{"id":2680,"date":"2022-12-01T15:35:39","date_gmt":"2022-12-01T14:35:39","guid":{"rendered":"https:\/\/dart.datariverweb.com\/iEnter?p=2680"},"modified":"2023-04-17T15:30:03","modified_gmt":"2023-04-17T14:30:03","slug":"klinisk-forskning","status":"publish","type":"post","link":"https:\/\/dart.datariverweb.com\/iEnter?p=2680&lang=sv","title":{"rendered":"klinisk forskning"},"content":{"rendered":"\t\t<div data-elementor-type=\"wp-post\" data-elementor-id=\"2680\" class=\"elementor elementor-2680 elementor-2636\">\n\t\t\t\t\t\t\t\t\t<section class=\"elementor-section elementor-top-section elementor-element elementor-element-b179e7e elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"b179e7e\" data-element_type=\"section\">\n\t\t\t\t\t\t<div class=\"elementor-container elementor-column-gap-default\">\n\t\t\t\t\t<div class=\"elementor-column elementor-col-50 elementor-top-column elementor-element elementor-element-e99f154\" data-id=\"e99f154\" data-element_type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t\t\t<div class=\"elementor-element elementor-element-2e8c2f1 elementor-view-default elementor-widget elementor-widget-icon\" data-id=\"2e8c2f1\" data-element_type=\"widget\" data-widget_type=\"icon.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<div class=\"elementor-icon-wrapper\">\n\t\t\t<a class=\"elementor-icon\" href=\"https:\/\/dart.datariverweb.com\/iEnter?page_id=2307&#038;lang=sv\">\n\t\t\t<i aria-hidden=\"true\" class=\"fas fa-arrow-left\"><\/i>\t\t\t<\/a>\n\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t<div class=\"elementor-column elementor-col-50 elementor-top-column elementor-element elementor-element-39925bd\" data-id=\"39925bd\" data-element_type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t\t\t<div class=\"elementor-element elementor-element-eebf7f6 elementor-widget elementor-widget-heading\" data-id=\"eebf7f6\" data-element_type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t<style>\/*! elementor - v3.8.0 - 30-10-2022 *\/\n.elementor-heading-title{padding:0;margin:0;line-height:1}.elementor-widget-heading .elementor-heading-title[class*=elementor-size-]>a{color:inherit;font-size:inherit;line-height:inherit}.elementor-widget-heading .elementor-heading-title.elementor-size-small{font-size:15px}.elementor-widget-heading .elementor-heading-title.elementor-size-medium{font-size:19px}.elementor-widget-heading .elementor-heading-title.elementor-size-large{font-size:29px}.elementor-widget-heading .elementor-heading-title.elementor-size-xl{font-size:39px}.elementor-widget-heading .elementor-heading-title.elementor-size-xxl{font-size:59px}<\/style><h3 class=\"elementor-heading-title elementor-size-default\"><a href=\"https:\/\/dart.datariverweb.com\/iEnter?page_id=2307&#038;lang=sv\">Tillbaka till f\u00f6r mer information\n<\/a><\/h3>\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t<section class=\"elementor-section elementor-top-section elementor-element elementor-element-660f7547 elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"660f7547\" data-element_type=\"section\">\n\t\t\t\t\t\t<div class=\"elementor-container elementor-column-gap-default\">\n\t\t\t\t\t<div class=\"elementor-column elementor-col-100 elementor-top-column elementor-element elementor-element-193cc8a4\" data-id=\"193cc8a4\" data-element_type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t\t\t<div class=\"elementor-element elementor-element-63599ad elementor-aspect-ratio-169 elementor-widget elementor-widget-video\" data-id=\"63599ad\" data-element_type=\"widget\" data-settings=\"{&quot;video_type&quot;:&quot;vimeo&quot;,&quot;aspect_ratio&quot;:&quot;169&quot;}\" data-widget_type=\"video.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t<style>\/*! elementor - v3.8.0 - 30-10-2022 *\/\n.elementor-widget-video .elementor-widget-container{overflow:hidden;-webkit-transform:translateZ(0);transform:translateZ(0)}.elementor-widget-video .elementor-open-inline .elementor-custom-embed-image-overlay{position:absolute;top:0;left:0;width:100%;height:100%;background-size:cover;background-position:50%}.elementor-widget-video .elementor-custom-embed-image-overlay{cursor:pointer;text-align:center}.elementor-widget-video .elementor-custom-embed-image-overlay:hover .elementor-custom-embed-play i{opacity:1}.elementor-widget-video .elementor-custom-embed-image-overlay