{"id":3630,"date":"2020-09-02T14:09:06","date_gmt":"2020-09-02T14:09:06","guid":{"rendered":"http:\/\/wordpress.mytomorrows.com\/?p=3630"},"modified":"2024-02-27T13:26:53","modified_gmt":"2024-02-27T13:26:53","slug":"post-trial-access-treatment-how-expanded-access-may-offer-strategic-solution","status":"publish","type":"post","link":"https:\/\/main-portal.develop-mytomorrows.com\/ar\/blog\/biopharma\/post-trial-access-treatment-how-expanded-access-may-offer-strategic-solution\/","title":{"rendered":"Post-Trial Access to Treatment: How Expanded Access May Offer A Strategic Solution"},"content":{"rendered":"<div class=\"ng-star-inserted\">\n<div id=\"\" class=\"blogpost__block blogpost__text ng-star-inserted\">\n<p>Within the development process of each drug, it is essential to realize that when clinical studies end, it affects not only the patients who volunteer to participate in a Clinical Trial but also the pharmaceutical company, and thus companies must plan ahead for the implications of Clinical Trial closure or completion from multiple angles.<\/p>\n<p>\u201cPost-Trial Access\u201d (PTA) refers to the provision of a product, either investigational treatment or comparator, to Clinical Trial participants following trial completion. Post-trial access may involve open-label trial extension studies, long-term extension studies, rollover clinical studies, separate protocols, or protocol amendments.<\/p>\n<p>All phases of clinical research are highly regulated; however, the regulations for continuing to treat a patient after a Clinical Trial ends (post-trial) are unclear or nonexistent.<\/p>\n<p>The lack of firm guidance and over-arching frameworks for PTA creates a need for equitable solutions for all stakeholders involved.\u00a0<a href=\"https:\/\/www.nytimes.com\/2019\/03\/22\/well\/mind\/alzheimers-drug-trial-study-biogen-dementia-treatment-cure.html\">Ongoing pressure from patients<\/a>\u00a0over the entire course of their journey has exposed a need to adequately consider the provision of a drug for continued treatment of those who have participated in a Clinical Trial, while also engaging in a proactive and patient-friendly manner[1].<\/p>\n<p>Consequently, companies are increasingly looking for other access pathways to continue with the provision of treatment while also trying to explore new opportunities to collect treatment-related data to inform regulatory decision-making.<\/p>\n<\/div>\n<\/div>\n<div class=\"ng-star-inserted\">\n<div id=\"Declaration of Helsinki Post-Trial Access\" class=\"blogpost__block blogpost__text ng-star-inserted\">\n<h3><strong>Declaration of Helsinki Post-Trial Access<\/strong><\/h3>\n<p>Historically, drug companies have relied on international ethical frameworks such as the Declaration of Helsinki, the ICH Good Clinical Practices, and other international guidelines such as CIOMS10 and UNESCO\u2019s Universal Declaration on Bioethics and Human Rights because there are not many country-specific regulations.<\/p>\n<p>The Good Clinical Practice (GCP) Guidelines describe the responsibilities and expectations of those involved in the conduct of Clinical Trials. Unfortunately, the GCP guidelines do not describe any responsibilities for continuing treatment after a trial.<\/p>\n<p>However, paragraph 34 of the\u00a0<a href=\"https:\/\/www.wma.net\/policies-post\/wma-declaration-of-helsinki-ethical-principles-for-medical-research-involving-human-subjects\/\">Declaration of Helsinki<\/a>\u00a0draws focus to post-trial responsibilities.<\/p>\n<p><i>\u201cIn advance of a clinical trial, sponsors, researchers, and host country governments should make provisions for post-trial access for all participants who still need an intervention identified as beneficial in the trial. This information must also be disclosed to participants during the informed consent process.