Integrating Clinical Research Into Epidemic Response

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Small Clinical Trials

Author : Institute of Medicine
Publisher : National Academies Press
ISBN 13 : 0309171148
Total Pages : 221 pages
Book Rating : 4.3/5 (91 download)

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Book Synopsis Small Clinical Trials by : Institute of Medicine

Download or read book Small Clinical Trials written by Institute of Medicine and published by National Academies Press. This book was released on 2001-01-01 with total page 221 pages. Available in PDF, EPUB and Kindle. Book excerpt: Clinical trials are used to elucidate the most appropriate preventive, diagnostic, or treatment options for individuals with a given medical condition. Perhaps the most essential feature of a clinical trial is that it aims to use results based on a limited sample of research participants to see if the intervention is safe and effective or if it is comparable to a comparison treatment. Sample size is a crucial component of any clinical trial. A trial with a small number of research participants is more prone to variability and carries a considerable risk of failing to demonstrate the effectiveness of a given intervention when one really is present. This may occur in phase I (safety and pharmacologic profiles), II (pilot efficacy evaluation), and III (extensive assessment of safety and efficacy) trials. Although phase I and II studies may have smaller sample sizes, they usually have adequate statistical power, which is the committee's definition of a "large" trial. Sometimes a trial with eight participants may have adequate statistical power, statistical power being the probability of rejecting the null hypothesis when the hypothesis is false. Small Clinical Trials assesses the current methodologies and the appropriate situations for the conduct of clinical trials with small sample sizes. This report assesses the published literature on various strategies such as (1) meta-analysis to combine disparate information from several studies including Bayesian techniques as in the confidence profile method and (2) other alternatives such as assessing therapeutic results in a single treated population (e.g., astronauts) by sequentially measuring whether the intervention is falling above or below a preestablished probability outcome range and meeting predesigned specifications as opposed to incremental improvement.

Sharing Clinical Trial Data

Author : Institute of Medicine
Publisher : National Academies Press
ISBN 13 : 0309316324
Total Pages : 236 pages
Book Rating : 4.3/5 (93 download)

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Book Synopsis Sharing Clinical Trial Data by : Institute of Medicine

Download or read book Sharing Clinical Trial Data written by Institute of Medicine and published by National Academies Press. This book was released on 2015-04-20 with total page 236 pages. Available in PDF, EPUB and Kindle. Book excerpt: Data sharing can accelerate new discoveries by avoiding duplicative trials, stimulating new ideas for research, and enabling the maximal scientific knowledge and benefits to be gained from the efforts of clinical trial participants and investigators. At the same time, sharing clinical trial data presents risks, burdens, and challenges. These include the need to protect the privacy and honor the consent of clinical trial participants; safeguard the legitimate economic interests of sponsors; and guard against invalid secondary analyses, which could undermine trust in clinical trials or otherwise harm public health. Sharing Clinical Trial Data presents activities and strategies for the responsible sharing of clinical trial data. With the goal of increasing scientific knowledge to lead to better therapies for patients, this book identifies guiding principles and makes recommendations to maximize the benefits and minimize risks. This report offers guidance on the types of clinical trial data available at different points in the process, the points in the process at which each type of data should be shared, methods for sharing data, what groups should have access to data, and future knowledge and infrastructure needs. Responsible sharing of clinical trial data will allow other investigators to replicate published findings and carry out additional analyses, strengthen the evidence base for regulatory and clinical decisions, and increase the scientific knowledge gained from investments by the funders of clinical trials. The recommendations of Sharing Clinical Trial Data will be useful both now and well into the future as improved sharing of data leads to a stronger evidence base for treatment. This book will be of interest to stakeholders across the spectrum of research-from funders, to researchers, to journals, to physicians, and ultimately, to patients.

