Häufig gestellte Fragen zur Studienteilnahme

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id=asia-pacific class="tab-pane"> <dl class="countries-list">  <dt></dt> <dd> <a href="https://www.novartis.com/au-en/" target="_self">Australia | <strong>English</strong></a> </dd> <dt></dt> <dd> <a href="https://www.novartis.com/bd-en/" target="_self">Bangladesh | <strong>English</strong></a> </dd> <dt></dt> <dd> <a href="https://www.novartis.com/hk-zh/" target="_self">Hong Kong S.A.R. | <strong>繁體中文</strong></a> </dd> <dt></dt> <dd> <a href="https://www.novartis.com/in-en/" target="_self">India | <strong>English</strong></a> </dd> <dt></dt> <dd> <a href="https://www.novartis.com/id-en/" target="_self">Indonesia | <strong>English</strong></a> </dd> <dt></dt> <dd> <a href="https://www.novartis.com/jp-ja/" target="_self">Japan | <strong>日本語</strong></a> </dd> <dt></dt> <dd> <a href="https://www.novartis.com/kr-ko/" target="_self">Korea | <strong>한국어</strong></a> </dd> <dt></dt> <dd> <a href="https://www.novartis.com.cn/" target="_self">Mainland China | <strong>中文</strong></a> </dd> <dt></dt> <dd> <a href="https://www.novartis.com/my-en/" target="_self">Malaysia | <strong>English</strong></a> </dd> <dt></dt> <dd> <a href="https://www.novartis.com/pk-en/" target="_self">Pakistan | <strong>English</strong></a> </dd> <dt></dt> <dd> <a href="https://www.novartis.com/ph-en/" target="_self">Philippines | <strong>English</strong></a> </dd> <dt></dt> <dd> <a href="https://www.novartis.com/sg-en/" target="_self">Singapore | <strong>English</strong></a> </dd> <dt></dt> <dd> <a href="https://www.novartis.com/tw-zh/" target="_self">Taiwan | <strong>繁體中文</strong></a> </dd> <dt></dt> <dd> <a href="https://www.novartis.com/th-th/" target="_self">Thailand | <strong>ภาษาไทย</strong></a> </dd> </dl> </div> <div id=europe class="tab-pane active"> <dl class="countries-list">  <dt></dt> <dd> <a href="https://www.novartis.com/at-de/" target="_self" class="active">Austria | <strong>Deutsch</strong></a> </dd> <dt></dt> <dd> <a href="https://www.novartis.com/be-fr/" target="_self">Belgium | <strong>Français</strong></a> </dd> <dt></dt> <dd> <a href="https://www.novartis.com/be-nl/" target="_self">Belgium | <strong>Nederlands</strong></a> </dd> <dt></dt> <dd> <a href="https://www.novartis.com/bg-bg/" target="_self">Bulgaria | <strong>Български</strong></a> </dd> <dt></dt> <dd> <a href="https://www.novartis.com/cz-cs/" target="_self">Czech Republic | <strong>Česky</strong></a> </dd> <dt></dt> <dd> <a href="https://www.novartis.com/cz-en/" target="_self">Czech Republic | <strong>English</strong></a> </dd> <dt></dt> <dd> <a href="https://www.novartis.com/dk-da/" target="_self">Denmark | <strong>Dansk</strong></a> </dd> <dt></dt> <dd> <a href="https://www.novartis.com/ee-et/" target="_self">Estonia | <strong>Eesti</strong></a> </dd> <dt></dt> <dd> <a href="https://www.novartis.com/fi-fi/" target="_self">Finland | <strong>Suomalainen</strong></a> </dd> <dt></dt> <dd> <a href="https://www.novartis.com/fr-fr/" target="_self">France | <strong>Français</strong></a> </dd> <dt></dt> <dd> <a href="https://www.novartis.com/de-de/" target="_self">Germany | <strong>Deutsch</strong></a> </dd> <dt></dt> <dd> <a href="https://www.novartis.com/gr-el/" target="_self">Greece | <strong>Ελληνικά</strong></a> </dd> <dt></dt> <dd> <a href="https://www.novartis.com/hu-hu/" target="_self">Hungary | <strong>Magyar</strong></a> </dd> <dt></dt> <dd> <a href="https://www.novartis.com/ie-en/" target="_self">Ireland | <strong>English</strong></a> </dd> <dt></dt> <dd> <a href="https://www.novartis.com/it-it/" target="_self">Italy | <strong>Italiano</strong></a> </dd> <dt></dt> <dd> <a href="https://www.novartis.com/lv-lv/" target="_self">Latvia | <strong>Latvian</strong></a> </dd> <dt></dt> <dd> <a href="https://www.novartis.com/lt-lt/" target="_self">Lithuania | <strong>Lithuanian</strong></a> </dd> <dt></dt> <dd> <a href="https://www.novartis.com/nl-nl/" target="_self">Netherlands | <strong>Nederlands</strong></a> </dd> <dt></dt> <dd> <a href="https://www.novartis.com/no-no/" target="_self">Norway | <strong>Norsk</strong></a> </dd> <dt></dt> <dd> <a href="https://www.novartis.com/pl-pl/" target="_self">Poland | <strong>Polski</strong></a> </dd> <dt></dt> <dd> <a href="https://www.novartis.com/pt-pt/" target="_self">Portugal | <strong>Português</strong></a> </dd> <dt></dt> <dd> <a href="https://www.novartis.com/ro-ro/" target="_self">Romania | <strong>Română</strong></a> </dd> <dt></dt> <dd> <a href="https://www.novartis.com/ru-ru/" target="_self">Russia | <strong>Русский</strong></a> </dd> <dt></dt> <dd> <a href="https://www.novartis.com/rs-sr/" target="_self">Serbia | <strong>Srpski</strong></a> </dd> <dt></dt> <dd> <a href="https://www.novartis.com/sk-sk/" target="_self">Slovakia | <strong>Slovensky</strong></a> </dd> <dt></dt> <dd> <a href="https://www.novartis.com/si-sl/" target="_self">Slovenia | <strong>Slovenščina</strong></a> </dd> <dt></dt> <dd> <a href="https://www.novartis.com/si-en/" target="_self">Slovenia | <strong>English</strong></a> </dd> <dt></dt> <dd> <a href="https://www.novartis.com/es-es/" target="_self">Spain | <strong>Español</strong></a> </dd> <dt></dt> <dd> <a href="https://www.novartis.com/se-se/" target="_self">Sweden | <strong>Svenska</strong></a> </dd> <dt></dt> <dd> <a href="https://www.novartis.com/ch-de/" target="_self">Switzerland | <strong>Deutsch</strong></a> </dd> <dt></dt> <dd> <a href="https://www.novartis.com/ch-fr/" target="_self">Switzerland | <strong>Français</strong></a> </dd> <dt></dt> <dd> <a href="https://www.novartis.com/tr-tr/" target="_self">Türkiye | <strong>Türkçe</strong></a> </dd> <dt></dt> <dd> <a href="https://www.novartis.com/uk-en/" target="_self">United Kingdom | <strong>English</strong></a> </dd> </dl> </div> <div id=international class="tab-pane"> <dl class="countries-list">  <dt></dt> <dd> <a href="https://www.novartis.com/" target="_self">Global | <strong>English</strong></a> </dd> <dt></dt> <dd> <a href="https://www.novartisfoundation.org" target="_self">Novartis Foundation | <strong>English</strong></a> </dd> </dl> </div> <div id=middle-east-africa class="tab-pane"> <dl class="countries-list">  <dt></dt> <dd> <a href="https://www.novartis.com/eg-en/" target="_self">Egypt | <strong>English</strong></a> </dd> <dt></dt> <dd> <a href="https://www.novartis.com/il-he/" target="_self">Israel | <strong>עברית</strong></a> </dd> <dt></dt> <dd> <a href="https://www.novartis.com/sa-ar/" target="_self">Saudi Arabia | <strong>العربية</strong></a> </dd> <dt></dt> <dd> <a href="https://www.novartis.com/za-en/" target="_self">South Africa | <strong>English</strong></a> </dd> </dl> </div> </div> </div> </div> </div> <div id="block-polaris-languagecountryselectorformobile" data-block-plugin-id="nc_language_selector_mobile" class="block block-nc-language-selector block-nc-language-selector-mobile"> <div class="content"> <div