\u201d<\/i><\/p>\n<p>The Council for International Organizations of Medical Sciences (CIOMS), in collaboration with the World Health Organization (WHO), states in its\u00a0<i>International Ethical Guidelines for Biomedical Research Involving Human Subjects<\/i>\u00a0that companies should consider the following:<\/p>\n<p><i>\u201cWhether, when, and how any products or interventions proven by the research to be safe and effective will be made available to subjects after they have completed their participation in the research, and whether they will be expected to pay for them\u2026\u201d<\/i><\/p>\n<p>These two ethical frameworks provided some guidance concerning the topic but left many questions unanswered.<\/p>\n<\/div>\n<\/div>\n<div class=\"ng-star-inserted\">\n<div id=\"CIOMS revisions and FDA, EMA on Post-Trial Access\" class=\"blogpost__block blogpost__text ng-star-inserted\">\n<h3><strong>CIOMS revisions and FDA, EMA on Post-Trial Access<\/strong><\/h3>\n<p>In 2016, CIOMS released a revised version of its\u00a0<a href=\"https:\/\/cioms.ch\/publications\/product\/international-ethical-guidelines-for-health-related-research-involving-humans\/\"><i>Ethical Guidelines for Biomedical Research<\/i><\/a><i>.<\/i><\/p>\n<p>Among other suggestions, the draft guideline recommends that researchers and sponsors must make provision for:<\/p>\n<ul>\n<li>Providing continued access to study interventions that have demonstrated significant benefits; and<\/li>\n<li>Consulting with other relevant stakeholders, if any, to determine everyone\u2019s responsibilities and the conditions under which participants will receive continued access to an investigational drug that has demonstrated significant benefit in the study.<\/li>\n<\/ul>\n<p>The CIOMS revisions also gave examples of valid reasons for ending Post-Trial Access(PTA), such as a pre-determined period for treatment provision or the local availability of other treatment options (approved drugs or other clinical research). Upfront communication before a trial commencement was also suggested.<\/p>\n<p>With these revisions, it is clear that the ideals of the Declaration of Helsinki have shaped current practice, mostly stipulating that access is to be provided after the research to investigational interventions that have demonstrated significant benefit.<\/p>\n<p>In the U.S., the topic has also gained recent traction. As a result, the\u00a0<a href=\"https:\/\/www.fda.gov\/news-events\/press-announcements\/statement-fda-commissioner-scott-gottlieb-md-director-fdas-center-drug-evaluation-and-research-janet\">FDA<\/a>\u00a0is actively encouraging drug developers to consider Expanded Access (EA) as this could be very appropriate in many case-specific situations. It stated that:<\/p>\n<p>\u201c<i>If the purpose is primarily to provide the drug to patients who continue to need it, an EA program may be used for either moderately sized populations (intermediate EA) or large size populations (treatment EA), often when most studies in support of approval have been completed.\u201d<\/i><\/p>\n<p><i>\u201cEA is generally available when clinical trial results show that the drug is effective in the studied population. However, sometimes drugs that have not shown benefit across the overall study population may still be providing benefit for individual patients.\u201d<\/i><\/p>\n<p>The latter statement resonates with the Declaration of Helsinki but also advocates a clear role for Expanded Access.<\/p>\n<p>In Europe, Clinical Trial sponsors are required to describe PTA for trial participants with respect to the local regulations. Other countries, such as Brazil, also require PTA commitments from the drug developer before a trial starts.<\/p>\n<p>However, a lack of clarity still makes it challenging for drug companies to interpret some of the regulatory and ethical guidance available to them.