Integrating Clinical Research into Epidemic Response

Author : National Academies of Sciences, Engineering, and Medicine
Publisher : National Academies Press
ISBN 13 : 0309457793
Total Pages : 343 pages
Book Rating : 4.3/5 (94 download)

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Book Synopsis Integrating Clinical Research into Epidemic Response by : National Academies of Sciences, Engineering, and Medicine

Download or read book Integrating Clinical Research into Epidemic Response written by National Academies of Sciences, Engineering, and Medicine and published by National Academies Press. This book was released on 2017-06-26 with total page 343 pages. Available in PDF, EPUB and Kindle. Book excerpt: The 2014â€"2015 Ebola epidemic in western Africa was the longest and most deadly Ebola epidemic in history, resulting in 28,616 cases and 11,310 deaths in Guinea, Liberia, and Sierra Leone. The Ebola virus has been known since 1976, when two separate outbreaks were identified in the Democratic Republic of Congo (then Zaire) and South Sudan (then Sudan). However, because all Ebola outbreaks prior to that in West Africa in 2014â€"2015 were relatively isolated and of short duration, little was known about how to best manage patients to improve survival, and there were no approved therapeutics or vaccines. When the World Heath Organization declared the 2014-2015 epidemic a public health emergency of international concern in August 2014, several teams began conducting formal clinical trials in the Ebola affected countries during the outbreak. Integrating Clinical Research into Epidemic Response: The Ebola Experience assesses the value of the clinical trials held during the 2014â€"2015 epidemic and makes recommendations about how the conduct of trials could be improved in the context of a future international emerging or re-emerging infectious disease events.

The Ebola Epidemic in West Africa

Author : National Academies of Sciences, Engineering, and Medicine
Publisher : National Academies Press
ISBN 13 : 0309450063
Total Pages : 137 pages
Book Rating : 4.3/5 (94 download)

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Book Synopsis The Ebola Epidemic in West Africa by : National Academies of Sciences, Engineering, and Medicine

Download or read book The Ebola Epidemic in West Africa written by National Academies of Sciences, Engineering, and Medicine and published by National Academies Press. This book was released on 2016-12-30 with total page 137 pages. Available in PDF, EPUB and Kindle. Book excerpt: The most recent Ebola epidemic that began in late 2013 alerted the entire world to the gaps in infectious disease emergency preparedness and response. The regional outbreak that progressed to a significant public health emergency of international concern (PHEIC) in a matter of months killed 11,310 and infected more than 28,616. While this outbreak bears some unique distinctions to past outbreaks, many characteristics remain the same and contributed to tragic loss of human life and unnecessary expenditure of capital: insufficient knowledge of the disease, its reservoirs, and its transmission; delayed prevention efforts and treatment; poor control of the disease in hospital settings; and inadequate community and international responses. Recognizing the opportunity to learn from the countless lessons of this epidemic, the National Academies of Sciences, Engineering, and Medicine convened a workshop in March 2015 to discuss the challenges to successful outbreak responses at the scientific, clinical, and global health levels. Workshop participants explored the epidemic from multiple perspectives, identified important questions about Ebola that remained unanswered, and sought to apply this understanding to the broad challenges posed by Ebola and other emerging pathogens, to prevent the international community from being taken by surprise once again in the face of these threats. This publication summarizes the presentations and discussions from the workshop.

Global Health Risk Framework

Author : National Academies of Sciences, Engineering, and Medicine
Publisher : National Academies Press
ISBN 13 : 0309381029
Total Pages : 141 pages
Book Rating : 4.3/5 (93 download)

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Book Synopsis Global Health Risk Framework by : National Academies of Sciences, Engineering, and Medicine

