scholarly journals Ethical Challenges and Lessons Learned During the Clinical Development of a Group A Meningococcal Conjugate Vaccine

2015 ◽  
Vol 61 (suppl_5) ◽  
pp. S422-S427 ◽  
Author(s):  
Lionel Martellet ◽  
Samba O. Sow ◽  
Aldiouma Diallo ◽  
Abraham Hodgson ◽  
Beate Kampmann ◽  
...  
2020 ◽  
Vol 30 (Supplement_5) ◽  
Author(s):  
P Schröder-Bäck ◽  
T Schloemer ◽  
K Martakis ◽  
C Brall

Abstract Background The outbreak of SARS in 2002 lead to a public health ethics discourse. The crisis management of that time was ethically analysed and lessons to be learned discussed. Scholarship and WHO, among others, developed an ethics of pandemic preparedness. The current “corona crisis” also faces us with ethical challenges. This presentation is comparing the two crises from an ethical point of view and a focus on Europe. Methods An ethics framework for pandemic preparedness (Schröder et al. 2006 and Schröder-Bäck 2014) is used to make a synopsis of ethical issues. Ethical aspects of 2002 and 2020 that were discussed in the literature and in the media are compared. For 2020, the focus is on interventions in Italy, Germany, Switzerland, and the Netherlands. Results Topics that emerged from the 2002 crisis were, among others, revolving around aspects of stigmatisation and fair distribution of scarce resources (esp. vaccines, antivirals). Currently, most urgent and ethically challenging aspects relate to social distancing vs. autonomy: Isolation and quarantine are handled differently across Europe and the EU. Questions of transferability of such interventions prevail. Contexts vary vertically over time (2002 vs. 2020) and horizontally (e.g. between Italy and Germany at the same time). Furthermore, trust in authorities, media and health information is a key issue. Conclusions Ethical aspects are key for good pandemic preparedness and management. The context of the crises between 2002 and 2020 has slightly changed, also based on “lessons learned” from 2002. This has implications on ethical issues that are being discussed. New lessons will have to be learned from the 2020 crisis. Key messages Pandemic preparedness and outbreak management entail many ethical tensions that need to be addressed. Currently, questions of trust and transferability are key to the crisis management, further ethical issues could still emerge.


2018 ◽  
Vol 8 (5) ◽  
pp. 474-477 ◽  
Author(s):  
Fouad Madhi ◽  
Corinne Levy ◽  
Laurence Morin ◽  
Philippe Minodier ◽  
François Dubos ◽  
...  

AbstractWe describe here changes in the bacterial causes of pleural empyema before and after implementation of the 13-valent pneumococcal conjugate vaccine (PCV13) program in France (2009–2017). For 220 (39.3%) of 560 children, a bacterial cause was found. The frequency of pneumococcal infection decreased during the study from 79.1% in 2009 to 36.4% in 2017 (P < .001). Group A streptococcus is now the leading cause of documented empyema (45.5%).


2018 ◽  
Vol 63 (3) ◽  
pp. 269-279 ◽  
Author(s):  
Lidia C. Serra ◽  
Laura J. York ◽  
Paul Balmer ◽  
Chris Webber

PLoS ONE ◽  
2012 ◽  
Vol 7 (1) ◽  
pp. e29116 ◽  
Author(s):  
Sung Hye Kim ◽  
Lorenzo Pezzoli ◽  
Harouna Yacouba ◽  
Tiekoura Coulibaly ◽  
Mamoudou H. Djingarey ◽  
...  
Keyword(s):  

2019 ◽  
Vol 3 (Supplement_1) ◽  
pp. S199-S199
Author(s):  
George Demiris ◽  
Karen Hirschman

Abstract In order to better support older adults with life-limiting illness and their families, many initiatives utilize information technology and other innovative platforms to increase access to supportive services and bridge geographic distance. Such technologies cover a broad range of systems ranging from smart phone applications to wearables and traditional telehealth platforms. There is a growing evidence base for such interventions but technical, clinical and ethical challenges remain when utilizing technology in the context of hospice and palliative care especially for older adults, including the concerns for caregiver burden, privacy, security, confidentiality, obtrusiveness and accessibility. In this symposium we provide an overview of innovative tools available for interventions in palliative and hospice care designed for patients and/or family caregivers in urban and rural settings. We provide lessons learned from three NIH funded studies testing different technology-based interventions in various settings including home hospice and outpatient palliative care. Discussion will follow focused on the clinical, ethical and practical challenges of innovation and the unique considerations for technology-mediated intervention design in a variety of palliative and hospice care settings. This symposium aims to provide: 1. an overview of existing technology-based interventions for older adults and their families in palliative care and hospice 2. evidence-based recommendations resulting from clinical trials in urban and rural settings for the design and implementation of innovative tools in hospice and palliative care 3. a discussion of challenges and opportunities for the use of technology to support older adults and their families


Cancers ◽  
2019 ◽  
Vol 11 (9) ◽  
pp. 1320 ◽  
Author(s):  
Nazareth ◽  
Jones ◽  
Gabrielli

The poor selectivity of standard cytotoxic chemotherapy regimens causes severe side-effects in patients and reduces the quality of life during treatment. Targeting cancer-specific vulnerabilities can improve response rates, increase overall survival and limit toxic side effects in patients. Oncogene-induced replication stress serves as a tumour specific vulnerability and rationale for the clinical development of inhibitors targeting the DNA damage response (DDR) kinases (CHK1, ATR, ATM and WEE1). CHK1 inhibitors (CHK1i) have served as the pilot compounds in this class and their efficacy in clinical trials as single agents has been disappointing. Initial attempts to combine CHK1i with chemotherapies agents that enhance replication stress (such as gemcitabine) were reported to be excessively toxic. More recently, it has emerged that combining CHK1i with subclinical doses of replication stress inducers is more effective, better tolerated and more compatible with immunotherapies. Here we focus on the lessons learned during the clinical development of CHK1i with the goal of improving the design of future clinical trials utilizing DDR inhibitors to target replication stress in cancer.


2019 ◽  
Vol 41 (1) ◽  
pp. 12-14
Author(s):  
Kristin Post

Abstract In order to collaborate on human subjects research, social scientists require flexible approaches that allow them to adhere to legal and ethical protections specific to their community or profession. Such flexibility is illustrated in the Ebola 100 Project (2018), a “voluntary, collaborative, multi-institutional, and international” anthropological research project that captured lessons learned about organizational responses to the West Africa Ebola outbreak of 2014–2015. The inclusive project comprised almost a dozen investigators from government and non-government organizations from several different countries. A few of the project's United States contributors worked as part of the Translational Research Group, a research facility housed under the Marine Corps culture center. These researchers had access to potential participants in the military and experience conducting qualitative research in compliance with Department of Defense human subjects protection regulations. One outcome of the inclusive and flexible design of the Ebola 100 Project is that it allows for participation from relatively under-represented populations in traditional anthropological research, such as United States military personnel. Upon completion of the Ebola 100 Project, researchers interested in analyzing the experiences and stories of individuals who responded to a global health emergency can access more than 100 interviews.


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