<\/p>\n<ul>\n<li>Firstly, neither the Declaration of Helsinki nor CIOMS define how one determines whether an intervention or drug is \u201cbeneficial\u201d, and under what circumstances responsibilities for stakeholders emerge.<\/li>\n<li>Secondly, both frameworks do not address how the safety (risk) of an investigational drug should be evaluated and considered.<\/li>\n<li>Finally, it is unclear what specific responsibility(ies) apply to each stakeholder with regard to PTA and how long those responsibilities last.<\/li>\n<\/ul>\n<\/div>\n<\/div>\n<div class=\"ng-star-inserted\">\n<div id=\"Open-label extension studies, Long-Term extension studies Post-Trial Access, Treatment Arms, Rollover study Clinical Trials and Phase 4 studies\" class=\"blogpost__block blogpost__text ng-star-inserted\">\n<h3><strong>Open-label extension studies, Long-Term extension studies Post-Trial Access, Treatment Arms, Rollover studies Clinical Trials, and Phase 4 studies<\/strong><\/h3>\n<p>Many country-specific regulations, including the U.S., do not explicitly address Post-Trial Access (PTA). As a result, PTA is often managed in open-label (OLE), long-term\/extension (LTE) studies, treatment arms of Clinical Trials, and more recently, Expanded Access Programs which have become the preferred choice.<\/p>\n<p>Patients who are benefiting from treatment may be enrolled in a study extension such as an open-label extension study or long-term extension study. OLE and LTE studies are often conducted to assess the long-term safety and tolerability of an investigational new drug.<\/p>\n<p>The purpose of a clinical study\u2019s treatment arm is solely for patient treatment done in a research setting but without patients receiving a placebo. This is similarly the case when rollover clinical studies are considered.<\/p>\n<p>If the intent is to gather more additional rigorous information in support of the application, which requires\u00a0<i>fundamental<\/i>\u00a0research hypotheses \u2013 OLE and LTE studies, a Clinical Trial arm or roll-over studies have proven to be more useful.<\/p>\n<p>Expanded Access could be the appropriate mechanism for patient treatment purposes if the objective is to provide the drug for treatment only.<\/p>\n<p>After approval, a Phase 4 study is referred to as post-marketing surveillance and as the name suggests, is conducted after the drug is already approved and available to the general public.<\/p>\n<p>To understand the nuances between various pathways that are currently used, we summarized an overview in the following table:<\/p>\n<\/div>\n<\/div>\n<div class=\"ng-star-inserted\">\n<div class=\"blogpost__block blogpost__image ng-star-inserted\">\n<figure><img decoding=\"async\" src=\"https:\/\/cdn.mytomorrows.com\/media\/original_images\/PTA_1.jpg\" alt=\"\" \/><\/figure>\n<\/div>\n<\/div>\n<div class=\"ng-star-inserted\">\n<div id=\"\" class=\"blogpost__block blogpost__text ng-star-inserted\">\n<p><i>Comparison table between Open-Label Extension Study, Post-Trial Access (Under EA), and Phase IV Study<\/i><\/p>\n<\/div>\n<\/div>\n<div class=\"ng-star-inserted\">\n<div id=\"Post-Trial Access through Expanded Access\" class=\"blogpost__block blogpost__text ng-star-inserted\">\n<h3><strong>Post-Trial Access through Expanded Access<\/strong><\/h3>\n<p>Over the past several years, the increasing popularity of Expanded Access has moved beyond its treatment-only focus within emergency use towards helping larger groups of patients. In addition, Expanded Access Programs (EAP) have had no-to-minimal data collection requirements other than pharmacovigilance. More recently,\u00a0<a href=\"https:\/\/main-portal.develop-mytomorrows.com\/en\/blog\/expanded-access-as-a-source-of-realworld-data\">Real-World Data collection within Expanded Access<\/a>\u00a0has become part of a new strategic imperative for drug developers and has increased focus on data collection opportunities outside the realms of an interventional research study.