Download or read book Global Health Risk Framework written by National Academies of Sciences, Engineering, and Medicine and published by National Academies Press. This book was released on 2016-05-06 with total page 141 pages. Available in PDF, EPUB and Kindle. Book excerpt: Since the 2014 Ebola outbreak many public- and private-sector leaders have seen a need for improved management of global public health emergencies. The effects of the Ebola epidemic go well beyond the three hardest-hit countries and beyond the health sector. Education, child protection, commerce, transportation, and human rights have all suffered. The consequences and lethality of Ebola have increased interest in coordinated global response to infectious threats, many of which could disrupt global health and commerce far more than the recent outbreak. In order to explore the potential for improving international management and response to outbreaks the National Academy of Medicine agreed to manage an international, independent, evidence-based, authoritative, multistakeholder expert commission. As part of this effort, the Institute of Medicine convened four workshops in summer of 2015 to inform the commission report. The presentations and discussions from the Workshop on Research and Development of Medical Products are summarized in this report.

Pandemic Influenza Preparedness and Response

Author : World Health Organization
Publisher : World Health Organization
ISBN 13 : 9241547685
Total Pages : 62 pages
Book Rating : 4.2/5 (415 download)

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Book Synopsis Pandemic Influenza Preparedness and Response by : World Health Organization

Download or read book Pandemic Influenza Preparedness and Response written by World Health Organization and published by World Health Organization. This book was released on 2009 with total page 62 pages. Available in PDF, EPUB and Kindle. Book excerpt: This guidance is an update of WHO global influenza preparedness plan: the role of WHO and recommendations for national measures before and during pandemics, published March 2005 (WHO/CDS/CSR/GIP/2005.5).

Learning from SARS

Author : Institute of Medicine
Publisher : National Academies Press
ISBN 13 : 0309182158
Total Pages : 376 pages
Book Rating : 4.3/5 (91 download)

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Book Synopsis Learning from SARS by : Institute of Medicine

Download or read book Learning from SARS written by Institute of Medicine and published by National Academies Press. This book was released on 2004-04-26 with total page 376 pages. Available in PDF, EPUB and Kindle. Book excerpt: The emergence of severe acute respiratory syndrome (SARS) in late 2002 and 2003 challenged the global public health community to confront a novel epidemic that spread rapidly from its origins in southern China until it had reached more than 25 other countries within a matter of months. In addition to the number of patients infected with the SARS virus, the disease had profound economic and political repercussions in many of the affected regions. Recent reports of isolated new SARS cases and a fear that the disease could reemerge and spread have put public health officials on high alert for any indications of possible new outbreaks. This report examines the response to SARS by public health systems in individual countries, the biology of the SARS coronavirus and related coronaviruses in animals, the economic and political fallout of the SARS epidemic, quarantine law and other public health measures that apply to combating infectious diseases, and the role of international organizations and scientific cooperation in halting the spread of SARS. The report provides an illuminating survey of findings from the epidemic, along with an assessment of what might be needed in order to contain any future outbreaks of SARS or other emerging infections.

Integrating Clinical Research into Epidemic Response

Author : National Academies of Sciences, Engineering, and Medicine
Publisher : National Academies Press
ISBN 13 : 0309457769
Total Pages : 343 pages
Book Rating : 4.3/5 (94 download)

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Book Synopsis Integrating Clinical Research into Epidemic Response by : National Academies of Sciences, Engineering, and Medicine

Download or read book Integrating Clinical Research into Epidemic Response written by National Academies of Sciences, Engineering, and Medicine and published by National Academies Press. This book was released on 2017-07-26 with total page 343 pages. Available in PDF, EPUB and Kindle. Book excerpt: The 2014â€"2015 Ebola epidemic in western Africa was the longest and most deadly Ebola epidemic in history, resulting in 28,616 cases and 11,310 deaths in Guinea, Liberia, and Sierra Leone. The Ebola virus has been known since 1976, when two separate outbreaks were identified in the Democratic Republic of Congo (then Zaire) and South Sudan (then Sudan). However, because all Ebola outbreaks prior to that in West Africa in 2014â€"2015 were relatively isolated and of short duration, little was known about how to best manage patients to improve survival, and there were no approved therapeutics or vaccines. When the World Heath Organization declared the 2014-2015 epidemic a public health emergency of international concern in August 2014, several teams began conducting formal clinical trials in the Ebola affected countries during the outbreak. Integrating Clinical Research into Epidemic Response: The Ebola Experience assesses the value of the clinical trials held during the 2014â€"2015 epidemic and makes recommendations about how the conduct of trials could be improved in the context of a future international emerging or re-emerging infectious disease events.