id="block-languagecountryselectorformobile" data-block-plugin-id="novartis_language_selector_mobile" class="block block-novartis-language-selector block-novartis-language-selector-mobile block-wrapper"> <div class="language-selector-header-block-mobile language-selector-header-mobile" id="language-selector-header-block-mobile"> <div class="language-selector-name triangle-icon"> <img src="/themes/custom/polaris/patterns/images/globe.svg" alt="language-selector-globe"> <a class="site-selector-anchor-link-toggle" href="#" aria-label="Austria">Austria</a> </div> </div> <div class="language-selector-mobile"> <div class="brand-quinary-light"> <div class="heading"> <div class="h3" aria-label="Choose Location" role="heading" aria-level="3"> <span>Choose Location</span> </div> </div> <div class="tab-content-block-mobile"> <div class="region-selector-wrapper"> <div class="dropdown dropdown-select"> <button class="dropdown-toggle" type="button" id="dropdownMenuButton" data-selected-region="europe" data-bs-toggle="dropdown" aria-haspopup="true" aria-expanded="false"> <strong><strong>europe</strong></strong> </button> <div class="dropdown-menu" > <a class="dropdown-item" data-region="americas" href="#americas">Americas</a> <a class="dropdown-item" data-region="asia-pacific" href="#asia-pacific">Asia Pacific</a> <a class="dropdown-item" data-region="europe" href="#europe">Europe</a> <a class="dropdown-item" data-region="international" href="#international">International</a> <a class="dropdown-item" data-region="middle-east-africa" href="#middle-east-africa">Middle East & Africa</a> </div> </div> </div> </div> <div class="countrylist-wrapper"> <dl class="countries-list">  <dt></dt> <dd> <a href="https://www.novartis.com/ar-es/" target="_self" data-region-identifier="americas">Argentina | <strong>Español</strong></a> </dd> <dt></dt> <dd> <a href="https://www.novartis.com/au-en/" target="_self" data-region-identifier="asia-pacific">Australia | <strong>English</strong></a> </dd> <dt></dt> <dd> <a href="https://www.novartis.com/at-de/" target="_self" data-region-identifier="europe" class="active">Austria | <strong>Deutsch</strong></a> </dd> <dt></dt> <dd> <a href="https://www.novartis.com/bd-en/" target="_self" data-region-identifier="asia-pacific">Bangladesh | <strong>English</strong></a> </dd> <dt></dt> <dd> <a href="https://www.novartis.com/be-fr/" target="_self" data-region-identifier="europe">Belgium | <strong>Français</strong></a> </dd> <dt></dt> <dd> <a href="https://www.novartis.com/be-nl/" target="_self" data-region-identifier="europe">Belgium | <strong>Nederlands</strong></a> </dd> <dt></dt> <dd> <a href="https://www.novartis.com/br-pt/" target="_self" data-region-identifier="americas">Brazil | <strong>Português</strong></a> </dd> <dt></dt> <dd> <a href="https://www.novartis.com/bg-bg/" target="_self" data-region-identifier="europe">Bulgaria | <strong>Български</strong></a> </dd> <dt></dt> <dd> <a href="https://www.novartis.com/ca-en/" target="_self" data-region-identifier="americas">Canada | <strong>English</strong></a> </dd> <dt></dt> <dd> <a href="https://www.novartis.com/ca-fr/" target="_self" data-region-identifier="americas">Canada | <strong>Français</strong></a> </dd> <dt></dt> <dd> <a href="https://www.novartis.com/candean-es/" target="_self" data-region-identifier="americas">Central America | <strong>Español</strong></a> </dd> <dt></dt> <dd> <a href="https://www.novartis.com/co-es/" target="_self" data-region-identifier="americas">Colombia | <strong>Español</strong></a> </dd> <dt></dt> <dd> <a