<\/p>\n<p>Although the use of Expanded Access for Post-Trial Access (PTA) is gaining traction, it remains fairly underutilized. Typically, an EAP is designed to run alongside different phases of Trials to manage more than PTA and is designed for patients who:<\/p>\n<ul>\n<li>Are not able to access a Clinical Trial site or ineligible for trial<\/li>\n<li>Have completed trial participation or trial has ended<\/li>\n<li>Have shown benefit from treatment with a trial drug<\/li>\n<\/ul>\n<p>Post-trial access for a potential patient may be conducted through Expanded Access when a trial has been closed (For reasons other than safety reasons):<\/p>\n<ul>\n<li>The patient has shown benefit from treatment<\/li>\n<li>There is a potential negative consequence if the patient stops treatment<\/li>\n<\/ul>\n<\/div>\n<\/div>\n<div class=\"ng-star-inserted\">\n<div id=\"Considerations for drug developers\" class=\"blogpost__block blogpost__text ng-star-inserted\">\n<h3><strong>Considerations for drug developers<\/strong><\/h3>\n<p>Inevitably Clinical Trials remain the most important part of the development and registration of innovative products, as they enable the collection of robust safety and efficacy data on investigational products to support regulatory approval.<\/p>\n<p>Before choosing the pathway for Post-Trial Access (PTA) considerations, here are some recommendations summarized for drug developers:<\/p>\n<ul>\n<li>Describe PTA provision in all the Clinical Trial Protocols<\/li>\n<li>Communicate clearly the PTA policy on their company website<\/li>\n<li>Develop patient-friendly communications for PTA policy and seek patient input<\/li>\n<li>Write a separate section in the related patient informed consent forms (ICF), so that patients are fully aware prior to agreeing to participate in a research study<\/li>\n<li>Provide upfront disclosure to regulatory authorities and ethical committees about the company\u2019s PTA plans, prior to protocol development and patient enrollment<\/li>\n<\/ul>\n<p>Explore the treatment-related data collection opportunities<\/p>\n<p>Other areas that need some preparation as well include:<\/p>\n<ul>\n<li>Understanding patient-specific factors, e.g. duration of treatment<\/li>\n<li>Moment of treatment cycle and longer-term supply considerations<\/li>\n<li>Potential patient benefit derived from a product vs. other available treatments (including Clinical Trials) \u2013 not on a group level but on a per-patient basis<\/li>\n<li>Additional labeling requirements as well as other document amendments that may be necessary to satisfy the transition<\/li>\n<\/ul>\n<p>It is important to realize that each PTA claim will vary depending on a number of context-specific factors. PTA is not valid when the investigational treatment does\u00a0<i>not<\/i>\u00a0provide benefit over standard treatment. Furthermore, patients who advocate for early termination of a trial to obtain access need to be checked for compliance reasons.<\/p>\n<\/div>\n<\/div>\n<div class=\"ng-star-inserted\">\n<div class=\"blogpost__block blogpost__image ng-star-inserted\">\n<figure><img decoding=\"async\" src=\"https:\/\/cdn.mytomorrows.com\/media\/original_images\/PTA_2.jpg\" alt=\"\" \/><\/figure>\n<\/div>\n<\/div>\n<div class=\"ng-star-inserted\">\n<div id=\"\" class=\"blogpost__block blogpost__text ng-star-inserted\">\n<p><i>Post-Trial Access Decision Tree<\/i><\/p>\n<\/div>\n<\/div>\n<div class=\"ng-star-inserted\">\n<div id=\"Conclusion\" class=\"blogpost__block blogpost__text ng-star-inserted\">\n<h3><strong>Conclusion<\/strong><\/h3>\n<p>The Declaration of Helsinki provides a very high-level idea of what is needed for Post-Trial considerations. Although some revisions and new suggestions from regulatory authorities have been made, it remains challenging to understand how to develop a clinical development strategy while carefully taking into consideration the needs of patients when Clinical Trials end.