Evidence-Based Practice for Public Health Emergency Preparedness and Response

Author : National Academies of Sciences, Engineering, and Medicine
Publisher : National Academies Press
ISBN 13 : 0309670381
Total Pages : 501 pages
Book Rating : 4.3/5 (96 download)

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Book Synopsis Evidence-Based Practice for Public Health Emergency Preparedness and Response by : National Academies of Sciences, Engineering, and Medicine

Download or read book Evidence-Based Practice for Public Health Emergency Preparedness and Response written by National Academies of Sciences, Engineering, and Medicine and published by National Academies Press. This book was released on 2020-11-28 with total page 501 pages. Available in PDF, EPUB and Kindle. Book excerpt: When communities face complex public health emergencies, state local, tribal, and territorial public health agencies must make difficult decisions regarding how to effectively respond. The public health emergency preparedness and response (PHEPR) system, with its multifaceted mission to prevent, protect against, quickly respond to, and recover from public health emergencies, is inherently complex and encompasses policies, organizations, and programs. Since the events of September 11, 2001, the United States has invested billions of dollars and immeasurable amounts of human capital to develop and enhance public health emergency preparedness and infrastructure to respond to a wide range of public health threats, including infectious diseases, natural disasters, and chemical, biological, radiological, and nuclear events. Despite the investments in research and the growing body of empirical literature on a range of preparedness and response capabilities and functions, there has been no national-level, comprehensive review and grading of evidence for public health emergency preparedness and response practices comparable to those utilized in medicine and other public health fields. Evidence-Based Practice for Public Health Emergency Preparedness and Response reviews the state of the evidence on PHEPR practices and the improvements necessary to move the field forward and to strengthen the PHEPR system. This publication evaluates PHEPR evidence to understand the balance of benefits and harms of PHEPR practices, with a focus on four main areas of PHEPR: engagement with and training of community-based partners to improve the outcomes of at-risk populations after public health emergencies; activation of a public health emergency operations center; communication of public health alerts and guidance to technical audiences during a public health emergency; and implementation of quarantine to reduce the spread of contagious illness.

Psychiatry of Pandemics

Author : Damir Huremović
Publisher : Springer
ISBN 13 : 3030153460
Total Pages : 188 pages
Book Rating : 4.0/5 (31 download)

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Book Synopsis Psychiatry of Pandemics by : Damir Huremović

Download or read book Psychiatry of Pandemics written by Damir Huremović and published by Springer. This book was released on 2019-05-15 with total page 188 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book focuses on how to formulate a mental health response with respect to the unique elements of pandemic outbreaks. Unlike other disaster psychiatry books that isolate aspects of an emergency, this book unifies the clinical aspects of disaster and psychosomatic psychiatry with infectious disease responses at the various levels, making it an excellent resource for tackling each stage of a crisis quickly and thoroughly. The book begins by contextualizing the issues with a historical and infectious disease overview of pandemics ranging from the Spanish flu of 1918, the HIV epidemic, Ebola, Zika, and many other outbreaks. The text acknowledges the new infectious disease challenges presented by climate changes and considers how to implement systems to prepare for these issues from an infection and social psyche perspective. The text then delves into the mental health aspects of these crises, including community and cultural responses, emotional epidemiology, and mental health concerns in the aftermath of a disaster. Finally, the text considers medical responses to situation-specific trauma, including quarantine and isolation-associated trauma, the mental health aspects of immunization and vaccination, survivor mental health, and support for healthcare personnel, thereby providing guidance for some of the most alarming trends facing the medical community. Written by experts in the field, Psychiatry of Pandemics is an excellent resource for infectious disease specialists, psychiatrists, psychologists, immunologists, hospitalists, public health officials, nurses, and medical professionals who may work patients in an infectious disease outbreak.