img{display:block;width:100%}.elementor-widget-video .e-hosted-video .elementor-video{-o-object-fit:cover;object-fit:cover}.e-con-inner>.elementor-widget-video,.e-con>.elementor-widget-video{width:var(--container-widget-width,100%)}<\/style>\t\t<div class=\"elementor-wrapper elementor-fit-aspect-ratio elementor-open-inline\">\n\t\t\t<iframe class=\"elementor-video-iframe\" allowfullscreen title=\"vimeo Video Player\" src=\"https:\/\/player.vimeo.com\/video\/235215203?color&amp;autopause=0&amp;loop=0&amp;muted=0&amp;title=1&amp;portrait=1&amp;byline=1#t=\"><\/iframe>\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-06cbe84 elementor-widget elementor-widget-heading\" data-id=\"06cbe84\" data-element_type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t<h3 class=\"elementor-heading-title elementor-size-default\">Vad \u00e4r klinisk forskning?\n<\/h3>\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-4ad45b9 elementor-widget-divider--view-line elementor-widget elementor-widget-divider\" data-id=\"4ad45b9\" data-element_type=\"widget\" data-widget_type=\"divider.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t<style>\/*! elementor - v3.8.0 - 30-10-2022 *\/\n.elementor-widget-divider{--divider-border-style:none;--divider-border-width:1px;--divider-color:#2c2c2c;--divider-icon-size:20px;--divider-element-spacing:10px;--divider-pattern-height:24px;--divider-pattern-size:20px;--divider-pattern-url:none;--divider-pattern-repeat:repeat-x}.elementor-widget-divider .elementor-divider{display:-webkit-box;display:-ms-flexbox;display:flex}.elementor-widget-divider .elementor-divider__text{font-size:15px;line-height:1;max-width:95%}.elementor-widget-divider .elementor-divider__element{margin:0 var(--divider-element-spacing);-ms-flex-negative:0;flex-shrink:0}.elementor-widget-divider .elementor-icon{font-size:var(--divider-icon-size)}.elementor-widget-divider .elementor-divider-separator{display:-webkit-box;display:-ms-flexbox;display:flex;margin:0;direction:ltr}.elementor-widget-divider--view-line_icon .elementor-divider-separator,.elementor-widget-divider--view-line_text .elementor-divider-separator{-webkit-box-align:center;-ms-flex-align:center;align-items:center}.elementor-widget-divider--view-line_icon .elementor-divider-separator:after,.elementor-widget-divider--view-line_icon .elementor-divider-separator:before,.elementor-widget-divider--view-line_text .elementor-divider-separator:after,.elementor-widget-divider--view-line_text .elementor-divider-separator:before{display:block;content:\"\";border-bottom:0;-webkit-box-flex:1;-ms-flex-positive:1;flex-grow:1;border-top:var(--divider-border-width) var(--divider-border-style) var(--divider-color)}.elementor-widget-divider--element-align-left .elementor-divider .elementor-divider-separator>.elementor-divider__svg:first-of-type{-webkit-box-flex:0;-ms-flex-positive:0;flex-grow:0;-ms-flex-negative:100;flex-shrink:100}.elementor-widget-divider--element-align-left .elementor-divider-separator:before{content:none}.elementor-widget-divider--element-align-left .elementor-divider__element{margin-left:0}.elementor-widget-divider--element-align-right .elementor-divider .elementor-divider-separator>.elementor-divider__svg:last-of-type{-webkit-box-flex:0;-ms-flex-positive:0;flex-grow:0;-ms-flex-negative:100;flex-shrink:100}.elementor-widget-divider--element-align-right .elementor-divider-separator:after{content:none}.elementor-widget-divider--element-align-right .elementor-divider__element{margin-right:0}.elementor-widget-divider:not(.elementor-widget-divider--view-line_text):not(.elementor-widget-divider--view-line_icon) .elementor-divider-separator{border-top:var(--divider-border-width) var(--divider-border-style) var(--divider-color)}.elementor-widget-divider--separator-type-pattern{--divider-border-style:none}.elementor-widget-divider--separator-type-pattern.elementor-widget-divider--view-line .elementor-divider-separator,.elementor-widget-divider--separator-type-pattern:not(.elementor-widget-divider--view-line) .elementor-divider-separator:after,.elementor-widget-divider--separator-type-pattern:not(.elementor-widget-divider--view-line) .elementor-divider-separator:before,.elementor-widget-divider--separator-type-pattern:not([class*=elementor-widget-divider--view]) .elementor-divider-separator{width:100%;min-height:var(--divider-pattern-height);-webkit-mask-size:var(--divider-pattern-size) 