BMC Research Notes
(Accessed 26 Jan 2019)
Health professionals’ willingness to pay and associated factors for human papilloma virus vaccination to prevent cervical cancer at College of Medicine and Health Sciences University of Gondar, Northwest Ethiopia
Preferences of health professionals’ for human papilloma virus vaccines was measured by monetary value through willingness to pay (WTP) approach that could help policy makers set priorities among alternative c…
Authors: Abebe Ayinalem Tarekegn and Ayenew Engida Yismaw
Citation: BMC Research Notes 2019 12:58
Published on: 24 January 2019
Volume 16 Issue 1, February 2019
Strategic inclusion of regions in multiregional clinical trials
Seung Yeon Song, Deborah Chee, EunYoung Kim
First Published November 16, 2018; pp. 98–105
With the recent publication of the International Conference on Harmonisation E17 guideline and major reforms in China underway, the platform for clinical trial conduct is expected to change. This study aims to assess the strategic inclusion of regions in clinical trials and its change in trends over the past decade.
The ClinicalTrials.gov registry was searched for clinical trials registered by the top 10 pharmaceutical companies between 1 January 2008 and 31 December 2017. Extracted data included phase, disease type, intervention, study start year, and region. Trial type was classified as either a local study or a multiregional clinical trial as per the International Conference on Harmonisation E17 guideline.
Of 2488 phase I, 1855 phase II, and 1999 phase III trials included, the majority of phase I trials were local studies (76.8%), while the majority of phase II (66.0%) and phase III (72.2%) trials were multiregional clinical trials. The proportion of multiregional clinical trials showed an increasing trend for all phases (p < 0.01). Although North America and Europe remained the main locations, increasing trends of inclusion of other regions, such as East Asia, were noted.
Globalization of drug development is evident with the increasing trend of multiregional clinical trial. Regulatory authorities as well as the pharmaceutical industry should prepare for the evolving setting of clinical research and problems that can arise from these changes.
Ethics & Human Research
Volume 41, Issue 1 January-February 2019
New Challenges and Unresolved Issues
The inaugural issue of Ethics & Human Research (E&HR) marks an exciting milestone in The Hastings Centers’ 40‐year history of publishing a journal that focuses on the ethical, regulatory, and policy issues related to research with humans. Like its predecessor, IRB: Ethics & Human Research, E&HR will publish conceptual and empirical analyses on a wide range of topics related to the human research enterprise.
The journal’s name change conveys to the global community of authors and readers that E&HR is not solely about issues related to institutional review boards (IRBs) in the United States. The title shift provides an opportunity to identify new ethical, policy, and regulatory challenges that rapid developments in science, medicine, and regulatory frameworks bring to the conduct and oversight of human subjects research in the United States and elsewhere. Along with publishing work that investigates new challenges, E&HR aims not only to draw attention to unresolved issues but also to broaden the scope of issues for investigation and analysis in the field of human research ethics. The pieces in this inaugural issue identify several new challenges and hint at some of the unresolved issues and broader topics that merit further attention.
Health Research Policy and Systems
[Accessed 26 Jan 2019]
What, why and how do health systems learn from one another? Insights from eight low- and middle-income country case studies
All health systems struggle to meet health needs within constrained resources. This is especially true for low-income countries. It is critical that they can learn from wider contexts in order to improve their…
Authors: Sophie Witter, Ian Anderson, Peter Annear, Abiodun Awosusi, Nitin N. Bhandari, Nouria Brikci, Blandine Binachon, Tata Chanturidze, Katherine Gilbert, Charity Jensen, Tomas Lievens, Barbara McPake, Snehashish Raichowdhury and Alex Jones
Citation: Health Research Policy and Systems 2019 17:9
Published on: 21 January 2019
International Journal of Community Medicine and Public Health
Vol 6, No 2 (2019) February 2019
Original Research Articles
Assessment of immunization coverage in district Srinagar of Kashmir
Ambrine Ashraf, Sheema Samreen, S. M. Salim Khan, Inaamul Haq, Mariya Amin