The Prevention and Treatment of Missing Data in Clinical Trials

Author : National Research Council
Publisher : National Academies Press
ISBN 13 : 030918651X
Total Pages : 163 pages
Book Rating : 4.3/5 (91 download)

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Book Synopsis The Prevention and Treatment of Missing Data in Clinical Trials by : National Research Council

Download or read book The Prevention and Treatment of Missing Data in Clinical Trials written by National Research Council and published by National Academies Press. This book was released on 2010-12-21 with total page 163 pages. Available in PDF, EPUB and Kindle. Book excerpt: Randomized clinical trials are the primary tool for evaluating new medical interventions. Randomization provides for a fair comparison between treatment and control groups, balancing out, on average, distributions of known and unknown factors among the participants. Unfortunately, these studies often lack a substantial percentage of data. This missing data reduces the benefit provided by the randomization and introduces potential biases in the comparison of the treatment groups. Missing data can arise for a variety of reasons, including the inability or unwillingness of participants to meet appointments for evaluation. And in some studies, some or all of data collection ceases when participants discontinue study treatment. Existing guidelines for the design and conduct of clinical trials, and the analysis of the resulting data, provide only limited advice on how to handle missing data. Thus, approaches to the analysis of data with an appreciable amount of missing values tend to be ad hoc and variable. The Prevention and Treatment of Missing Data in Clinical Trials concludes that a more principled approach to design and analysis in the presence of missing data is both needed and possible. Such an approach needs to focus on two critical elements: (1) careful design and conduct to limit the amount and impact of missing data and (2) analysis that makes full use of information on all randomized participants and is based on careful attention to the assumptions about the nature of the missing data underlying estimates of treatment effects. In addition to the highest priority recommendations, the book offers more detailed recommendations on the conduct of clinical trials and techniques for analysis of trial data.

The Social Impact of AIDS in the United States

Author : National Research Council
Publisher : National Academies Press
ISBN 13 : 0309046289
Total Pages : 337 pages
Book Rating : 4.3/5 (9 download)

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Book Synopsis The Social Impact of AIDS in the United States by : National Research Council

Download or read book The Social Impact of AIDS in the United States written by National Research Council and published by National Academies Press. This book was released on 1993-02-01 with total page 337 pages. Available in PDF, EPUB and Kindle. Book excerpt: Europe's "Black Death" contributed to the rise of nation states, mercantile economies, and even the Reformation. Will the AIDS epidemic have similar dramatic effects on the social and political landscape of the twenty-first century? This readable volume looks at the impact of AIDS since its emergence and suggests its effects in the next decade, when a million or more Americans will likely die of the disease. The Social Impact of AIDS in the United States addresses some of the most sensitive and controversial issues in the public debate over AIDS. This landmark book explores how AIDS has affected fundamental policies and practices in our major institutions, examining: How America's major religious organizations have dealt with sometimes conflicting values: the imperative of care for the sick versus traditional views of homosexuality and drug use. Hotly debated public health measures, such as HIV antibody testing and screening, tracing of sexual contacts, and quarantine. The potential risk of HIV infection to and from health care workers. How AIDS activists have brought about major change in the way new drugs are brought to the marketplace. The impact of AIDS on community-based organizations, from volunteers caring for individuals to the highly political ACT-UP organization. Coping with HIV infection in prisons. Two case studies shed light on HIV and the family relationship. One reports on some efforts to gain legal recognition for nonmarital relationships, and the other examines foster care programs for newborns with the HIV virus. A case study of New York City details how selected institutions interact to give what may be a picture of AIDS in the future. This clear and comprehensive presentation will be of interest to anyone concerned about AIDS and its impact on the country: health professionals, sociologists, psychologists, advocates for at-risk populations, and interested individuals.

