I. EXECUTIVE SUMMARY The MRCT Center Post-trial Responsibilities: Continued Access to an Investigational Medicine Framework outlines a case-based, principled, stakeholder approach to evaluate and guide ethical responsibilities to provide continued access to an investigational medicine at the conclusion of a patient’s participation in a clinical trial. The Post-trial Responsibilities (PTR) Framework includes this Guidance Document as well as the accompanying Toolkit. A 41-member international multi-stakeholder Workgroup convened by the Multi-Regional Clinical Trials Center of Brigham and Women’s Hospital and Harvard University (...) (MRCT Center) developed this Guidance and Toolkit. Project Motivation A number of international organizations have discussed the responsibilities stakeholders have to provide continued access to investigational medicines. The World Medical Association, for example, addressed post-trial access to medicines in Paragraph 34 of the Declaration of Helsinki (WMA, 2013): “In 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.” This paragraph and other international guidance documents converge on several consensus points: • Post-trial access (hereafter referred to as “continued access” in this Framework [for terminology clarification – see definitions]) is the responsibility of sponsors, researchers, and host country governments; • The plan for continued access should be determined before the trial begins, and before any individual gives their informed consent; • The protocol should delineate continued access plans; and • The plan should be transparent to potential participants and explained during the informed consent process. -/- However, there is no guidance on how to fulfill these responsibilities (i.e., linking specific responsibilities with specific stakeholders, conditions, and duration). To fill this gap, the MRCT Center convened a working group in September of 2014 to develop a framework to guide stakeholders with identified responsibilities. This resultant Framework sets forth applicable principles, approaches, recommendations and ethical rationales for PTR regarding continued access to investigational medicines for research participants. (shrink)

The royalist nationalist propaganda writings of King Vajiravudh Rama VI—acclaimed author of the infamous Jews of the Orient, published originally in Thai since 1914—represent some of the finest examples of Anti-Chinese propaganda penned by major nationalist leaders of Thailand in the 20th century. Vajiravudh was a prolific author who produced more than a thousand fictional and non-fictional pieces within his lifetime literary oeuvre. A significant portion of these works was intended as political propaganda, many of which could be justifiably categorized (...) as anti-Chinese pieces. As much of Vajiravudh’s writings also serve as the core texts in much of Thailand’s nationalist propaganda campaigns through much of the early-20th century, it has also come to define the problematic relationship between the Thai conservative ruling class and their ethnic Chinese financial patrons. This makes for very complex national emotions—despise of ethnic Chinese capitalists while venerating royalist conservative political leaders, most of whom, in fact, are of Chinese descent. This also unavoidably bleeds into the realm of everyday social values and relations between ethnic Chinese and non-Chinese commoners in Thai society, their own interpretation of nationalist propaganda, and their own adapted emotions toward each other. This article provides a textual and historical analysis of such writings. (shrink)

The royalist nationalist propaganda writings of King Vajiravudh Rama VI—acclaimed author of the infamous Jews of the Orient, published originally in Thai since 1914—represent some of the finest examples of Anti-Chinese propaganda penned by major nationalist leaders of Thailand in the 20th century. Vajiravudh was a prolific author who produced more than a thousand fictional and non-fictional pieces within his lifetime literary oeuvre. A significant portion of these works was intended as political propaganda, many of which could be justifiably categorized (...) as anti-Chinese pieces. As much of Vajiravudh’s writings also serve as the core texts in much of Thailand’s nationalist propaganda campaigns through much of the early-20th century, it has also come to define the problematic relationship between the Thai conservative ruling class and their ethnic Chinese financial patrons. This makes for very complex national emotions—despise of ethnic Chinese capitalists while venerating royalist conservative political leaders, most of whom, in fact, are of Chinese descent. This also unavoidably bleeds into the realm of everyday social values and relations between ethnic Chinese and non-Chinese commoners in Thai society, their own interpretation of nationalist propaganda, and their own adapted emotions toward each other. This article provides a textual and historical analysis of such writings. (shrink)

The royalist nationalist propaganda writings of King Vajiravudh Rama VI—acclaimed author of the infamous Jews of the Orient, published originally in Thai since 1914—represent some of the finest examples of Anti-Chinese propaganda penned by major nationalist leaders of Thailand in the 20th century. Vajiravudh was a prolific author who produced more than a thousand fictional and non-fictional pieces within his lifetime literary oeuvre. A significant portion of these works was intended as political propaganda, many of which could be justifiably categorized (...) as anti-Chinese pieces. As much of Vajiravudh’s writings also serve as the core texts in much of Thailand’s nationalist propaganda campaigns through much of the early-20th century, it has also come to define the problematic relationship between the Thai conservative ruling class and their ethnic Chinese financial patrons. This makes for very complex national emotions—despise of ethnic Chinese capitalists while venerating royalist conservative political leaders, most of whom, in fact, are of Chinese descent. This also unavoidably bleeds into the realm of everyday social values and relations between ethnic Chinese and non-Chinese commoners in Thai society, their own interpretation of nationalist propaganda, and their own adapted emotions toward each other. This article provides a textual and historical analysis of such writings. (shrink)

The royalist nationalist propaganda writings of King Vajiravudh Rama VI—acclaimed author of the infamous Jews of the Orient, published originally in Thai since 1914—represent some of the finest examples of Anti-Chinese propaganda penned by major nationalist leaders of Thailand in the 20th century. Vajiravudh was a prolific author who produced more than a thousand fictional and non-fictional pieces within his lifetime literary oeuvre. A significant portion of these works was intended as political propaganda, many of which could be justifiably categorized (...) as anti-Chinese pieces. As much of Vajiravudh’s writings also serve as the core texts in much of Thailand’s nationalist propaganda campaigns through much of the early-20th century, it has also come to define the problematic relationship between the Thai conservative ruling class and their ethnic Chinese financial patrons. This makes for very complex national emotions—despise of ethnic Chinese capitalists while venerating royalist conservative political leaders, most of whom, in fact, are of Chinese descent. This also unavoidably bleeds into the realm of everyday social values and relations between ethnic Chinese and non-Chinese commoners in Thai society, their own interpretation of nationalist propaganda, and their own adapted emotions toward each other. This article provides a textual and historical analysis of such writings. (shrink)