […]<\/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":"default","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-6656","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\/6656","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\/6656\/revisions"}],"predecessor-version":[{"id":7444,"href":"https:\/\/mediconomics.com\/en\/wp-json\/wp\/v2\/glossary\/6656\/revisions\/7444"}],"wp:attachment":[{"href":"https:\/\/mediconomics.com\/en\/wp-json\/wp\/v2\/media?parent=6656"}],"wp:term":[{"taxonomy":"glossary-cat","embeddable":true,"href":"https:\/\/mediconomics.com\/en\/wp-json\/wp\/v2\/glossary-cat?post=6656"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}Regulatory references<\/h2>\n
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