{"id":2636,"date":"2021-08-17T15:35:39","date_gmt":"2021-08-17T14:35:39","guid":{"rendered":"https:\/\/dart.datariverweb.com\/iEnter?p=2636"},"modified":"2023-04-17T15:30:03","modified_gmt":"2023-04-17T14:30:03","slug":"clinical-trial","status":"publish","type":"post","link":"https:\/\/dart.datariverweb.com\/iEnter?p=2636","title":{"rendered":"Clinical Trials"},"content":{"rendered":"\t\t<div data-elementor-type=\"wp-post\" data-elementor-id=\"2636\" class=\"elementor 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=283\">\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=283\">Back to know more\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\/787626781?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\">What is clinical research?\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;\">Medical practice is based on preventive, diagnostic and therapeutic interventions, whose efficacy (benefits) and safety (absence of unwanted effects) must be proven through rigorous medical research.\u00a0<\/span><\/p>\n<p><span style=\"font-weight: 400;\">While pre-clinical research is medical research carried out in a laboratory, without direct patient involvement and is aimed at collecting preliminary safety and efficacy data, clinical research involves people in so called \u201cclinical studies\u201d and is aimed at evaluating efficacy and safety of therapeutic interventions in the clinical setting.\u00a0<\/span><\/p>\n<p>\u00a0<\/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\">Clinical studies \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;\">Some clinical studies are observational, meaning that researchers observe the \u201cnatural history\u201d of patients treated according to routine clinical practice (standard of care), by collecting data on therapy outcomes and other patients\u2019 and disease information. These studies are also called non-interventional or non-experimental.\u00a0<\/span><\/p><p><span style=\"font-weight: 400;\">Instead, other clinical studies are experimental (or interventional) and are called <\/span><b>clinical trials<\/b><span style=\"font-weight: 400;\">.\u00a0<\/span><\/p><p><span style=\"font-weight: 400;\">When there is a state of genuine uncertainty regarding the best treatment for a specific health condition, clinical trials are needed. This condition is called \u201cequipoise\u201d. Clinical trials are the most reliable method for assessing the efficacy and safety of interventions, in order to establish which one to use in clinical practice. There are different types of clinical trials, according to the research question and to the applied methodology.<\/span><\/p><p><span style=\"font-weight: 400;\">Some clinical trials test the new intervention without making comparisons. This depends on trial aims and phase. In this case the study is defined as <\/span><b>uncontrolled or single-arm trial.<\/b><\/p><p><span style=\"font-weight: 400;\">To avoid undue researcher influences in the assessment of the intervention\u2019s effect, and\/or the reporting of patients\u2019 symptoms and outcomes, allocation to the intervention or control arms can be blinded or masked. If neither the doctor nor the patient know the allocation arm \u2013 the clinical trial is called \u201cdouble blind\u201d or \u201cdouble masked\u201d. On the opposite, in open-label trials everybody (researchers and participants) are aware of the allocation arm.\u00a0<\/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-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\">Types of clinical trials\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;\">Clinical trials allow to compare a new therapy (experimental) with another already used in clinical practice (control) to treat the health condition under study. These are called <\/span><b>controlled clinical trials<\/b><span style=\"font-weight: 400;\">. In some situations, the experimental therapy is not new and has already been approved for other health conditions; in other cases, for which no standard is available, the control therapy could be a placebo, which is the use of an inactive substance. In controlled clinical trials patients are then allocated to the group receiving the new therapy (experimental group) or to the group receiving the control therapy (control group). Researchers often use the term \u201carm\u201d to define these groups of patients. When allocation is performed at random (by chance, like flipping a coin) the studies are called<\/span><b> randomized controlled trials<\/b><span style=\"font-weight: 400;\">. Random allocation is aimed at forming groups that are similar, so that the differences between the two groups on final outcomes are due to the different interventions received and not to pre-existing differences.\u00a0<\/span><\/p><p><span style=\"font-weight: 400;\">Some clinical trials test the new intervention without making comparisons. This depends on trial aims and phase. In this case the study is defined as <\/span><b>uncontrolled or single-arm trial.