International Ethical Guidelines for Health-Related Research Involving Humans

Author : Council for International Organizations of Medical Sciences (CIOMS)
Publisher : World Health Organization
ISBN 13 : 9789290360889
Total Pages : 0 pages
Book Rating : 4.3/5 (68 download)

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Book Synopsis International Ethical Guidelines for Health-Related Research Involving Humans by : Council for International Organizations of Medical Sciences (CIOMS)

Download or read book International Ethical Guidelines for Health-Related Research Involving Humans written by Council for International Organizations of Medical Sciences (CIOMS) and published by World Health Organization. This book was released on 2017-01-31 with total page 0 pages. Available in PDF, EPUB and Kindle. Book excerpt: "In the new 2016 version of the ethical guidelines, CIOMS provides answers to a number of pressing issues in research ethics. The Council does so by stressing the need for research having scientific and social value, by providing special guidelines for health-related research in low-resource settings, by detailing the provisions for involving vulnerable groups in research and for describing under what conditions biological samples and health-related data can be used for research."--Page 4 de la couverture.

Building Communication Capacity to Counter Infectious Disease Threats

Author : National Academies of Sciences, Engineering, and Medicine
Publisher : National Academies Press
ISBN 13 : 0309457688
Total Pages : 139 pages
Book Rating : 4.3/5 (94 download)

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Book Synopsis Building Communication Capacity to Counter Infectious Disease Threats by : National Academies of Sciences, Engineering, and Medicine

Download or read book Building Communication Capacity to Counter Infectious Disease Threats written by National Academies of Sciences, Engineering, and Medicine and published by National Academies Press. This book was released on 2017-07-14 with total page 139 pages. Available in PDF, EPUB and Kindle. Book excerpt: Building communication capacity is a critical piece of preparing for, detecting, and responding to infectious disease threats. The International Health Regulations (IHR) establish risk communicationâ€"the real-time exchange of information, advice, and opinions between experts or officials and people who face a threat to their survival, health, and economic or social well-beingâ€"as a core capacity that World Health Organization member states must fulfill to strengthen the fight against these threats. Despite global recognition of the importance of complying with IHR, 67 percent of signatory countries report themselves as not compliant. By investing in communication capacity, public health and government officials and civil society organizations facing health crises would be prepared to provide advice, information, and reassurance to the public as well as to rapidly develop messages and community engagement activities that are coordinated and take into account social and behavioral dynamics among all sectors. To learn about current national and international efforts to develop the capacity to communicate effectively during times of infectious disease outbreaks, and to explore gaps in the research agenda that may help address communication needs to advance the field, the Forum on Microbial Threats of the National Academies of Sciences, Engineering, and Medicine convened a 1.5 day workshop on December 13 and 14, 2016, in Washington, DC. Participants reviewed progress and needs in strengthening communication capacity for dealing with infectious disease threats for both outbreaks and routine challenges in the United States and abroad. This publication summarizes the presentations and discussions from the workshop.

Global Health Risk Framework

Author : National Academies of Sciences, Engineering, and Medicine
Publisher : National Academies Press
ISBN 13 : 0309381045
Total Pages : 201 pages
Book Rating : 4.3/5 (93 download)

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Book Synopsis Global Health Risk Framework by : National Academies of Sciences, Engineering, and Medicine

Download or read book Global Health Risk Framework written by National Academies of Sciences, Engineering, and Medicine and published by National Academies Press. This book was released on 2016-06-11 with total page 201 pages. Available in PDF, EPUB and Kindle. Book excerpt: Since the 2014 Ebola outbreak many public- and private-sector leaders have seen a need for improved management of global public health emergencies. The effects of the Ebola epidemic go well beyond the three hardest-hit countries and beyond the health sector. Education, child protection, commerce, transportation, and human rights have all suffered. The consequences and lethality of Ebola have increased interest in coordinated global response to infectious threats, many of which could disrupt global health and commerce far more than the recent outbreak. In order to explore the potential for improving international management and response to outbreaks the National Academy of Medicine agreed to manage an international, independent, evidence-based, authoritative, multistakeholder expert commission. As part of this effort, the Institute of Medicine convened four workshops in summer of 2015 to inform the commission report. The presentations and discussions from the Governance for Global Health Workshop are summarized in this report.