href="https://www.novartis.com/cz-cs/" target="_self" data-region-identifier="europe">Czech Republic | <strong>Česky</strong></a> </dd> <dt></dt> <dd> <a href="https://www.novartis.com/cz-en/" target="_self" data-region-identifier="europe">Czech Republic | <strong>English</strong></a> </dd> <dt></dt> <dd> <a href="https://www.novartis.com/dk-da/" target="_self" data-region-identifier="europe">Denmark | <strong>Dansk</strong></a> </dd> <dt></dt> <dd> <a href="https://www.novartis.com/eg-en/" target="_self" data-region-identifier="middle-east-africa">Egypt | <strong>English</strong></a> </dd> <dt></dt> <dd> <a href="https://www.novartis.com/ee-et/" target="_self" data-region-identifier="europe">Estonia | <strong>Eesti</strong></a> </dd> <dt></dt> <dd> <a href="https://www.novartis.com/fi-fi/" target="_self" data-region-identifier="europe">Finland | <strong>Suomalainen</strong></a> </dd> <dt></dt> <dd> <a href="https://www.novartis.com/fr-fr/" target="_self" data-region-identifier="europe">France | <strong>Français</strong></a> </dd> <dt></dt> <dd> <a href="https://www.novartis.com/de-de/" target="_self" data-region-identifier="europe">Germany | <strong>Deutsch</strong></a> </dd> <dt></dt> <dd> <a href="https://www.novartis.com/gr-el/" target="_self" data-region-identifier="europe">Greece | <strong>Ελληνικά</strong></a> </dd> <dt></dt> <dd> <a href="https://www.novartis.com/hk-zh/" target="_self" data-region-identifier="asia-pacific">Hong Kong S.A.R. | <strong>繁體中文</strong></a> </dd> <dt></dt> <dd> <a href="https://www.novartis.com/hu-hu/" target="_self" data-region-identifier="europe">Hungary | <strong>Magyar</strong></a> </dd> <dt></dt> <dd> <a href="https://www.novartis.com/in-en/" target="_self" data-region-identifier="asia-pacific">India | <strong>English</strong></a> </dd> <dt></dt> <dd> <a href="https://www.novartis.com/id-en/" target="_self" data-region-identifier="asia-pacific">Indonesia | <strong>English</strong></a> </dd> <dt></dt> <dd> <a href="https://www.novartis.com/ie-en/" target="_self" data-region-identifier="europe">Ireland | <strong>English</strong></a> </dd> <dt></dt> <dd> <a href="https://www.novartis.com/il-he/" target="_self" data-region-identifier="middle-east-africa">Israel | <strong>עברית</strong></a> </dd> <dt></dt> <dd> <a href="https://www.novartis.com/it-it/" target="_self" data-region-identifier="europe">Italy | <strong>Italiano</strong></a> </dd> <dt></dt> <dd> <a href="https://www.novartis.com/jp-ja/" target="_self" data-region-identifier="asia-pacific">Japan | <strong>日本語</strong></a> </dd> <dt></dt> <dd> <a href="https://www.novartis.com/kr-ko/" target="_self" data-region-identifier="asia-pacific">Korea | <strong>한국어</strong></a> </dd> <dt></dt> <dd> <a href="https://www.novartis.com/lv-lv/" target="_self" data-region-identifier="europe">Latvia | <strong>Latvian</strong></a> </dd> <dt></dt> <dd> <a href="https://www.novartis.com/lt-lt/" target="_self" data-region-identifier="europe">Lithuania | <strong>Lithuanian</strong></a> </dd> <dt></dt> <dd> <a href="https://www.novartis.com.cn/" target="_self" data-region-identifier="asia-pacific">Mainland China | <strong>中文</strong></a> </dd> <dt></dt> <dd> <a href="https://www.novartis.com/my-en/" target="_self" data-region-identifier="asia-pacific">Malaysia | <strong>English</strong></a> </dd> <dt></dt> <dd> <a href="https://www.novartis.com/mx-es/" target="_self" data-region-identifier="americas">Mexico | <strong>Español</strong></a> </dd> <dt></dt> <dd> <a href="https://www.novartis.com/nl-nl/" target="_self" data-region-identifier="europe">Netherlands | <strong>Nederlands</strong></a> </dd> <dt></dt> <dd> <a href="https://www.novartis.com/no-no/" target="_self" data-region-identifier="europe">Norway | <strong>Norsk</strong></a> </dd> <dt></dt> <dd> <a href="https://www.novartis.com/" target="_self" data-region-identifier="international">Global | <strong>English</strong></a> </dd> <dt></dt> <dd> <a href="https://www.novartisfoundation.org" target="_self" data-region-identifier="international">Novartis Foundation | <strong>English</strong></a> </dd> <dt></dt> <dd> <a href="https://www.novartis.com/pk-en/" target="_self" data-region-identifier="asia-pacific">Pakistan | <strong>English</strong></a> </dd> <dt></dt> <dd> <a href="https://www.novartis.com/ph-en/" target="_self" data-region-identifier="asia-pacific">Philippines | <strong>English</strong></a> </dd> <dt></dt> <dd> <a href="https://www.novartis.com/pl-pl/" target="_self" data-region-identifier="europe">Poland | <strong>Polski</strong></a> </dd> <dt></dt> <dd> <a href="https://www.novartis.com/pt-pt/" target="_self" data-region-identifier="europe">Portugal | <strong>Português</strong></a> </dd> <dt></dt> <dd> <a href="https://www.novartis.com/ro-ro/" target="_self" data-region-identifier="europe">Romania | <strong>Română</strong></a> </dd> <dt></dt> <dd> <a href="https://www.novartis.com/ru-ru/" target="_self" data-region-identifier="europe">Russia | <strong>Русский</strong></a> </dd> <dt></dt> <dd> <a href="https://www.novartis.com/sa-ar/" target="_self" data-region-identifier="middle-east-africa">Saudi Arabia | <strong>العربية</strong></a> </dd> <dt></dt> <dd> <a href="https://www.novartis.com/rs-sr/" target="_self" data-region-identifier="europe">Serbia | <strong>Srpski</strong></a> </dd> <dt></dt> <dd> <a href="https://www.novartis.com/sg-en/" target="_self" data-region-identifier="asia-pacific">Singapore | <strong>English</strong></a> </dd> <dt></dt> <dd> <a href="https://www.novartis.com/sk-sk/" target="_self" data-region-identifier="europe">Slovakia | <strong>Slovensky</strong></a> </dd> <dt></dt> <dd> <a href="https://www.novartis.com/si-sl/" target="_self" data-region-identifier="europe">Slovenia | <strong>Slovenščina</strong></a> </dd> <dt></dt> <dd> <a href="https://www.novartis.com/si-en/" target="_self" data-region-identifier="europe">Slovenia | <strong>English</strong></a> </dd> <dt></dt> <dd> <a href="https://www.novartis.com/za-en/" target="_self" data-region-identifier="middle-east-africa">South Africa | <strong>English</strong></a> </dd> <dt></dt> <dd> <a href="https://www.novartis.com/es-es/" target="_self" data-region-identifier="europe">Spain | <strong>Español</strong></a> </dd> <dt></dt> <dd> <a href="https://www.novartis.com/se-se/" target="_self" data-region-identifier="europe">Sweden | 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href="https://www.novartis.com/at-de/betroffene-angehoerige">Betroffene & Angehörige</a> </li> <li class="breadcrumb-item"> <a href="https://www.novartis.com/at-de/betroffene-angehoerige/klinische-studien">Klinische Studien</a> </li> <li class="breadcrumb-item"> <a href="https://www.novartis.com/at-de/betroffene-angehoerige/klinische-studien/haeufig-gestellte-fragen-zur-studienteilnahme">Häufig gestellte Fragen zur Studienteilnahme</a> </li> </ol> </nav> </div> </div> </div> <div id="main" class="container-fluid custom_width"> <div