100%;mask-size:var(--divider-pattern-size) 100%;-webkit-mask-repeat:var(--divider-pattern-repeat);mask-repeat:var(--divider-pattern-repeat);background-color:var(--divider-color);-webkit-mask-image:var(--divider-pattern-url);mask-image:var(--divider-pattern-url)}.elementor-widget-divider--no-spacing{--divider-pattern-size:auto}.elementor-widget-divider--bg-round{--divider-pattern-repeat:round}.rtl .elementor-widget-divider .elementor-divider__text{direction:rtl}.e-con-inner>.elementor-widget-divider,.e-con>.elementor-widget-divider{width:var(--container-widget-width,100%)}<\/style>\t\t<div class=\"elementor-divider\">\n\t\t\t<span class=\"elementor-divider-separator\">\n\t\t\t\t\t\t<\/span>\n\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-28ba5aac elementor-widget elementor-widget-text-editor\" data-id=\"28ba5aac\" data-element_type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t<style>\/*! elementor - v3.8.0 - 30-10-2022 *\/\n.elementor-widget-text-editor.elementor-drop-cap-view-stacked .elementor-drop-cap{background-color:#818a91;color:#fff}.elementor-widget-text-editor.elementor-drop-cap-view-framed .elementor-drop-cap{color:#818a91;border:3px solid;background-color:transparent}.elementor-widget-text-editor:not(.elementor-drop-cap-view-default) .elementor-drop-cap{margin-top:8px}.elementor-widget-text-editor:not(.elementor-drop-cap-view-default) .elementor-drop-cap-letter{width:1em;height:1em}.elementor-widget-text-editor .elementor-drop-cap{float:left;text-align:center;line-height:1;font-size:50px}.elementor-widget-text-editor .elementor-drop-cap-letter{display:inline-block}<\/style>\t\t\t\t<p><span style=\"font-weight: 400;\">Medicinsk praxis bygger p\u00e5 f\u00f6rebyggande, diagnostiska och terapeutiska interventioner vars effektivitet (f\u00f6rdelar) och s\u00e4kerhet (avsaknad av o\u00f6nskade effekter) m\u00e5ste bevisas genom rigor\u00f6s medicinsk forskning. <\/span><\/p>\n<p><span style=\"font-weight: 400;\">Preklinisk forskning \u00e4r medicinsk forskning som utf\u00f6rs i ett laboratorium utan direkt medverkan av patienter och som syftar till att samla in prelimin\u00e4ra uppgifter om s\u00e4kerhet och effekt, medan klinisk forskning involverar m\u00e4nniskor i s\u00e5 kallade &#8220;kliniska studier&#8221; och syftar till att utv\u00e4rdera effekt och s\u00e4kerhet av terapeutiska interventioner i den kliniska milj\u00f6n. <\/span><\/p>\n<p> <\/p>\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-837ed2d elementor-widget elementor-widget-heading\" data-id=\"837ed2d\" data-element_type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t<h3 class=\"elementor-heading-title elementor-size-default\">Kliniska studier \n\n<\/h3>\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-3801c40 elementor-widget-divider--view-line elementor-widget elementor-widget-divider\" data-id=\"3801c40\" data-element_type=\"widget\" data-widget_type=\"divider.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<div class=\"elementor-divider\">\n\t\t\t<span class=\"elementor-divider-separator\">\n\t\t\t\t\t\t<\/span>\n\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-b28f5c6 elementor-widget elementor-widget-text-editor\" data-id=\"b28f5c6\" data-element_type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<p><span style=\"font-weight: 400;\">Vissa kliniska studier \u00e4r observationsstudier, vilket inneb\u00e4r att forskarna observerar den &#8220;naturliga utvecklingen&#8221; hos patienter som behandlas enligt rutinm\u00e4ssig klinisk praxis (v\u00e5rdstandard) genom att samla in data om behandlingsresultat och annan patient- och sjukdomsinformation Dessa studier kallas ocks\u00e5 icke-interventionella eller icke-experimentella. <\/span><\/p>\n<p><span style=\"font-weight: 400;\">Andra kliniska studier \u00e4r d\u00e4remot experimentella (eller interventionella) och kallas<\/span> <b>kliniska pr\u00f6vningar<\/b><span style=\"font-weight: 400;\">.<\/span> <\/p>\n<p><span style=\"font-weight: 400;\">N\u00e4r det r\u00e5der os\u00e4kerhet om vilken behandling som \u00e4r b\u00e4st f\u00f6r ett visst h\u00e4lsotillst\u00e5nd beh\u00f6vs kliniska pr\u00f6vningar. Detta tillst\u00e5nd kallas &#8220;klinisk j\u00e4mvikt\u201d. Kliniska pr\u00f6vningar \u00e4r den mest tillf\u00f6rlitliga metoden f\u00f6r att bed\u00f6ma effektiviteten och s\u00e4kerheten hos interventioner, s\u00e5 att man kan fastst\u00e4lla vilken intervention som ska anv\u00e4ndas i klinisk praxis. Det finns olika typer av kliniska pr\u00f6vningar, beroende p\u00e5 forskningsfr\u00e5gan och till\u00e4mpad metodik.