{"id":510,"date":"2019-01-17T09:32:33","date_gmt":"2019-01-17T09:32:33","guid":{"rendered":"http:\/\/206.71.52.87\/~newwebproject\/?page_id=510"},"modified":"2019-08-13T07:12:42","modified_gmt":"2019-08-13T07:12:42","slug":"communication-and-dissemination-of-results","status":"publish","type":"page","link":"https:\/\/cdsatoolkit.thsti.in\/?page_id=510","title":{"rendered":"Communication and Dissemination of Results"},"content":{"rendered":"<div class=\"flex_column av_one_half  flex_column_div first  \" style='padding:0px 15px 0px 2px ; border-radius:0px; '><section class=\"av_textblock_section \"  itemscope=\"itemscope\" itemtype=\"https:\/\/schema.org\/CreativeWork\" ><div class='avia_textblock  '   itemprop=\"text\" ><div class=\"dfr1\"><strong>Clinical Trials Toolkit &#8211; India<\/strong><\/div>\n<\/div><\/section><\/div>\n<div class=\"flex_column av_one_half  flex_column_div   \" style='padding:0px -20px 10px 0px ; border-radius:0px; '><section class=\"av_textblock_section \"  itemscope=\"itemscope\" itemtype=\"https:\/\/schema.org\/CreativeWork\" ><div class='avia_textblock  '   itemprop=\"text\" ><div class=\"dfr\" style=\"text-align: right;\"><strong><strong>You are in: Home \/ Routemap \/ <\/strong>Communication and Dissemination of Results<\/strong><\/div>\n<\/div><\/section><\/div>\n<\/div><\/div><\/div><!-- close content main div --><\/div><\/div><div id='sdew' class='avia-section main_color avia-section-default avia-no-shadow avia-bg-style-scroll   container_wrap sidebar_right'   ><div class='container' ><div class='template-page content  av-content-small alpha units'><div class='post-entry post-entry-type-page post-entry-510'><div class='entry-content-wrapper clearfix'>\n<div class=\"flex_column av_one_fifth  flex_column_div first  \" style='padding:0px 0px 0px 12px ; 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border-radius:0px; '><div class='avia-button-wrap avia-button-right '><a href='https:\/\/cdsatoolkit.thsti.in\/?page_id=522' class='avia-button   avia-icon_select-yes-right-icon avia-color-custom avia-size-small avia-position-right '  style='background-color:#1d66a3; border-color:#1d66a3; color:#ffffff; ' ><span class='avia_iconbox_title' >Next<\/span><span class='avia_button_icon avia_button_icon_right' aria-hidden='true' data-av_icon='\ue889' data-av_iconfont='entypo-fontello'><\/span><\/a><\/div><\/div>\n<\/div><\/div><\/div><!-- close content main div --><\/div><\/div><div id='after_section_1' class='main_color av_default_container_wrap container_wrap sidebar_right'   ><div class='container' ><div class='template-page content  av-content-small alpha units'><div class='post-entry post-entry-type-page post-entry-510'><div class='entry-content-wrapper clearfix'>\n<\/div><\/div><\/div><!-- close content main div --><\/div><\/div><div id='lop1' class='avia-section main_color avia-section-default avia-no-shadow avia-bg-style-scroll   container_wrap sidebar_right'   ><div class='container' ><div class='template-page content  av-content-small alpha units'><div class='post-entry post-entry-type-page post-entry-510'><div class='entry-content-wrapper clearfix'>\n<section class=\"avia_codeblock_section  avia_code_block_0\"  itemscope=\"itemscope\" itemtype=\"https:\/\/schema.org\/CreativeWork\" ><div class='avia_codeblock '  itemprop=\"text\" > [avia_codeblock_placeholder uid=\"0\"] <\/div><\/section>\n<\/div><\/div><\/div><!-- close content main div --><\/div><\/div><div id='after_section_2' class='main_color av_default_container_wrap container_wrap sidebar_right'   ><div class='container' ><div class='template-page content  av-content-small alpha units'><div class='post-entry post-entry-type-page post-entry-510'><div class='entry-content-wrapper clearfix'>\n<\/div><\/div><\/div><!