Ebola

Author : Paul Richards
Publisher : Zed Books Ltd.
ISBN 13 : 1783608617
Total Pages : 208 pages
Book Rating : 4.7/5 (836 download)

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Book Synopsis Ebola by : Paul Richards

Download or read book Ebola written by Paul Richards and published by Zed Books Ltd.. This book was released on 2016-09-15 with total page 208 pages. Available in PDF, EPUB and Kindle. Book excerpt: Shortlisted for the Fage and Oliver Prize 2018 From December 2013, the largest Ebola outbreak in history swept across West Africa, claiming thousands of lives in Liberia, Sierra Leone and Guinea. By the middle of 2014, the international community was gripped by hysteria. Experts grimly predicted that millions would be infected within months, and a huge international control effort was mounted to contain the virus. Yet paradoxically, by this point the disease was already going into decline in Africa itself. So why did outside observers get it so wrong? Paul Richards draws on his extensive first-hand experience in Sierra Leone to argue that the international community’s panicky response failed to take account of local expertise and common sense. Crucially, Richards shows that the humanitarian response to the disease was most effective in those areas where it supported these initiatives and that it hampered recovery when it ignored or disregarded local knowledge.

The CAPRISA Clinical Trials: HIV Treatment and Prevention

Author : Quarraisha Abdool Karim
Publisher : Springer
ISBN 13 : 9783319837567
Total Pages : 243 pages
Book Rating : 4.8/5 (375 download)

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Book Synopsis The CAPRISA Clinical Trials: HIV Treatment and Prevention by : Quarraisha Abdool Karim

Download or read book The CAPRISA Clinical Trials: HIV Treatment and Prevention written by Quarraisha Abdool Karim and published by Springer. This book was released on 2018-04-29 with total page 243 pages. Available in PDF, EPUB and Kindle. Book excerpt: Since its inception 14 years ago, CAPRISA has conducted numerous clinical studies that have influenced international TB-HIV treatment guidelines as well as HIV prevention through innovations in the microbicide and vaccine fields. This book provides a historical account of how each of CAPRISA’s high impact studies was created, developed, implemented, analysed and communicated. In doing so, the reader is taken on a journey that provides glimpses into the genesis of research ideas and how this ultimately leads to a range of HIV prevention and treatment studies that have impacted the global response to the HIV and TB epidemics. Comprised of 5 sections, the book details the following: HIV epidemic in South Africa and the establishment of a research centre to undertake clinical, epidemiological and laboratory research on HIV. CAPRISA’s clinical trials on HIV and HSV-2 prevention. These studies investigated the impact of tenofovir gel as topical antiretroviral pre-exposure prophylaxis (PrEP), implementation of topical PrEP through family planning clinics, conditional cash incentives for HIV prevention, HIV vaccines, and passive immunisation with broadly neutralising antibodies. CAPRISA’s research on the treatment of HIV and TB co-infection. A review of the major scientific findings from the CAPRISA studies on acute infection and genital mucosal immunology. Essential support activities for the conduct of clinical trials, including research laboratories and pharmacies, as well as establishing effective communication and sustainable structures for community engagement to maintain effective and respectful partnerships with participating communities. The book concludes with a chapter about the challenges facing future HIV prevention and treatment trials. The CAPRISA Clinical Trials: HIV Treatment and Prevention is a resource for undergraduate and postgraduate students, health care providers, doctors, decision-makers and researchers who are seeking guidance and insights on clinical trials – their creation, conduct and impact.