REPORT OF THE 2018 ONE DAY FREE WORKSHOP ON CLINICAL RESEARCH CAPACITY BUILDING FOR CLINICAL RESEARCH IN NIGERIAby Glory Oluwagbenga Ogunfowokan - Regional Faculty Lead, morenike Ukpong, AUGUSTINE ONYEAGHALA - Senior Contributor, ogundokun Olusegun - Senior Contributor, Regional Faculty Committee Member, Ekezie Ralueke Oluchukwu
This report details the workshop held on 7th July 2018 at the Nigerian Airforce Conference Centre, Abuja.
This Guide to Efficient Trial Management, published by the Trial Manager's Network (UK) and available freely online, is a must for all trial managers or coordinators. This link is for the 6th Edition (2018)
Pragmatism in practice: lessons learned during screening and enrollment for a randomised controlled trial in rural northern Ethiopiaby Meseret Molla, Henok Negussie, Moses Ngari, Esther Kivaya, Patricia Njuguna, Fikre Enqueselassie, James A. Berkley, Gail Davey
We use the example of the Gojjam Lymphoedema Best Practice Trial (GoLBeT), a pragmatic trial in a remote rural setting in northern Ethiopia, to extract lessons relevant to other investigators balancing the demands of practicality and community acceptability with internal and external validity in clinical trials.
The Nigerian Global Health Trial Conference 2018 took place on the 30th and 31st of January 2018 the Sickle Cell Centre, Idi-Araba, Lagos. The full report here is shared to allow others to experience and learn from the event.
We have to learn as much as we can about the benefits, risks, costs, and appropriate role of disclosing participant-level data, in service to the ultimate goal of honoring each trial volunteer's altruism.
a milestone for data transparency in clinical research is within reach- it is hoped this is not unnecessarily delayed.
Jimmy Whitworth calls for a more sustainable and palatable pathway be will to build consensus and to create a broad coalition.
Mark Walport and Paul Brest argues that we need to ensure that research outputs are used to maximise knowledge and potential health benefits
In this paper, Andrew Vickers argues that attitudes towards data sharing in the clinical trial community need to rethought, drastically
This study looks at the challneges of data sharing globally.
Publishing the results of all clinical trials, whoever funds them, is required for ethical, scientific, economic, and societal reasons
Rapid release of prepublication data has served the field of genomics well. Attendees at a workshop in Toronto recommend extending the practice to other biological data sets.
Sharing data is not only about the technical dimension such as data management, repositories and libraries; developing countries are concerned about factors that impede data sharing, in particular, fairness
Lack of proportionality. Seven specifications of public interest that override post-approval commercial interests on limited access to clinical databy Strech D, Littmann J
Comparing potential commercial interests with seven specifications of relevant public interest reveals the lack of proportionality inherent in the current practices of EMA and NICE.
John A. Spertus suggests that there needs to be some consideration about the practicalities of data sharing- in how it is shared, investment, and ensuring that data are appropriately analyzed
This article argues that scientists need to feel greater urgency to share their findings quickly, and they need additional avenues to facilitate this process.
Clinical trial transparency and orphan drug development: recent trends in data sharing by the pharmaceutical industryby So D, Joly Y, Knoppers BM
This paper summarises major developments in clinical trial transparency between January and June 2013 and analyses the composition of datasets released by GlaxoSmithKline.
This article looks at the benefits of data sharing, and argues for increasing the accessibility of data
This article details the procedures and requirements for researchers in sharing data from clinical trials.