-- close content main div --><\/div><\/div><div id='nbvc' class='avia-section main_color avia-section-large avia-no-shadow avia-bg-style-scroll   container_wrap sidebar_right'   ><div class='container' ><div class='template-page content  av-content-small alpha units'><div class='post-entry post-entry-type-page post-entry-510'><div class='entry-content-wrapper clearfix'>\n<div class=\"flex_column av_two_third  flex_column_div first  \" style='padding:8px 0px 0px 14px ; border-radius:0px; '><section class=\"av_textblock_section \"  itemscope=\"itemscope\" itemtype=\"https:\/\/schema.org\/CreativeWork\" ><div class='avia_textblock  '   itemprop=\"text\" ><p style=\"text-align: justify;\">Scientific research and discovery relies on the principles of data sharing. This allows researchers to learn from others\u2019 work, identify scientific opportunities and work towards the advancement of science. Clinical trials are designed to help test new interventions, so that the community may benefit from it. Dissemination of clinical trial results (whether negative, inconclusive or positive) to the research community, the participants, and the public is a key aspect of conducting a clinical trial. The impact of not sharing the results is detrimental. Allowing data to remain unpublished leads to wastage of resources and time, as ongoing and future researchers cannot benefit from the gathered information. It also results in reporting bias which might misinform the research community.<\/p>\n<p style=\"text-align: justify;\">Information pertaining to clinical trials can be disseminated in the following ways:<\/p>\n<ul>\n<li style=\"text-align: justify;\">Trial registration: Dissemination of clinical trial results is mandatory to facilitate transparency, accountability and accessibility of trial data. The Indian Council of Medical Research (ICMR) is a signatory of the WHO Joint Statement on Public Disclosure of Results from Clinical Trials, which it adopted in May, 2017. The signatories of this statement agree that prospective registration and timely public disclosure of results from all clinical trials is of critical scientific and ethical importance and that the summary results of trials will be disclosed within one year of trial completion. The Clinical Trials Registry of India (CTRI) is currently developing a structured format for results disclosure for interventional trials. It will cover the following aspects:\n<ol>\n<li>Patient population<\/li>\n<li style=\"margin-bottom: 0px;\">Baseline characteristics<\/li>\n<li style=\"margin-bottom: 0px;\">Primary outcome<\/li>\n<li style=\"margin-bottom: 0px;\">Secondary outcome<\/li>\n<li>Adverse events<\/li>\n<\/ol>\n<\/li>\n<li style=\"text-align: justify; margin-top: -10px;\">Final Report or Clinical Study Report<\/li>\n<li style=\"text-align: justify;\">Sharing of Individual Participant Data (IPD): access to primary datasets facilitates further analysis and the overall research agenda. However, WHO\u2019s joint statement does not include IPD sharing and currently, this is not a mandatory requirement in India. However, there is an increasing acceptance of the need to share (de-identified) IPD. In recent years, various organisations (National Institutes of Health, the European Commission, Organisation for Economic Co-operation and Development) and major research funders (examples include Bill &amp; Melinda Gates Foundation and Wellcome Trust), have supported data sharing, specifically from publicly funded research. Furthermore, as of 1<sup>st<\/sup> of July 2018, manuscripts submitted to ICMJE (International Committee of Medical Journal Editors) journals which report clinical trial results, must contain a statement on plans for data sharing. ICJME policies for data sharing and trial registration can be accessed <a href=\"http:\/\/www.icmje.org\/recommendations\/browse\/publishing-and-editorial-issues\/clinical-trial-registration.html#two\" target=\"_blank\" rel=\"noopener noreferrer\">here<\/a>.