class="row row-offcanvas row-offcanvas-left clearfix"> <div class="container"> <div class="main-content col order-last col-md-12 column-full" id="content"> <section class="section"> <div id="block-polaris-content" data-block-plugin-id="system_main_block" class="block block-system block-system-main-block"> <div class="content"> <div about="/at-de/betroffene-angehoerige/klinische-studien/haeufig-gestellte-fragen-zur-studienteilnahme" class="node node--type-interior-page node--view-mode-full clearfix"> <header> </header> <div class="node__content clearfix"> <div class="page_content"> <div class="row content_middle"> <div class="col-sm-12 content_left_side"> <div class="field_body_txt "> <div class="field field--name-field-body field--type-entity-reference-revisions field--label-hidden field__items"> <div class="field__item"> <div class="paragraph paragraph--type--accordion paragraph--view-mode--default"> <div class="accordion_item_wrapper accordion-stripe-close"> <div class="field field--name-field-accordion-item field--type-entity-reference-revisions field--label-hidden field__items"> <div class="field__item"> <div class="paragraph paragraph--type--accordion-items paragraph--view-mode--default"> <div class="accordion "> <div class="accordion-group"> <div class="accordion-heading"> <button class="accordion-toggle accordion-title" data-bs-toggle="collapse" href="#accordion-paragraph--5921">Wer kann an klinischen Studien teilnehmen?</button> </div> <div id="accordion-paragraph--5921" class="accordion-body collapse " tabindex="0"> <div class="accordion-stripe-body "> <div class="clearfix text-formatted field field--name-field-accordion-body field--type-text-long field--label-hidden field__item"><p>Im Prüfplan von klinischen Studien sind bestimmte Ein- und Ausschlusskriterien für die Teilnahme beschrieben. Diese beziehen sich zum Beispiel auf Alter, Geschlecht, Art und Stadium der Erkrankung, die bisherige Behandlung und eventuell vorhandene zusätzliche Erkrankungen. Für manche Studien werden auch gesunde Teilnehmerinnen und Teilnehmer gesucht. Die vorherige Einnahme bestimmter Medikamente kann ebenfalls von Bedeutung sein. Diese Kriterien dienen der Sicherheit der Patientinnen und Patienten sowie der Richtigkeit der Ergebnisse.</p></div> </div> </div> </div> </div> </div> </div> <div class="field__item"> <div class="paragraph paragraph--type--accordion-items paragraph--view-mode--default"> <div class="accordion "> <div class="accordion-group"> <div class="accordion-heading"> <button class="accordion-toggle accordion-title" data-bs-toggle="collapse" href="#accordion-paragraph--5926">Welche Vorteile haben Patienten durch die Teilnahme an klinischen Studien?</button> </div> <div id="accordion-paragraph--5926" class="accordion-body collapse " tabindex="0"> <div class="accordion-stripe-body "> <div class="clearfix text-formatted field field--name-field-accordion-body field--type-text-long field--label-hidden field__item"><p>Bei den Teilnehmerinnen und Teilnehmern wird möglicherweise eine neue Behandlung angewendet, die der breiten Öffentlichkeit noch nicht zugänglich ist. Gerade für schwerkranke Patientinnen und Patienten besteht darin häufig eine große Chance. Sie können zudem von einer medizinischen Versorgung nach dem neuesten Stand des medizinischen Wissens profitieren. Die medizinische Betreuung ist engmaschiger und intensiver als außerhalb von Studien. Nicht zuletzt leisten die Teilnehmenden einen Beitrag zum medizinischen Fortschritt und können damit anderen Betroffenen helfen.