<\/span><\/p>\n<p><span style=\"font-weight: 400;\">I vissa kliniska pr\u00f6vningar testas den nya interventionen utan j\u00e4mf\u00f6relser. Detta beror p\u00e5 pr\u00f6vningens syfte och fas (se &#8220;Faser i kliniska pr\u00f6vningar&#8221; och figur 1). I detta fall definieras studien som <\/span><b>okontrollerad eller enarmad studie.<\/b><\/p>\n<p><span style=\"font-weight: 400;\">F\u00f6r att undvika otillb\u00f6rlig p\u00e5verkan fr\u00e5n forskaren vid bed\u00f6mningen av interventionens effekt och\/eller rapporteringen av patienternas symtom och resultat kan tilldelningen till interventions- eller kontrollarmen vara blindad eller maskerad. Om varken l\u00e4karen eller patienten k\u00e4nner till vilken behandlingsarm som tilldelats kallas den kliniska pr\u00f6vningen &#8220;dubbelblind&#8221; eller &#8220;dubbelmaskerad&#8221; (se &#8220;blindning eller maskering&#8221;). I \u00f6ppna pr\u00f6vningar \u00e4r d\u00e4remot alla (forskare och deltagare) medvetna om vilken behandlingsarm som har tilldelats. (Se blinda och dubbelblinda studier).<\/span><\/p>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-8f5e587 elementor-widget elementor-widget-heading\" data-id=\"8f5e587\" data-element_type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t<h3 class=\"elementor-heading-title elementor-size-default\">Typer av kliniska pr\u00f6vningar\n\n\n<\/h3>\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-0c26ff5 elementor-widget-divider--view-line elementor-widget elementor-widget-divider\" data-id=\"0c26ff5\" data-element_type=\"widget\" data-widget_type=\"divider.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<div class=\"elementor-divider\">\n\t\t\t<span class=\"elementor-divider-separator\">\n\t\t\t\t\t\t<\/span>\n\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-98c199b elementor-widget elementor-widget-text-editor\" data-id=\"98c199b\" data-element_type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<p><span style=\"font-weight: 400;\">Kliniska pr\u00f6vningar g\u00f6r det m\u00f6jligt att j\u00e4mf\u00f6ra en ny behandling (experimentell) med en annan som redan anv\u00e4nds i klinisk praxis (kontroll) f\u00f6r att behandla det h\u00e4lsotillst\u00e5nd som studeras. Dessa kallas <\/span><b>kontrollerade kliniska pr\u00f6vningar.<\/b><span style=\"font-weight: 400;\">. I vissa fall \u00e4r den experimentella behandlingen inte ny och har redan godk\u00e4nts f\u00f6r andra h\u00e4lsotillst\u00e5nd. I andra fall, d\u00e4r ingen standard \u00e4r tillg\u00e4nglig, kan kontrollbehandlingen vara placebo, dvs. anv\u00e4ndning av ett inaktivt \u00e4mne. I kontrollerade kliniska pr\u00f6vningar f\u00f6rdelas patienterna till den grupp som f\u00e5r den nya behandlingen (f\u00f6rs\u00f6ksgrupp) eller till den grupp som f\u00e5r kontrollbehandlingen (kontrollgrupp). Forskare anv\u00e4nder ofta termen &#8220;arm&#8221; f\u00f6r att definiera dessa patientgrupper. N\u00e4r f\u00f6rdelningen sker slumpm\u00e4ssigt (slumpm\u00e4ssigt, som att kasta ett mynt) kallas studierna f\u00f6r<\/span><b> randomiserade kontrollerade pr\u00f6vningar<\/b><span style=\"font-weight: 400;\"> (se &#8220;Randomisering&#8221;). Syftet med slumpm\u00e4ssig f\u00f6rdelning \u00e4r att bilda grupper som liknar varandra, s\u00e5 att skillnaderna mellan de tv\u00e5 grupperna n\u00e4r det g\u00e4ller slutresultaten beror p\u00e5 de olika interventionerna som de f\u00e5tt och inte p\u00e5 redan befintliga skillnader. <\/span><\/p>\n<p><span style=\"font-weight: 400;\">I vissa kliniska pr\u00f6vningar testas den nya interventionen utan j\u00e4mf\u00f6relser. Detta beror p\u00e5 pr\u00f6vningens syfte och fas (se &#8220;Faser i kliniska pr\u00f6vningar&#8221; och figur 1). I detta fall definieras studien som <\/span><b>okontrollerad eller enarmad studie.