<\/b><\/p><p><span style=\"font-weight: 400;\">To avoid undue researcher influences in the assessment of the intervention\u2019s effect, and\/or the reporting of patients\u2019 symptoms and outcomes, allocation to the intervention or control arms can be blinded or masked. If neither the doctor nor the patient know the allocation arm \u2013 the clinical trial is called \u201cdouble blind\u201d or \u201cdouble masked\u201d. On the opposite, in open-label trials everybody (researchers and participants) are aware of the allocation arm.\u00a0<\/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-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\">Study protocol. Ethics Committee and informed consent \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;\">When conducting a clinical study, researchers must always follow a written plan, also called \u201cstudy protocol\u201d. The protocol is defined before starting the study and provides a detailed description of the objectives, design, methodology, organization and conduction of the study.<\/span><\/p><p><span style=\"font-weight: 400;\">Every clinical study has to be approved by an Ethics Committee<\/span><span style=\"font-weight: 400;\">\u00a0before staring patient enrolment. The Ethics Committee is a multidisciplinary group of experts that evaluates the research protocol from the scientific and ethical points of view.\u00a0<\/span><\/p><p><span style=\"font-weight: 400;\">In order to decide participation in a clinical study, a patient must receive a document describing all the trial information from his\/her doctor and, if the patient voluntarily decides to participate, she\/he must sign and date the informed consent form. see <a href=\"https:\/\/dart.datariverweb.com\/iEnter\/?p=549\">Informed consent<\/a><\/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-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\">Phases of clinical trials\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;\">A new drug undergoes several testing phases during its clinical development process. If the drug proves to have an acceptable level of toxicity in relation to the expected benefit in one phase, then the subsequent trial phase can be initiated.<\/span><\/p>\n<p><span style=\"font-weight: 400;\">Each phase has a different focus:<\/span><\/p>\n<p><span style=\"font-weight: 400;\">Phase I trials test if a new therapy is harmless and answer the question: \u201cIs it safe?\u201d These studies are usually conducted on a limited number of healthy volunteers. However, certain Phase 1 trials (as happens in oncology) focus on patients rather than healthy people. The main objective is to assess potential treatments side effects and where and how they appear.<\/span><\/p>\n<p><span style=\"font-weight: 400;\">Phase II trials test the therapeutic activity of the treatment (i.e. its ability to produce the desired effects on the human body) and answer the question: \u201cWhat is its effect?\u201d They are conducted on a larger group of participants, healthy persons or patients.<\/span><\/p>\n<p><span style=\"font-weight: 400;\">Phase III trials test the efficacy of the new treatment and they answer the question \u201cDoes it work?\u201d In this phase, the new treatment is compared with the standard one or with a placebo to test its efficacy and side effects, usually through a randomised controlled trial in selected patient groups.\u00a0<\/span><\/p>\n<p><span style=\"font-weight: 400;\">Phase IV trials take place when the drug has been approved by the regulatory agencies and is available on the market. The purpose of this phase is to find more information about long-term benefits and side effects in widespread use in clinical practice. They answer the question \u201cDoes it work in clinical practice?\u201d.<\/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\">Basket trials\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;\">Basket trials are a new type of clinical trials focused on the treatment of cancer patients carrying a specific genetic mutation or molecular profile, for the purpose of evaluating a targeted therapy. Basket trials often use a methodological approach called \u201csingle-arm\u201d, which is the evaluation of the efficacy of a drug without using a comparator<\/span><span style=\"font-weight: 400;\">.<\/span><span style=\"font-weight: 400;\">To know more about clinical studies, watch the short animated film designed and produced within the EU- funded ECRAN project: <\/span><b>https:\/\/vimeo.com\/69337236.<\/b><\/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-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\">Clinical trials: important things to know\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;\">\u201cNew treatments\u201d are not necessarily better than standard ones in terms of efficacy and safety.