</p></div> </div> </div> </div> </div> </div> </div> <div class="field__item"> <div class="paragraph paragraph--type--accordion-items paragraph--view-mode--default"> <div class="accordion "> <div class="accordion-group"> <div class="accordion-heading"> <button class="accordion-toggle accordion-title" data-bs-toggle="collapse" href="#accordion-paragraph--5931">Welche Risiken sind mit der Teilnahme an klinischen Studien verbunden?</button> </div> <div id="accordion-paragraph--5931" class="accordion-body collapse " tabindex="0"> <div class="accordion-stripe-body "> <div class="clearfix text-formatted field field--name-field-accordion-body field--type-text-long field--label-hidden field__item"><p>Die Behandlung im Rahmen der Studie kann mit unangenehmen oder in Einzelfällen schweren Nebenwirkungen verbunden sein. Durch die engmaschigen Kontrollen wird allerdings sichergestellt, dass die Behandlung sofort abgebrochen wird, sollten derartige Nebenwirkungen auftreten. Zudem besteht die Möglichkeit, dass die Behandlung wirkungslos bleibt. Außerdem ist die Teilnahme an der Studie mit einem höheren Aufwand verbunden, zum Beispiel mit mehr Arztkontakten, möglicherweise Krankenhausaufenthalten oder komplexen Anwendungsregeln.</p></div> </div> </div> </div> </div> </div> </div> <div class="field__item"> <div class="paragraph paragraph--type--accordion-items paragraph--view-mode--default"> <div class="accordion "> <div class="accordion-group"> <div class="accordion-heading"> <button class="accordion-toggle accordion-title" data-bs-toggle="collapse" href="#accordion-paragraph--5936">Ist die Sicherheit der Teilnehmer an klinischen Studien gewährleistet?</button> </div> <div id="accordion-paragraph--5936" class="accordion-body collapse " tabindex="0"> <div class="accordion-stripe-body "> <div class="clearfix text-formatted field field--name-field-accordion-body field--type-text-long field--label-hidden field__item"><p>Die Sicherheit der Teilnehmenden steht bei der Durchführung von klinischen Studien an erster Stelle. Sie wird in Europa durch die Leitlinien zur Guten Klinischen Praxis (Good Clinical Practice, GCP) garantiert, die detaillierte Vorschriften enthalten. Demnach werden zunächst niedrige Dosierungen getestet, die langsam schrittweise erhöht werden. Die Studienärztinnen und -ärzte stellen durch ständige sorgfältige Kontrollen sicher, dass sie Nebenwirkungen sofort erfassen und bei Bedarf die Behandlung sofort abbrechen. Qualifizierte nationale Institutionen wie die Ethikkommission prüfen vor Beginn der Studie, ob Patienten möglicherweise medizinisch nicht zu rechtfertigenden Risiken ausgesetzt sind. Und auch im Verlauf der Studie kann die Ethikkommission ihre Zustimmung zum Beispiel auf Grund von auftretenden Nebenwirkungen zurückziehen.</p></div> </div> </div> </div> </div> </div> </div> <div class="field__item"> <div class="paragraph paragraph--type--accordion-items paragraph--view-mode--default"> <div class="accordion "> <div class="accordion-group"> <div class="accordion-heading"> <button class="accordion-toggle accordion-title" data-bs-toggle="collapse" href="#accordion-paragraph--5941">Wie verläuft das Zulassungsverfahren und welche Rolle spielt die Ethikkommission?