<\/p>\n<p>Despite this, companies have an important duty and moral obligation to help those who take part in drug development. Companies need to treat participants with respect by acknowledging the importance of their contribution to clinical research and promoting dignity throughout trials, especially when they end.<\/p>\n<p>Companies should aim to develop policies that provide reassurance to Clinical Trial participants that the end of the Clinical Trial does not necessarily mean an end to treatment. Pharmaceutical companies need to embrace these developments by further increasing their understanding of how to plan for and execute their Post-Trial Access needs, and whether Expanded Access may offer strategic solutions.<\/p>\n<\/div>\n<\/div>\n<div class=\"ng-star-inserted\">\n<div id=\"\" class=\"blogpost__block blogpost__text ng-star-inserted\">\n<p><a href=\"\/contact-us\/\">Please contact us<\/a>\u00a0if you have additional questions<\/p>\n<\/div>\n<\/div>\n","protected":false},"excerpt":{"rendered":"<p>Expanded Access is a pathway that can be used to facilitate Post-Trial access. Open label studies and long term extension studies should only be used in research settings.<\/p>\n","protected":false},"author":12,"featured_media":4829,"comment_status":"closed","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"inline_featured_image":false,"footnotes":""},"categories":[50],"tags":[108,182,183],"class_list":["post-3630","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-biopharma","tag-clinical-trials","tag-post-trial-access","tag-regulatory"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO Premium plugin v22.5 (Yoast SEO v25.3.1) - https:\/\/yoast.com\/wordpress\/plugins\/seo\/ -->\n<title>Post-Trial Access to Treatment: How Expanded Access May Offer A Strategic Solution - myTomorrows<\/title>\n<meta name=\"robots\" content=\"noindex, follow\" \/>\n<meta property=\"og:locale\" content=\"ar_AR\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Post-Trial Access to Treatment: How Expanded Access May Offer A Strategic Solution\" \/>\n<meta property=\"og:description\" content=\"Expanded Access is a pathway that can be used to facilitate Post-Trial access. Open label studies and long term extension studies should only be used in research settings.\" \/>\n<meta property=\"og:url\" content=\"https:\/\/main-portal.develop-mytomorrows.com\/ar\/blog\/biopharma\/post-trial-access-treatment-how-expanded-access-may-offer-strategic-solution\/\" \/>\n<meta property=\"og:site_name\" content=\"myTomorrows\" \/>\n<meta property=\"article:published_time\" content=\"2020-09-02T14:09:06+00:00\" \/>\n<meta property=\"article:modified_time\" content=\"2024-02-27T13:26:53+00:00\" \/>\n<meta property=\"og:image\" content=\"https:\/\/main-portal.develop-mytomorrows.com\/wp-content\/uploads\/2020\/09\/shutterstock_212743045-e1705678585727.jpg\" \/>\n\t<meta property=\"og:image:width\" content=\"1185\" \/>\n\t<meta property=\"og:image:height\" content=\"931\" \/>\n\t<meta property=\"og:image:type\" content=\"image\/jpeg\" \/>\n<meta name=\"author\" content=\"Dennis Akkaya\" \/>\n<meta name=\"twitter:card\" content=\"summary_large_image\" \/>\n<meta name=\"twitter:label1\" content=\"\u0643\u064f\u062a\u0628 \u0628\u0648\u0627\u0633\u0637\u0629\" \/>\n\t<meta name=\"twitter:data1\" content=\"Dennis Akkaya\" \/>\n\t<meta name=\"twitter:label2\" content=\"\u0648\u0642\u062a \u0627\u0644\u0642\u0631\u0627\u0621\u0629 \u0627\u0644\u0645\u064f\u0642\u062f\u0651\u0631\" \/>\n\t<meta name=\"twitter:data2\" content=\"9 \u062f\u0642\u0627\u0626\u0642\" \/>\n<script