<\/b><\/p>\n<p><span style=\"font-weight: 400;\">F\u00f6r att undvika otillb\u00f6rlig p\u00e5verkan fr\u00e5n forskaren vid bed\u00f6mningen av interventionens effekt och\/eller rapporteringen av patienternas symtom och resultat kan tilldelningen till interventions- eller kontrollarmen vara blindad eller maskerad. Om varken l\u00e4karen eller patienten k\u00e4nner till vilken behandlingsarm som tilldelats kallas den kliniska pr\u00f6vningen &#8220;dubbelblind&#8221; eller &#8220;dubbelmaskerad&#8221; (se &#8220;blindning eller maskering&#8221;). I \u00f6ppna pr\u00f6vningar \u00e4r d\u00e4remot alla (forskare och deltagare) medvetna om vilken behandlingsarm som har tilldelats. (Se blinda och dubbelblinda studier).<\/span><\/p>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-086878d elementor-widget elementor-widget-heading\" data-id=\"086878d\" data-element_type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t<h3 class=\"elementor-heading-title elementor-size-default\">Studieprotokoll. Etikkommitt\u00e9 och informerat samtycke \n\n<\/h3>\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-be876e3 elementor-widget-divider--view-line elementor-widget elementor-widget-divider\" data-id=\"be876e3\" data-element_type=\"widget\" data-widget_type=\"divider.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<div class=\"elementor-divider\">\n\t\t\t<span class=\"elementor-divider-separator\">\n\t\t\t\t\t\t<\/span>\n\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-b3ae0b7 elementor-widget elementor-widget-text-editor\" data-id=\"b3ae0b7\" data-element_type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<p><span style=\"font-weight: 400;\">N\u00e4r forskare genomf\u00f6r en klinisk studie m\u00e5ste de alltid f\u00f6lja en skriftlig plan, \u00e4ven kallad &#8220;studieprotokoll&#8221;. Protokollet definieras innan studien p\u00e5b\u00f6rjas och inneh\u00e5ller en detaljerad beskrivning av studiens m\u00e5l, utformning, metodik, organisation och genomf\u00f6rande<\/span><i><span style=\"font-weight: 400;\">(l\u00e4nk till ordlistan<\/span><\/i> <span style=\"font-weight: 400;\">\u201cProtokollet\u201d)<\/span><\/p>\n<p><span style=\"font-weight: 400;\">Alla kliniska studier m\u00e5ste godk\u00e4nnas av en Etikkommitt\u00e9<\/span> <i><span style=\"font-weight: 400;\">(l\u00e4nk till ordlistan<\/span><\/i> <span style=\"font-weight: 400;\">Etikkommitt\u00e9) innan patienter b\u00f6rjar rekryteras. Etikkommitt\u00e9n \u00e4r en tv\u00e4rvetenskaplig expertgrupp som utv\u00e4rderar forskningsprotokollet ur vetenskaplig och etisk synvinkel. <\/span><\/p>\n<p><span style=\"font-weight: 400;\">F\u00f6r att patienten ska kunna besluta om att delta i en klinisk studie ska l\u00e4karen ge patienten ett dokument med all information om studien. Om patienten frivilligt beslutar att delta m\u00e5ste formul\u00e4ret om informerat samtycke skrivas under och dateras. se <a href=\"https:\/\/dart.datariverweb.com\/iEnter?p=2314&#038;lang=sv\">\u201cInformerat samtycke\u201d<\/a><\/span><\/p>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-375db25 elementor-widget elementor-widget-heading\" data-id=\"375db25\" data-element_type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t<h3 class=\"elementor-heading-title elementor-size-default\">Faser i kliniska pr\u00f6vningar\n\n<\/h3>\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-371ae87 elementor-widget-divider--view-line elementor-widget elementor-widget-divider\" data-id=\"371ae87\" data-element_type=\"widget\" data-widget_type=\"divider.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<div class=\"elementor-divider\">\n\t\t\t<span class=\"elementor-divider-separator\">\n\t\t\t\t\t\t<\/span>\n\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-2f1c5b8 elementor-widget elementor-widget-text-editor\" data-id=\"2f1c5b8\" data-element_type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<p><span style=\"font-weight: 400;\">Ett nytt l\u00e4kemedel genomg\u00e5r flera testfaser under sin kliniska utvecklingsprocess. Om en fas visar att l\u00e4kemedlet har en acceptabel toxicitetsniv\u00e5 i f\u00f6rh\u00e5llande till den f\u00f6rv\u00e4ntade nyttan kan den efterf\u00f6ljande f\u00f6rs\u00f6ksfasen inledas.<\/span><\/p>\n<p><span style=\"font-weight: 400;\">Varje fas har olika inriktning:<\/span><\/p>\n<p><span style=\"font-weight: 400;\">Fas 1-studier testar om en ny behandling \u00e4r ofarlig och svarar p\u00e5 fr\u00e5gan: \u201d\u00c4r den s\u00e4ker?