</button> </div> <div id="accordion-paragraph--5941" class="accordion-body collapse " tabindex="0"> <div class="accordion-stripe-body "> <div class="clearfix text-formatted field field--name-field-accordion-body field--type-text-long field--label-hidden field__item"><p>Für jede klinische Studie muss beim Bundesamt für Sicherheit im Gesundheitswesen (BASG) ein Antrag auf Genehmigung gestellt werden. Das ist erst nach Abschluss einer umfassenden pharmakologischen und toxikologischen Prüfung möglich. Dieser Antrag umfasst die Ergebnisse präklinischer Studien, Prüfplan, Patienteninformation, Einwilligungserklärung sowie die Versicherungsbestätigung. Alle Unterlagen werden auf Unbedenklichkeit, ihre Verständlichkeit sowie unter rechtlichen Gesichtspunkten überprüft. Auch die zuständige Ethikkommission, die sich aus mehreren Medizinern, einem Juristen und einem medizinischen Laien zusammensetzt, prüft die Unterlagen sowie die Qualifikation und Eignung der Prüfärztinnen und -ärzte sowie Prüfstellen. Erst wenn Ethikkommission und BASG ihre Zustimmung erteilen, kann die klinische Studie beginnen.</p></div> </div> </div> </div> </div> </div> </div> <div class="field__item"> <div class="paragraph paragraph--type--accordion-items paragraph--view-mode--default"> <div class="accordion "> <div class="accordion-group"> <div class="accordion-heading"> <button class="accordion-toggle accordion-title" data-bs-toggle="collapse" href="#accordion-paragraph--5946">Was besagt die Einwilligungserklärung?</button> </div> <div id="accordion-paragraph--5946" class="accordion-body collapse " tabindex="0"> <div class="accordion-stripe-body "> <div class="clearfix text-formatted field field--name-field-accordion-body field--type-text-long field--label-hidden field__item"><p>Bevor eine Teilnehmerin oder ein Teilnehmer ihre bzw. seine Einwilligung erklärt, informiert ihn seine Prüfärztin oder sein Prüfarzt genau über den Ablauf der Studie sowie den Nutzen und die Risiken, die mit der Studie verbunden sind. Diese Informationen erhält der Teilnehmer auch in schriftlicher Form. Selbstverständlich hat die Patientin bzw. der Patient die Möglichkeit, all seine Fragen mit der Ärztin bzw. dem Arzt zu klären. Auch über die Weitergabe von Daten im Rahmen der Studie, die absolut vertraulich und unter Berücksichtigung des Datenschutzes erfolgt, wird der Teilnehmer informiert.</p><p>Erst nach dieser umfassenden Aufklärung und sorgfältigen Abwägung der Vor- und Nachteile, die die Studie für sie oder ihn hat, sollte die Teilnehmerin oder der Teilnehmer die schriftliche Einwilligung erteilen. Damit bestätigt sie/er, dass sie/er freiwillig an der Studie teilnimmt. Sie/er hat jederzeit das Recht, diese Einwilligung ohne Nennung von Gründen zurückzuziehen, ohne dass ihr/ihm daraus Nachteile entstehen.</p></div> </div> </div> </div> </div> </div> </div> </div> </div> </div> </div> </div> </div> </div> </div> <div class="content_bottom"> </div> </div> </div> </div> </div> </div> </section> </div> </div> </div> </div> <div class="featured-bottom"> <div class="container clearfix"> <section class="row region region-featured-bottom-first"> <div class="views-element-container block block-views block-views-blockrelated-tags-block-1" id="block-polaris-views-block-related-tags-block-1" data-block-plugin-id="views_block:related_tags-block_1"> <div class="content"> <div><div class="container view view-related-tags view-id-related_tags view-display-id-block_1 js-view-dom-id-9c227a835238565d75e0ed94595e1ebf78c7c4e5a660430c6bffe97f2e09a83c"> </div> </div> </div> </div> <div id="block-polaris-addtoanybuttons" data-block-plugin-id="addtoany_block" class="block 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