<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Patients should be selected for a clinical trial if they are likely to benefit the most from the new treatment.<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">For ethical reasons, placebo control groups are not allowed if a standard treatment already exists and patients can benefit from it. In such cases, the best standard treatment available must be used as a control.<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Clinical trials are ruled by international guidelines and legislation to protect participants and ensure their safety.\u00a0<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Before conducting clinical trials involving patients, several studies (usually classified into \u201cphases\u201d) need to be carried out in the labs \u2013 within laboratory research and preclinical research. If these studies provide satisfactory findings, the drug is tested in clinical trials. The ultimate aim of a clinical trial is to move findings from bench to bedside, translating the research conducted in laboratories into concrete ways of helping patients.\u00a0<\/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\">How can I find the right clinical trial for me?\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;\">If you are considering taking part in a clinical trial, the first and easiest step is to ask your doctor, who is aware of your disease condition, knows all about your tests\u2019 results, and will be able to refer you to the most suitable trials in local hospitals, research centres or universities.<\/span><\/p>\n<p><span style=\"font-weight: 400;\">Meeting other people who have been diagnosed with the same condition is also useful to gather information. Patients\u2019 associations are usually very helpful and you can directly consult their websites.\u00a0<\/span><\/p>\n<p><span style=\"font-weight: 400;\">You can also directly browse the clinical trial registers that collect clinical studies conducted around the world (<\/span><a href=\"https:\/\/www.clinicaltrials.gov\/\"><span style=\"font-weight: 400;\">https:\/\/www.clinicaltrials.gov\/<\/span><\/a><span style=\"font-weight: 400;\"> ) or clinical trials conducted at the European level (<\/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;\">.). For each study, you can read a summary of the study protocol and find out study locations and specific contact information. If you find a clinical trial in which you might be interested in, the best thing to do is to talk with your doctor.<\/span><\/p>\n<p><span style=\"font-weight: 400;\">In any case, always go through the whole informed consent process before taking your final decision. Even though this might be a time-consuming process, it is essential to make sure you fully understand what you are signing up for.<\/span><\/p>\n<p><span style=\"font-weight: 400;\">Source: ECRAN &#8211; European Communication on Research Awareness Needs \u2013 project funded by European Union\u2019s Seventh Framework Programme.<\/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>Medical practice is based on preventive, diagnostic and therapeutic interventions, whose efficacy (benefits) and safety (absence of unwanted effects) must be proven through rigorous medical research.<br \/>\nWhile pre-clinical research is medical research carried out in a laboratory, without direct patient involvement and is aimed at collecting preliminary safety and efficacy data, clinical research involves people in so called \u201cclinical studies\u201d and is aimed at evaluating efficacy and safety of therapeutic interventions in the clinical setting. <\/p>\n","protected":false},"author":5,"featured_media":2802,"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":[77,34],"tags":[],"class_list":["post-2636","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-clinical","category-trials"],"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\/2636","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=2636"}],"version-history":[{"count":41,"href":"https:\/\/dart.datariverweb.com\/iEnter\/index.php?rest_route=\/wp\/v2\/posts\/2636\/revisions"}],"predecessor-version":[{"id":3580,"href":"https:\/\/dart.datariverweb.com\/iEnter\/index.php?rest_route=\/wp\/v2\/posts\/2636\/revisions\/3580"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/dart.datariverweb.com\/iEnter\/index.php?rest_route=\/wp\/v2\/media\/2802"}],"wp:attachment":[{"href":"https:\/\/dart.datariverweb.com\/iEnter\/index.php?rest_route=%2Fwp%2Fv2%2Fmedia&parent=2636"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/dart.datariverweb.com\/iEnter\/index.php?rest_route=%2Fwp%2Fv2%2Fcategories&post=2636"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/dart.datariverweb.com\/iEnter\/index.php?rest_route=%2Fwp%2Fv2%2Ftags&post=2636"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}