<\/li>\n<\/ul>\n<h4><strong>Sharing of results with the research community <\/strong><\/h4>\n<p style=\"text-align: justify;\">Clinical trial results are shared with the research community by publishing details of trial methodology and results, in a peer reviewed scientific journal. \u00a0The trial protocol must include a publication policy. The <a href=\"http:\/\/www.consort-statement.org\/\" target=\"_blank\" rel=\"noopener noreferrer\">CONSORT<\/a> guidelines have been prepared to improve reporting practices for randomized clinical trials. Increasingly journals will insist that there are adopted and that a CONSORT checklist is completed when a manuscript is submitted. Hence it is recommended that they are followed when trial reports are drafted.<\/p>\n<p>Some other reporting guidelines that are recommended are:<\/p>\n<ul>\n<li style=\"text-align: justify;\">For meta-analyses of trial data: PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses). PRISMA resources (including a statement, checklist, flow diagrams, and an explanation and elaboration paper) are available <a href=\"http:\/\/www.prisma-statement.org\/PRISMAStatement\/Default.aspx\" target=\"_blank\" rel=\"noopener noreferrer\">here<\/a>.<\/li>\n<li style=\"text-align: justify;\">For Diagnostic \/ Prognostic Studies and Clinical Trials: STARD 2015 \u2013 An Updated List of Essential Items for Reporting Diagnostic Accuracy Studies. (Google Scholar <a href=\"https:\/\/scholar.google.co.in\/scholar?hl=en&amp;as_sdt=0%2C5&amp;q=STARD+2015&amp;btnG=\" target=\"_blank\" rel=\"noopener noreferrer\">link<\/a> to access the STARD resources).<\/li>\n<\/ul>\n<p style=\"text-align: justify;\">The Equator (Enhancing the QUAlity and Transparency Of health Research) Network is a useful resource for browsing reporting guidelines on the basis of the type of trial and study to be conducted. The Equator Network can be accessed <a href=\"https:\/\/www.equator-network.org\/reporting-guidelines\/\" target=\"_blank\" rel=\"noopener noreferrer\">here<\/a>.<\/p>\n<h4><strong>Sharing of results with the participants<\/strong><\/h4>\n<p style=\"text-align: justify;\">Informing trial participants of the overall trial results helps acknowledge their contribution to the research. In addition, where appropriate, participants must be given the choice to decide whether they would like their individual results (if they were blinded) returned to them.<\/p>\n<h4><strong>References and Further Reading<\/strong><\/h4>\n<ul style=\"margin-top: 0.5em !important;\">\n<li style=\"text-align: justify;\">Vardhana Rao, M. V., Maulik, M., Gupta, J., Panchal, Y., Juneja, A., Adhikari, T., Pandey, A., Clinical Trials Registry \u2013 India: An overview and new developments, Indian Journal of Pharmacology, 2018, vol. 50, no. 4, pages 208-211, available <a href=\"http:\/\/www.ijp-online.com\/text.asp?2018\/50\/4\/208\/244715\" target=\"_blank\" rel=\"noopener noreferrer\">online<\/a> (last accessed on 26.02.2019).<\/li>\n<li style=\"text-align: justify;\">Joint Statement on Public Disclosure of Results from Clinical Trials, available <a href=\"http:\/\/www.alltrials.net\/wp-content\/uploads\/2017\/05\/18-May-2017-joint-statement.pdf\" target=\"_blank\" rel=\"noopener noreferrer\">online<\/a> (last accessed on 26.02.2019).<\/li>\n<li style=\"text-align: justify;\">Good Clinical Practices for Clinical Research in India, Central Drugs Standard Control Organization, Ministry of Health and Family Welfare, 2001, available <a href=\"http:\/\/www.cdsco.nic.in\/html\/GCP1.html\" target=\"_blank\" rel=\"noopener noreferrer\">online<\/a> (last accessed on 26.02.2019).<\/li>\n<li style=\"text-align: justify;\">CONSORT (CONsolidated Standards Of Reporting Trials) \u2013 is an evidenced-based minimum set of recommendations for reporting randomized trials, and endorsed by prominent journals. The CONSORT resources can be accessed <a href=\"http:\/\/www.consort-statement.org\/\" target=\"_blank\" rel=\"noopener noreferrer\">here<\/a>.