type=\"application\/ld+json\" class=\"yoast-schema-graph\">{\"@context\":\"https:\/\/schema.org\",\"@graph\":[{\"@type\":\"WebPage\",\"@id\":\"https:\/\/main-portal.develop-mytomorrows.com\/ar\/blog\/biopharma\/post-trial-access-treatment-how-expanded-access-may-offer-strategic-solution\/\",\"url\":\"https:\/\/main-portal.develop-mytomorrows.com\/ar\/blog\/biopharma\/post-trial-access-treatment-how-expanded-access-may-offer-strategic-solution\/\",\"name\":\"Post-Trial Access to Treatment: How Expanded Access May Offer A Strategic Solution - myTomorrows\",\"isPartOf\":{\"@id\":\"https:\/\/main-portal.develop-mytomorrows.com\/ar\/#website\"},\"primaryImageOfPage\":{\"@id\":\"https:\/\/main-portal.develop-mytomorrows.com\/ar\/blog\/biopharma\/post-trial-access-treatment-how-expanded-access-may-offer-strategic-solution\/#primaryimage\"},\"image\":{\"@id\":\"https:\/\/main-portal.develop-mytomorrows.com\/ar\/blog\/biopharma\/post-trial-access-treatment-how-expanded-access-may-offer-strategic-solution\/#primaryimage\"},\"thumbnailUrl\":\"https:\/\/main-portal.develop-mytomorrows.com\/wp-content\/uploads\/2020\/09\/shutterstock_212743045-e1705678585727.jpg\",\"datePublished\":\"2020-09-02T14:09:06+00:00\",\"dateModified\":\"2024-02-27T13:26:53+00:00\",\"author\":{\"@id\":\"https:\/\/main-portal.develop-mytomorrows.com\/ar\/#\/schema\/person\/b7be59ac2b5f8aea751c2b85d116402e\"},\"breadcrumb\":{\"@id\":\"https:\/\/main-portal.develop-mytomorrows.com\/ar\/blog\/biopharma\/post-trial-access-treatment-how-expanded-access-may-offer-strategic-solution\/#breadcrumb\"},\"inLanguage\":\"ar\",\"potentialAction\":[{\"@type\":\"ReadAction\",\"target\":[\"https:\/\/main-portal.develop-mytomorrows.com\/ar\/blog\/biopharma\/post-trial-access-treatment-how-expanded-access-may-offer-strategic-solution\/\"]}]},{\"@type\":\"ImageObject\",\"inLanguage\":\"ar\",\"@id\":\"https:\/\/main-portal.develop-mytomorrows.com\/ar\/blog\/biopharma\/post-trial-access-treatment-how-expanded-access-may-offer-strategic-solution\/#primaryimage\",\"url\":\"https:\/\/main-portal.develop-mytomorrows.com\/wp-content\/uploads\/2020\/09\/shutterstock_212743045-e1705678585727.jpg\",\"contentUrl\":\"https:\/\/main-portal.develop-mytomorrows.com\/wp-content\/uploads\/2020\/09\/shutterstock_212743045-e1705678585727.jpg\",\"width\":1185,\"height\":931,\"caption\":\"Scientist or tech holds liquid biological sample in gloved hands\"},{\"@type\":\"BreadcrumbList\",\"@id\":\"https:\/\/main-portal.develop-mytomorrows.com\/ar\/blog\/biopharma\/post-trial-access-treatment-how-expanded-access-may-offer-strategic-solution\/#breadcrumb\",\"itemListElement\":[{\"@type\":\"ListItem\",\"position\":1,\"name\":\"Home\",\"item\":\"https:\/\/main-portal.develop-mytomorrows.com\/ar\/home\/\"},{\"@type\":\"ListItem\",\"position\":2,\"name\":\"Post-Trial Access to Treatment: How Expanded Access May Offer A Strategic Solution\"}]},{\"@type\":\"WebSite\",\"@id\":\"https:\/\/main-portal.develop-mytomorrows.com\/ar\/#website\",\"url\":\"https:\/\/main-portal.develop-mytomorrows.com\/ar\/\",\"name\":\"myTomorrows\",\"description\":\"Helping patients discover and access treatments\",\"potentialAction\":[{\"@type\":\"SearchAction\",\"target\":{\"@type\":\"EntryPoint\",\"urlTemplate\":\"https:\/\/main-portal.develop-mytomorrows.com\/ar\/?s={search_term_string}\"},\"query-input\":{\"@type\":\"PropertyValueSpecification\",\"valueRequired\":true,\"valueName\":\"search_term_string\"}}],\"inLanguage\":\"ar\"},{\"@type\":\"Person\",\"@id\":\"https:\/\/main-portal.develop-mytomorrows.com\/ar\/#\/schema\/person\/b7be59ac2b5f8aea751c2b85d116402e\",\"name\":\"Dennis Akkaya\",\"image\":{\"@type\":\"ImageObject\",\"inLanguage\":\"ar\",\"@id\":\"https:\/\/main-portal.develop-mytomorrows.com\/ar\/#\/schema\/person\/image\/\",\"url\":\"https:\/\/secure.gravatar.com\/avatar\/08df14c0e203d864844886d2fccb5743e4e7f8312cea375e51edd4ea0803ed6f?s=96&d=blank&r=g\",\"contentUrl\":\"https:\/\/secure.gravatar.com\/avatar\/08df14c0e203d864844886d2fccb5743e4e7f8312cea375e51edd4ea0803ed6f?s=96&d=blank&r=g\",\"caption\":\"Dennis Akkaya\"},\"description\":\"Based in New York and operating from the US office, Dennis holds an MSc in Finance, has over 20 years of BioPharma industry experience, and is a recognized thought leader in pre-approval access and with specific expertise in clinical trials. Over 8 years at myTomorrows, his role is pivotal in creating biopharma sponsorships. His extensive background, encompassing both BioPharma and finance, well positions him to develop strategic partnerships and drive the discussion within the pre-approval access space.