\u201d Dessa studier utf\u00f6rs vanligtvis p\u00e5 ett begr\u00e4nsat antal friska frivilliga individer. Vissa fas 1-studier (t.ex. inom onkologi) \u00e4r dock inriktade p\u00e5 patienter snarare \u00e4n friska m\u00e4nniskor. Det fr\u00e4msta syftet \u00e4r att bed\u00f6ma eventuella biverkningar av behandlingen samt var och hur de upptr\u00e4der.<\/span><\/p>\n<p><span style=\"font-weight: 400;\">Fas 2-studier testar behandlingens terapeutiska aktivitet (dvs. dess f\u00f6rm\u00e5ga att ge \u00f6nskade effekter p\u00e5 m\u00e4nniskokroppen) och svarar p\u00e5 fr\u00e5gan: &#8220;Vad har den f\u00f6r effekt?&#8221; De utf\u00f6rs p\u00e5 en st\u00f6rre grupp deltagare, friska personer eller patienter.<\/span><\/p>\n<p><span style=\"font-weight: 400;\">Fas 3-studier testar den nya behandlingens effektivitet och svarar p\u00e5 fr\u00e5gan: &#8220;Fungerar den?&#8221; I den h\u00e4r fasen j\u00e4mf\u00f6rs den nya behandlingen med standardbehandlingen eller med placebo f\u00f6r att testa dess effektivitet och biverkningar, vanligtvis genom en randomiserad kontrollerad studie i utvalda patientgrupper. <\/span><\/p>\n<p><span style=\"font-weight: 400;\">Fas 4-studier \u00e4ger rum n\u00e4r l\u00e4kemedlet har godk\u00e4nts av tillsynsmyndigheterna och \u00e4r tillg\u00e4ngligt p\u00e5 marknaden. Syftet med denna fas \u00e4r att hitta mer information om l\u00e5ngsiktiga f\u00f6rdelar och biverkningar vid utbredd anv\u00e4ndning i klinisk praxis. De svarar p\u00e5 fr\u00e5gan &#8220;Fungerar det i klinisk praxis?&#8221;<\/span><\/p>\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-a3cac61 elementor-widget elementor-widget-heading\" data-id=\"a3cac61\" data-element_type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t<h3 class=\"elementor-heading-title elementor-size-default\">Korgstudier\n\n<\/h3>\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-636f8d3 elementor-widget-divider--view-line elementor-widget elementor-widget-divider\" data-id=\"636f8d3\" data-element_type=\"widget\" data-widget_type=\"divider.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<div class=\"elementor-divider\">\n\t\t\t<span class=\"elementor-divider-separator\">\n\t\t\t\t\t\t<\/span>\n\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-87a9daa elementor-widget elementor-widget-text-editor\" data-id=\"87a9daa\" data-element_type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<p><span style=\"font-weight: 400;\">Korgstudier \u00e4r en ny typ av kliniska pr\u00f6vningar som fokuserar p\u00e5 behandling av cancerpatienter med en viss genetisk mutation eller molekyl\u00e4r profil i syfte att utv\u00e4rdera en riktad behandling. Korgstudier anv\u00e4nder ofta en metod som kallas \u201cenarmad\u201d, vilket inneb\u00e4r att man utv\u00e4rderar effekten av ett l\u00e4kemedel utan att anv\u00e4nda en j\u00e4mf\u00f6relsegrupp (<\/span><i><span style=\"font-weight: 400;\">(l\u00e4nk till avsnittet Bob-studier<\/span><\/i> <span style=\"font-weight: 400;\">).<\/span> <span style=\"font-weight: 400;\">Om du vill veta mer om kliniska studier kan du titta p\u00e5 den animerade kortfilmen som utformats och producerats inom det EU-finansierade ECRAN-projektet:<\/span> <b>https:\/\/vimeo.com\/69337236.<\/b><\/p>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-841578b elementor-widget elementor-widget-heading\" data-id=\"841578b\" data-element_type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t<h3 class=\"elementor-heading-title elementor-size-default\">Kliniska pr\u00f6vningar: viktiga saker du b\u00f6r veta\n\n<\/h3>\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-e799a7b elementor-widget-divider--view-line elementor-widget elementor-widget-divider\" data-id=\"e799a7b\" data-element_type=\"widget\" data-widget_type=\"divider.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<div class=\"elementor-divider\">\n\t\t\t<span class=\"elementor-divider-separator\">\n\t\t\t\t\t\t<\/span>\n\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-9d06435 elementor-widget elementor-widget-text-editor\" data-id=\"9d06435\" data-element_type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<ul>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">\u201cNya behandlingar&#8221; \u00e4r inte n\u00f6dv\u00e4ndigtvis b\u00e4ttre \u00e4n standardbehandlingar n\u00e4r det g\u00e4ller effektivitet och s\u00e4kerhet.