<\/li>\n<\/ul>\n<h4><strong>Resources for Individual Participant Data: <\/strong><\/h4>\n<ul style=\"margin-top: 0.5em !important;\">\n<li style=\"text-align: justify;\">Ohmann, C., Banzi, R., Canham, S., et al, 2017, Sharing and reuse of individual participant data from clinical trials: principles and recommendations, BMJ Open, volume 7, number 12, doi <a href=\"http:\/\/dx.doi.org\/10.1136\/bmjopen-2017-018647\" target=\"_blank\" rel=\"noopener noreferrer\">http:\/\/dx.doi.org\/10.1136\/bmjopen-2017-018647<\/a>, available <a href=\"https:\/\/bmjopen.bmj.com\/content\/7\/12\/e018647\" target=\"_blank\" rel=\"noopener noreferrer\">online<\/a> (last accessed on 07.03.2019).<\/li>\n<li style=\"text-align: justify;\">OECD Principles and Guidelines for Access to Research Data from Public Funding, 2007, Organisation for Economic Co-Operation and Development, available <a href=\"http:\/\/www.oecd.org\/science\/inno\/38500813.pdf\" target=\"_blank\" rel=\"noopener noreferrer\">online<\/a> (last accessed on 07.03.2019).<\/li>\n<li style=\"text-align: justify;\">Plan for Increasing Access to Scientific Publications and Digital Scientific Data from NIH Funded Scientific Research, National Institutes of Health, February 2015, available <a href=\"https:\/\/grants.nih.gov\/grants\/NIH-Public-Access-Plan.pdf\" target=\"_blank\" rel=\"noopener noreferrer\">online<\/a> (last accessed on 07.03.2019).<\/li>\n<li style=\"text-align: justify;\">International Committee of Medical Journal Editors (ICMJE) Recommendations for Clinical Trials (Registration and Data Sharing), available <a href=\"http:\/\/www.icmje.org\/recommendations\/browse\/publishing-and-editorial-issues\/clinical-trial-registration.html#two\" target=\"_blank\" rel=\"noopener noreferrer\">online<\/a> (last accessed on 07.03.2019).<\/li>\n<\/ul>\n<\/div><\/section><\/div><div class=\"flex_column av_one_third  flex_column_div   \" style='padding:2px 2px 0px 0px ; border-radius:0px; '><div class='avia-builder-widget-area clearfix '><div id=\"custom_html-3\" class=\"widget_text widget clearfix widget_custom_html\"><h3 class=\"widgettitle\">Key Components<\/h3><div class=\"textwidget custom-html-widget\"><div class=\"hjubv\">\r\n\t\r\n\r\n<ol style=\"margin-left: 15px !important;\">\r\n\t<li><a href=\"\/?page_id=1075\" style=\"color: #000;\">Trial Planning<\/a><\/li>\r\n\t<li><a href=\"\/?page_id=319\" style=\"color: #000;\">Trial Design<\/a><\/li>\r\n\t<li style=\"color:red !important\"><a href=\"\/?page_id=309\" style=\"color: red;\">Sponsorship<\/a><\/li>\r\n\t<li style=\"color:red !important\"><a href=\"\/?page_id=333\" style=\"color: red;\">Funding<\/a><\/li>\r\n\t<li><a href=\"\/?page_id=339\" style=\"color: #000;\">Internationally Funded Trials<\/a><\/li>\r\n\t<li><a href=\"\/?page_id=862\" style=\"color: #000;\">Trial Set-Up<\/a><\/li>\r\n\t<li style=\"color:red !important\"><a href=\"\/?page_id=343\" style=\"color: red;\">Protocol Development<\/a><\/li>\r\n\t<li style=\"color:red !important\"><a href=\"\/?page_id=345\" style=\"color: red;\">Essential Documents<\/a><\/li>\r\n<\/ol>\t\r\n<p class=\"kaw\">\r\n<ul style=\"margin-top: -23px;\">\r\n\t<li style=\"color:red !important\"><a href=\"\/?page_id=873\" style=\"color: red;\">Case Record Form<\/a><\/li>\r\n\t<li style=\"color:red !important\"><a href=\"\/?page_id=877\" style=\"color: red;\">Informed Consent Documents<\/a><\/li>\r\n\t<li style=\"color:red !important\"><a href=\"\/?page_id=880\" style=\"color: red;\">Investigator\u2019s Brochure<\/a><\/li>\r\n\t<li style=\"color:#7a7a7a !important\"><a href=\"\/?page_id=885\" style=\"color: #000;\">Trial Master File<\/a><\/li>\r\n\t<li style=\"color:#7a7a7a !important\"><a href=\"\/?page_id=363\" style=\"color: #000;\">Laboratory Related Documents<\/a><\/li>\r\n<\/ul>\r\n<\/p>\r\n<ol start=\"9\" style=\"margin-left: 15px !important;\">\r\n\t<li><a href=\"\/?page_id=419\" style=\"color: #000;\">Risk Management<\/a><\/li>\r\n\t<li><a href=\"\/?page_id=372\" style=\"color: #000;\">Quality and Process Management<\/a><\/li>\r\n<\/ol>\t\r\n<p class=\"kaw\">\r\n<ul style=\"margin-top: -23px;\">\r\n\t<li style=\"color:#7a7a7a !important\"><a href=\"\/?page_id=374\" style=\"color: #000;\">Sponsor Specific Processes and Documents<\/a><\/li>\r\n\t<li style=\"color:#7a7a7a !important\"><a href=\"\/?page_id=376\" style=\"color: #000;\">Pharmacovigilance Plan<\/a><\/li>\r\n\t<li style=\"color:#7a7a7a !important\"><a href=\"\/?page_id=378\" style=\"color: #000;\">Monitoring Plan<\/a><\/li>\r\n\t<li style=\"color:#7a7a7a !important\"><a href=\"\/?page_id=962\" style=\"color: #000;\">Safety Management Plan<\/a><\/li>\r\n\t<li style=\"color:#7a7a7a !important\"><a href=\"\/?page_id=384\" style=\"color: #000;\">Randomisation System Development and User Acceptance Testing<\/a><\/li>\r\n\t<li style=\"color:#7a7a7a !important\"><a href=\"\/?page_id=386\" style=\"color: #000;\">Database Design, Development and User Acceptance Testing<\/a> <\/li>\r\n\t<li style=\"color:#7a7a7a !important\"><a href=\"\/?page_id=355\" style=\"color: #000;\">Statistical Analysis Plan<\/a><\/li>\r\n\t<li style=\"color:#7a7a7a !important\"><a href=\"\/?page_id=380\" style=\"color: #000;\">Data Management Plan<\/a> <\/li>\r\n<\/ul>\r\n<\/p>\r\n<ol start=\"11\" style=\"margin-left: 15px !important;\">\r\n\t<li><a href=\"\/?page_id=399\" style=\"color: #000;\">Site Feasibility and Selection<\/a><\/li>\r\n<\/ol>\t\r\n<p class=\"kaw\">\r\n<ul style=\"margin-top: -23px;\">\r\n\t<li style=\"color:#7a7a7a !important\"><a href=\"\/?page_id=401\" style=\"color: #000;\">Site Identification and Evaluation<\/a><\/li>\r\n\t<li style=\"color:#7a7a7a !important\"><a href=\"\/?page_id=382\" style=\"color: #000;\">Site-specific Processes and Documents<\/a><\/li>\r\n\t<li style=\"color:red !important\"><a href=\"\/?page_id=906\" style=\"color: red;\">Clinical Trial Agreement and Investigator\u2019s Undertaking<\/a><\/li>\r\n\t<li style=\"color:#7a7a7a !important\"><a href=\"\/?page_id=409\" style=\"color: #000;\">Site Staff Training<\/a><\/li>\r\n<\/ul>\r\n<\/p>\r\n<ol start=\"12\" style=\"margin-left: 15px !important;\">\r\n\t<li><a href=\"\/?page_id=812\" style=\"color: #000;\">Trial Drug Supplies<\/a><\/li>\r\n\t<li><a href=\"\/?page_id=815\" style=\"color: #000;\">Approvals and Registration<\/a><\/li>\r\n\t<li style=\"color:red !important\"><a href=\"\/?page_id=421\" style=\"color: red;\">Regulatory Approval<\/a><\/li>\r\n    <li style=\"color:red !important\"><a href=\"\/?page_id=425\" style=\"color: red;\">Ethics Approval<\/a><\/li>\r\n\t<li style=\"color:red !important\"><a href=\"\/?page_id=852\" style=\"color: red;\">Clinical Trial Registration<\/a><\/li>\r\n\t<li><a href=\"\/?page_id=423\" style=\"color: #000;\">Other Approvals<\/a><\/li>\r\n\t<li style=\"color:red !important\"><a href=\"\/?page_id=433\" style=\"color: red;\">Final Protocol<\/a><\/li>\r\n\t<li><a href=\"\/?page_id=836\" style=\"color: #000;\">Management and Oversight Groups<\/a><\/li>\r\n\t<li><a href=\"\/?page_id=439\" style=\"color: #000;\">Trial Begins<\/a><\/li>\r\n\t<li><a href=\"\/?page_id=453\" style=\"color: #000;\">Trial Conduct<\/a><\/li>\r\n\t<li><a href=\"\/?page_id=498\" style=\"color: #000;\">Trial Close-Out<\/a><\/li>\r\n\t<li><a href=\"\/?page_id=518\" style=\"color: #000;\">Statistical Analysis and Reports<\/a><\/li>\r\n\t<li><a href=\"\/?page_id=510\" style=\"color: #000;\">Communication and Dissemination of Results<\/a><\/li>\r\n\t<li style=\"color:red !important\"><a href=\"\/?page_id=522\" style=\"color: red;\">Archiving<\/a><\/li>\r\n<\/ol>\r\n\t<\/div><\/div><\/div><div id=\"search-4\" class=\"widget clearfix widget_search\"><h3 class=\"widgettitle\">Search<\/h3>\n\n<form action=\"https:\/\/cdsatoolkit.thsti.in\/\" id=\"searchform\" method=\"get\" 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