\",\"url\":\"https:\/\/main-portal.develop-mytomorrows.com\/ar\/blog\/author\/dennis-akkaya\/\"}]}<\/script>\n<!-- \/ Yoast SEO Premium plugin. -->","yoast_head_json":{"title":"Post-Trial Access to Treatment: How Expanded Access May Offer A Strategic Solution - myTomorrows","robots":{"index":"noindex","follow":"follow"},"og_locale":"ar_AR","og_type":"article","og_title":"Post-Trial Access to Treatment: How Expanded Access May Offer A Strategic Solution","og_description":"Expanded Access is a pathway that can be used to facilitate Post-Trial access. Open label studies and long term extension studies should only be used in research settings.","og_url":"https:\/\/main-portal.develop-mytomorrows.com\/ar\/blog\/biopharma\/post-trial-access-treatment-how-expanded-access-may-offer-strategic-solution\/","og_site_name":"myTomorrows","article_published_time":"2020-09-02T14:09:06+00:00","article_modified_time":"2024-02-27T13:26:53+00:00","og_image":[{"width":1185,"height":931,"url":"https:\/\/main-portal.develop-mytomorrows.com\/wp-content\/uploads\/2020\/09\/shutterstock_212743045-e1705678585727.jpg","type":"image\/jpeg"}],"author":"Dennis Akkaya","twitter_card":"summary_large_image","twitter_misc":{"\u0643\u064f\u062a\u0628 \u0628\u0648\u0627\u0633\u0637\u0629":"Dennis Akkaya","\u0648\u0642\u062a \u0627\u0644\u0642\u0631\u0627\u0621\u0629 \u0627\u0644\u0645\u064f\u0642\u062f\u0651\u0631":"9 \u062f\u0642\u0627\u0626\u0642"},"schema":{"@context":"https:\/\/schema.org","@graph":[{"@type":"WebPage","@id":"https:\/\/main-portal.develop-mytomorrows.com\/ar\/blog\/biopharma\/post-trial-access-treatment-how-expanded-access-may-offer-strategic-solution\/","url":"https:\/\/main-portal.develop-mytomorrows.com\/ar\/blog\/biopharma\/post-trial-access-treatment-how-expanded-access-may-offer-strategic-solution\/","name":"Post-Trial Access to Treatment: How Expanded Access May Offer A Strategic Solution - myTomorrows","isPartOf":{"@id":"https:\/\/main-portal.develop-mytomorrows.com\/ar\/#website"},"primaryImageOfPage":{"@id":"https:\/\/main-portal.develop-mytomorrows.com\/ar\/blog\/biopharma\/post-trial-access-treatment-how-expanded-access-may-offer-strategic-solution\/#primaryimage"},"image":{"@id":"https:\/\/main-portal.develop-mytomorrows.com\/ar\/blog\/biopharma\/post-trial-access-treatment-how-expanded-access-may-offer-strategic-solution\/#primaryimage"},"thumbnailUrl":"https:\/\/main-portal.develop-mytomorrows.com\/wp-content\/uploads\/2020\/09\/shutterstock_212743045-e1705678585727.jpg","datePublished":"2020-09-02T14:09:06+00:00","dateModified":"2024-02-27T13:26:53+00:00","author":{"@id":"https:\/\/main-portal.develop-mytomorrows.com\/ar\/#\/schema\/person\/b7be59ac2b5f8aea751c2b85d116402e"},"breadcrumb":{"@id":"https:\/\/main-portal.develop-mytomorrows.com\/ar\/blog\/biopharma\/post-trial-access-treatment-how-expanded-access-may-offer-strategic-solution\/#breadcrumb"},"inLanguage":"ar","potentialAction":[{"@type":"ReadAction","target":["https:\/\/main-portal.develop-mytomorrows.com\/ar\/blog\/biopharma\/post-trial-access-treatment-how-expanded-access-may-offer-strategic-solution\/"]}]},{"@type":"ImageObject","inLanguage":"ar","@id":"https:\/\/main-portal.develop-mytomorrows.com\/ar\/blog\/biopharma\/post-trial-access-treatment-how-expanded-access-may-offer-strategic-solution\/#primaryimage","url":"https:\/\/main-portal.develop-mytomorrows.com\/wp-content\/uploads\/2020\/09\/shutterstock_212743045-e1705678585727.jpg","contentUrl":"https:\/\/main-portal.develop-mytomorrows.com\/wp-content\/uploads\/2020\/09\/shutterstock_212743045-e1705678585727.jpg","width":1185,"height":931,"caption":"Scientist