{"id":3571,"date":"2020-08-12T15:48:32","date_gmt":"2020-08-12T14:48:32","guid":{"rendered":"http:\/\/med.st-andrews.ac.uk\/tbtrials\/?page_id=3571"},"modified":"2025-03-24T11:00:39","modified_gmt":"2025-03-24T11:00:39","slug":"clinicaltrials","status":"publish","type":"page","link":"https:\/\/medicine.st-andrews.ac.uk\/tbtrials\/clinicaltrials\/","title":{"rendered":"Clinical Trials"},"content":{"rendered":"

[et_pb_section fb_built=”1″ admin_label=”Clinical Trials Front Page” _builder_version=”4.16″ _module_preset=”default” transform_translate=”0px|-68px” transform_translate_linked=”off” width=”100%” custom_margin=”250px||||false|false” custom_padding=”||0px||false|false” box_shadow_style=”preset1″ box_shadow_spread=”-32px” collapsed=”off” global_colors_info=”{}”][et_pb_row admin_label=”Row – Intro” _builder_version=”4.27.4″ _module_preset=”default” transform_translate=”0px|-65px” transform_translate_linked=”off” max_width=”none” custom_margin=”50px||||false|false” global_colors_info=”{}”][et_pb_column type=”4_4″ _builder_version=”4.16″ _module_preset=”default” global_colors_info=”{}”][et_pb_text admin_label=”Txt – Heading” _builder_version=”4.16″ _module_preset=”default” global_colors_info=”{}”]<\/p>\n

Tuberculosis Clinical Trials<\/span><\/h1>\n

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The phases of clinical research are the stages in which scientists conduct experiments with a health intervention to obtain evidence for a process considered effective as a medical treatment. Clinical research is conducted on drug candidates, vaccine candidates, new medical devices, and new diagnostic assays. TB clinical trials can generally fall into two category: interventional (drug) trials<\/strong> and diagnostic trials<\/strong>.<\/p>\n

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Interventional (drug) Trials<\/h2>\n

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Drug development begins in preclinical studies where researchers find out about the safety and biological efficacy of a drug candidate before testing it in human population. Pre-clinical studies are usually performed in research laboratories by scientists using models that mocks the environment the drug is intended to act on its target. Animal models are also used in the final stage of preclinical research.<\/p>\n

The clinical phases start with testing for safety in a few human subjects, then expand to many study participants (potentially tens of thousands) to determine if the treatment is effective. In interventional trials a new pharmaceutical intervention is tested \u2013 such as a new antibiotic or a new drug regimen with prospective benefits over the currently used therapy. The most common interventional trials in TB are those testing new combination of TB drugs that can shorten the duration of therapy from 6 months to an aimed 4 months or less. For drug development, the clinical phases start with testing for safety in a few human subjects, then expand to many study participants (potentially tens of thousands) to determine if the treatment is effective.<\/p>\n

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Phases of an interventional clinical trial<\/h2>\n

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Diagnostic trials<\/h2>\n

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Diagnostic trials have a crucial role in breaking the trajectory of the TB epidemic reaching the global targets of a world free of tuberculosis. One of the three pillars of the WHO established End TB strategy<\/a> is supporting and prioritising the research of new diagnostics. There is a high need for better diagnostic tools in TB which can substitute the current laboratory methods which are labour intensive and time consuming. Our team has a profound expertise in developing and evaluating new tools for diagnosing TB, which is frequently incorporated into the Ph.D. projects of our enthusiastic researchers. Over the years we have invented new tools for easier and faster detection of M. tuberculosis<\/em> which methods can be implemented in clinical trials and everyday clinical practice.<\/p>\n

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SimpliciTB is a multi-centre phase 3 clinical trial evaluating a new shorter drug regimen (all-oral BPaMZ) in drug susceptible and resistant pulmonary tuberculosis across 4 continents led by TB Alliance (insert html link to TBA SimpliciTB webpage).<\/p>\r\n

The trial started in 2018 and the\u00a0European and Developing Countries Clinical Trials Partnership<\/a>\u00a0(EDCTP) has recently awarded 12 million euro for the execution of the trial in sub-Saharan Africa. It also include capacity building funding that will enhance clinical research in these settings.<\/p>\r\n

The University of St Andrews will coordinate the grant and lead medical monitoring, and the TB Alliance will work with PanACEA clinical research sites of\u00a0PanACEA<\/a>\u00a0to deliver the trial.<\/p>\r\n

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A new treatment combination<\/h2>\r\n

Tuberculosis causes about a million deaths every year. To change this and save lives, new tools, especially better treatments, are required.<\/p>\r\n

According to the World Health Organization\u2019s most recent Global Tuberculosis Report, there is growing resistance to available drugs, which means the disease is becoming more deadly and more difficult to treat: current drugs for resistant infections are less effective and more toxic.<\/p>\r\n

The new study, SimpliciTB initiated by TB Alliance, will test a very promising new treatment combination in patients with both susceptible and multiple drug resistant infection. 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Medical Monitors<\/h2>\r\n

The Medical Monitoring team from University of St Andrews and South Africa assist site investigators to apply appropriate criteria for patient recruitment. Monitors are also available to discuss individual cases where the interpretation of the protocol is unclear.<\/p>\r\n

Medical monitors<\/p>\r\n