<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Patienter b\u00f6r v\u00e4ljas till en klinisk pr\u00f6vning om de sannolikt kommer att ha st\u00f6rst nytta av den nya behandlingen.<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Av etiska sk\u00e4l \u00e4r det inte till\u00e5tet med placebokontrollgrupper om det redan finns en standardbehandling som patienterna kan anv\u00e4nda sig av. I s\u00e5dana fall ska den b\u00e4sta tillg\u00e4ngliga standardbehandlingen anv\u00e4ndas som kontroll.<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Kliniska pr\u00f6vningar styrs av internationella riktlinjer och lagkrav f\u00f6r att skydda deltagarna och garantera deras s\u00e4kerhet. <\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Innan kliniska pr\u00f6vningar genomf\u00f6rs med patienter m\u00e5ste flera studier (vanligtvis indelade i &#8220;faser&#8221;) ha genomf\u00f6rts i laboratorier &#8211; inom laboratorieforskning och preklinisk forskning. Om dessa studier ger tillfredsst\u00e4llande resultat testas l\u00e4kemedlet i kliniska pr\u00f6vningar. Det slutgiltiga m\u00e5let med en klinisk pr\u00f6vning \u00e4r att ta resultaten fr\u00e5n laboratoriet till kliniken och att omvandla den forskning som bedrivs i laboratorier till konkreta s\u00e4tt att hj\u00e4lpa patienter. <\/span><\/li>\n<\/ul>\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-c91b6e9 elementor-widget elementor-widget-heading\" data-id=\"c91b6e9\" data-element_type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t<h3 class=\"elementor-heading-title elementor-size-default\">Hur kan jag hitta r\u00e4tt klinisk pr\u00f6vning f\u00f6r mig?\n<\/h3>\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-a148e4e elementor-widget-divider--view-line elementor-widget elementor-widget-divider\" data-id=\"a148e4e\" data-element_type=\"widget\" data-widget_type=\"divider.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<div class=\"elementor-divider\">\n\t\t\t<span class=\"elementor-divider-separator\">\n\t\t\t\t\t\t<\/span>\n\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-b2dfebb elementor-widget elementor-widget-text-editor\" data-id=\"b2dfebb\" data-element_type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<p><span style=\"font-weight: 400;\">Om du funderar p\u00e5 att delta i en klinisk pr\u00f6vning \u00e4r det f\u00f6rsta och enklaste steget att fr\u00e5ga din l\u00e4kare, eftersom din l\u00e4kare k\u00e4nner till ditt sjukdomstillst\u00e5nd, vet allt om dina provsvar och kan h\u00e4nvisa dig till de l\u00e4mpligaste pr\u00f6vningarna p\u00e5 lokala sjukhus, forskningscentra eller universitet.<\/span><\/p>\n<p><span style=\"font-weight: 400;\">Att tr\u00e4ffa andra personer som har f\u00e5tt samma diagnos \u00e4r ocks\u00e5 ett bra s\u00e4tt f\u00f6r att f\u00e5 information. Patientf\u00f6reningar \u00e4r vanligtvis mycket hj\u00e4lpsamma och du kan f\u00e5 information direkt p\u00e5 deras webbplatser. <\/span><\/p>\n<p><span style=\"font-weight: 400;\">Du kan ocks\u00e5 g\u00f6ra en s\u00f6kning i ett register \u00f6ver kliniska pr\u00f6vningar som inneh\u00e5ller kliniska studier som genomf\u00f6rs runt om i v\u00e4rlden<\/span> <a href=\"https:\/\/www.clinicaltrials.gov\/\"><span style=\"font-weight: 400;\">(https:\/\/www.clinicaltrials.gov\/<\/span><\/a> <span style=\"font-weight: 400;\">) eller kliniska pr\u00f6vningar som genomf\u00f6rs p\u00e5 europeisk niv\u00e5<\/span> <a href=\"https:\/\/www.clinicaltrialsregister.eu\/ctr-search\/search\"><span style=\"font-weight: 400;\">(https:\/\/www.clinicaltrialsregister.eu\/ctr-search\/search.).<\/span><\/a><span style=\"font-weight: 400;\">.). F\u00f6r varje studie kan du l\u00e4sa en sammanfattning av studieprotokollet, ta reda p\u00e5 var studierna \u00e4ger rum och f\u00e5 specifik kontaktinformation. Om du hittar en klinisk pr\u00f6vning som du kan vara intresserad av b\u00f6r du prata om den med din l\u00e4kare.<\/span><\/p>\n<p><span style=\"font-weight: 400;\">G\u00e5 alltid igenom hela processen f\u00f6r informerat samtycke innan du fattar ditt slutgiltiga beslut. \u00c4ven om det kan vara en tidskr\u00e4vande process \u00e4r det viktigt att se till att du f\u00f6rst\u00e5r vad du skriver under p\u00e5.<\/span><\/p>\n<p><span style=\"font-weight: 400;\">K\u00e4lla: ECRAN &#8211; European Communication on Research Awareness Needs \u2013 ett projekt som finansieras av Europeiska unionens sjunde ramprogram.