or tech holds liquid biological sample in gloved hands"},{"@type":"BreadcrumbList","@id":"https:\/\/main-portal.develop-mytomorrows.com\/ar\/blog\/biopharma\/post-trial-access-treatment-how-expanded-access-may-offer-strategic-solution\/#breadcrumb","itemListElement":[{"@type":"ListItem","position":1,"name":"Home","item":"https:\/\/main-portal.develop-mytomorrows.com\/ar\/home\/"},{"@type":"ListItem","position":2,"name":"Post-Trial Access to Treatment: How Expanded Access May Offer A Strategic Solution"}]},{"@type":"WebSite","@id":"https:\/\/main-portal.develop-mytomorrows.com\/ar\/#website","url":"https:\/\/main-portal.develop-mytomorrows.com\/ar\/","name":"myTomorrows","description":"Helping patients discover and access treatments","potentialAction":[{"@type":"SearchAction","target":{"@type":"EntryPoint","urlTemplate":"https:\/\/main-portal.develop-mytomorrows.com\/ar\/?s={search_term_string}"},"query-input":{"@type":"PropertyValueSpecification","valueRequired":true,"valueName":"search_term_string"}}],"inLanguage":"ar"},{"@type":"Person","@id":"https:\/\/main-portal.develop-mytomorrows.com\/ar\/#\/schema\/person\/b7be59ac2b5f8aea751c2b85d116402e","name":"Dennis Akkaya","image":{"@type":"ImageObject","inLanguage":"ar","@id":"https:\/\/main-portal.develop-mytomorrows.com\/ar\/#\/schema\/person\/image\/","url":"https:\/\/secure.gravatar.com\/avatar\/08df14c0e203d864844886d2fccb5743e4e7f8312cea375e51edd4ea0803ed6f?s=96&d=blank&r=g","contentUrl":"https:\/\/secure.gravatar.com\/avatar\/08df14c0e203d864844886d2fccb5743e4e7f8312cea375e51edd4ea0803ed6f?s=96&d=blank&r=g","caption":"Dennis Akkaya"},"description":"Based in New York and operating from the US office, Dennis holds an MSc in Finance, has over 20 years of BioPharma industry experience, and is a recognized thought leader in pre-approval access and with specific expertise in clinical trials. Over 8 years at myTomorrows, his role is pivotal in creating biopharma sponsorships. His extensive background, encompassing both BioPharma and finance, well positions him to develop strategic partnerships and drive the discussion within the pre-approval access space.","url":"https:\/\/main-portal.develop-mytomorrows.com\/ar\/blog\/author\/dennis-akkaya\/"}]}},"_links":{"self":[{"href":"https:\/\/main-portal.develop-mytomorrows.com\/ar\/wp-json\/wp\/v2\/posts\/3630","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/main-portal.develop-mytomorrows.com\/ar\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/main-portal.develop-mytomorrows.com\/ar\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/main-portal.develop-mytomorrows.com\/ar\/wp-json\/wp\/v2\/users\/12"}],"replies":[{"embeddable":true,"href":"https:\/\/main-portal.develop-mytomorrows.com\/ar\/wp-json\/wp\/v2\/comments?post=3630"}],"version-history":[{"count":5,"href":"https:\/\/main-portal.develop-mytomorrows.com\/ar\/wp-json\/wp\/v2\/posts\/3630\/revisions"}],"predecessor-version":[{"id":5966,"href":"https:\/\/main-portal.develop-mytomorrows.com\/ar\/wp-json\/wp\/v2\/posts\/3630\/revisions\/5966"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/main-portal.develop-mytomorrows.com\/ar\/wp-json\/wp\/v2\/media\/4829"}],"wp:attachment":[{"href":"https:\/\/main-portal.develop-mytomorrows.com\/ar\/wp-json\/wp\/v2\/media?parent=3630"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/main-portal.develop-mytomorrows.com\/ar\/wp-json\/wp\/v2\/categories?post=3630"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/main-portal.develop-mytomorrows.com\/ar\/wp-json\/wp\/v2\/tags?post=3630"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}