<\/span><\/p>\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-d643377 elementor-widget elementor-widget-image\" data-id=\"d643377\" data-element_type=\"widget\" data-widget_type=\"image.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t<style>\/*! elementor - v3.8.0 - 30-10-2022 *\/\n.elementor-widget-image{text-align:center}.elementor-widget-image a{display:inline-block}.elementor-widget-image a img[src$=\".svg\"]{width:48px}.elementor-widget-image img{vertical-align:middle;display:inline-block}<\/style>\t\t\t\t\t\t\t\t\t\t\t\t<img loading=\"lazy\" decoding=\"async\" width=\"768\" height=\"879\" src=\"https:\/\/dart.datariverweb.com\/iEnter\/wp-content\/uploads\/2022\/12\/INT-Infografica-INGLESE-768x879.jpg\" class=\"attachment-medium_large size-medium_large\" alt=\"\" srcset=\"https:\/\/dart.datariverweb.com\/iEnter\/wp-content\/uploads\/2022\/12\/INT-Infografica-INGLESE-768x879.jpg 768w, https:\/\/dart.datariverweb.com\/iEnter\/wp-content\/uploads\/2022\/12\/INT-Infografica-INGLESE-262x300.jpg 262w, https:\/\/dart.datariverweb.com\/iEnter\/wp-content\/uploads\/2022\/12\/INT-Infografica-INGLESE-895x1024.jpg 895w, https:\/\/dart.datariverweb.com\/iEnter\/wp-content\/uploads\/2022\/12\/INT-Infografica-INGLESE-1342x1536.jpg 1342w, https:\/\/dart.datariverweb.com\/iEnter\/wp-content\/uploads\/2022\/12\/INT-Infografica-INGLESE.jpg 1600w\" sizes=\"auto, (max-width: 768px) 100vw, 768px\" \/>\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t\t\t\t<\/div>\n\t\t","protected":false},"excerpt":{"rendered":"<p>Medicinsk praxis bygger p\u00e5 f\u00f6rebyggande, diagnostiska och terapeutiska interventioner vars effektivitet (f\u00f6rdelar) och s\u00e4kerhet (avsaknad av o\u00f6nskade effekter) m\u00e5ste bevisas genom rigor\u00f6s medicinsk forskning.<br \/>\nPreklinisk forskning \u00e4r medicinsk forskning som utf\u00f6rs i ett laboratorium utan direkt medverkan av patienter och som syftar till att samla in prelimin\u00e4ra uppgifter om s\u00e4kerhet och effekt, medan klinisk forskning involverar m\u00e4nniskor i s\u00e5 kallade &#8220;kliniska studier&#8221; och syftar till att utv\u00e4rdera effekt och s\u00e4kerhet av terapeutiska interventioner i den kliniska milj\u00f6n. <\/p>\n","protected":false},"author":5,"featured_media":2806,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"om_disable_all_campaigns":false,"_mi_skip_tracking":false,"_monsterinsights_sitenote_active":false,"_monsterinsights_sitenote_note":"","_monsterinsights_sitenote_category":0,"_uf_show_specific_survey":0,"_uf_disable_surveys":false,"footnotes":""},"categories":[80,75],"tags":[],"class_list":["post-2680","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-klinisk","category-trials-sv"],"blocksy_meta":{"styles_descriptor":{"styles":{"desktop":"","tablet":"","mobile":""},"google_fonts":[],"version":5}},"aioseo_notices":[],"_links":{"self":[{"href":"https:\/\/dart.datariverweb.com\/iEnter\/index.php?rest_route=\/wp\/v2\/posts\/2680","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/dart.datariverweb.com\/iEnter\/index.php?rest_route=\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/dart.datariverweb.com\/iEnter\/index.php?rest_route=\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/dart.datariverweb.com\/iEnter\/index.php?rest_route=\/wp\/v2\/users\/5"}],"replies":[{"embeddable":true,"href":"https:\/\/dart.datariverweb.com\/iEnter\/index.php?rest_route=%2Fwp%2Fv2%2Fcomments&post=2680"}],"version-history":[{"count":24,"href":"https:\/\/dart.datariverweb.com\/iEnter\/index.php?rest_route=\/wp\/v2\/posts\/2680\/revisions"}],"predecessor-version":[{"id":3604,"href":"https:\/\/dart.datariverweb.com\/iEnter\/index.php?rest_route=\/wp\/v2\/posts\/2680\/revisions\/3604"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/dart.datariverweb.com\/iEnter\/index.php?rest_route=\/wp\/v2\/media\/2806"}],"wp:attachment":[{"href":"https:\/\/dart.datariverweb.com\/iEnter\/index.php?rest_route=%2Fwp%2Fv2%2Fmedia&parent=2680"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/dart.datariverweb.com\/iEnter\/index.php?rest_route=%2Fwp%2Fv2%2Fcategories&post=2680"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/dart.datariverweb.com\/iEnter\/index.php?rest_route=%2Fwp%2Fv2%2Ftags&post=2680"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}