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Written in concise language simple enough to be accessible to those new in the field, the dozens of real-life stories and detailed case studies at the end of each chapter make the book an invaluable resource for the more experienced, highlighting what can go wrong in a clinical study: A study of prostate cancer in the UK - An investigator brochure was not provided.
The company argued that a brochure was unnecessary because the drug was already marketed. Indeed it was - for hypertension! A study of cardiovascular surgery in the UK - The consent dates were changed by overwriting to indicate that the patients had provided consent before the study started. A trained personal not involved in that specific trial can very well monitor that trial.
Please Sign in or Register to view further. Find out more Dismiss Cookie notice close icon. By The Editorial Team. Monitoring as a quality assurance activity Monitoring is a quality control measure put in place to ensure the integrity of trial data and protection of the rights and well-being of study participants is protected. Approach to monitoring Typically the sponsor appointed monitor conducts monitoring regular visits to the site according to an agreed upon monitoring plan. Also By. The Editorial Team. Nicodemus Nick Kisengese 12 May Gilbert Ogetii 14 May Omar Juma 1 Sep Tafireyi Marukutira 19 Feb Useful Resources Pharmacy and Product Accountability - presentation BY Administrator.
Even with the capacity development provided through MCTA, there is limited number of personnel with expertise in clinical trials across all the sites to meet the likely demands for evaluating new malaria interventions [ 18 ]. A long-term training framework for future clinical trialists is required to be able to achieve a critical mass of trialists at the sites and in the region. Nadia Tornieporth Sanofi Pasteur and Ms. Pedro Alonso, Prof. Brian Greenwood, Prof.
Application of GCP to the Conduct of Clinical Research
Kevin Marsh, Prof. Ogobara Doumbo, Prof. Marcel Tanner, Dr. Salim Abdulla, Dr. Seth Owusu-Agyei who offered their valuable time to visit the various sites and offered invaluable technical advice to site leaders and the MCTA secretariat. This article is published under license to BioMed Central Ltd. Skip to main content Skip to sections.
Advertisement Hide. Download PDF. Malaria Journal December , Cite as. Open Access. First Online: 20 April Background The Malaria Clinical Trials Alliance MCTA , a programme of INDEPTH network of demographic surveillance centres, was launched in with two broad objectives: to facilitate the timely development of a network of centres in Africa with the capacity to conduct clinical trials of malaria vaccines and drugs under conditions of good clinical practice GCP ; and to support, strengthen and mentor the centres in the network to facilitate their progression towards self-sustaining clinical research centres.
This process is experimental and the keywords may be updated as the learning algorithm improves. Background About one million African children die of malaria each year [ 1 ]. One of the early aims was to strengthen the sites in the network to contribute towards the development and evaluation of disease control interventions, including new drugs and vaccines [ 11 ].
It was set up to take advantage of site-site interactions to share best practices between centres. This was done by identifying centres with expertise in particular areas and facilitating sharing of that expertise with other centres. The main objectives of MCTA were to facilitate the timely development of a network of centres in Africa with the capacity to conduct clinical trials of malaria vaccines and drugs under conditions of GCP; and to support, strengthen and mentor the centres in the network to facilitate their progression towards self-sustaining clinical research centres.
To achieve these objectives, MCTA formed strategic partnerships with MMV and MVI, the two leading organizations established to catalyse the development of new anti-malarial drugs and vaccines respectively. MCTA site support focused on strengthening critical capabilities not commonly covered by clinical trial budgets, summarized in Table 2. MCTA has held an annual scientific meeting, with a specific theme each year.
This meeting brings together site leaders, mentors and the Board of Management to review the progress made and plans for the future. These are organised jointly with other partners with expertise in these areas to maximize resources utilization. A summary of the short courses organised to enable staff to acquire the necessary skills to conduct clinical trials and manage their sites effectively is given in Table 3. The workshops have all been over-subscribed.
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The need for in-depth understanding of GCP principles is made necessary by new requirements of funding agencies for GCP certification of Principal Investigators and study team members. This was followed by identification of good practices that could be shared across the Alliance.
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Some of the good practices included health and demographic surveillance HDSS for site characterization and study participant follow-up, management of severe malaria, data management, malaria diagnosis and certification of clinical trials professionals. The site visits revealed substantial disparities in the capacities of different centres and even supposedly well-established centres were found to have deficiencies that required urgent support to enable them be fully GCP compliant.
This brought to the fore the enormity of the resource needs to have GCP compliant platform meeting the regulatory standards. The difference in amounts is because equipment like X-ray was secured centrally and some of the requested resources were not for physical infrastructure support. The guided infrastructure support has been product development-driven and was performed in consultation with MMV and MVI. The guided support focused on what is critical to the execution of planned activities that are not likely to be covered by the clinical trial budget.
Table 4 Grants requested and disbursed for guided infrastructure development. Table 5 Grants disbursed for specific activities. Physical infrastructure 1. Capacity 1.
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Linking of capacity strengthening to specific intervention trials at the sites is essential to avoid mismatch with resultant redundant infrastructure 2. The quality of funding requests improved as the site teams engaged better with the secretariat with a focus on plans for sustainability 6. Int J Epidemiol. Am J Trop Med Hyg.webdisk.wcs2015.org/145-azithromycin-y.php
Q&A: Good clinical practice (GCP)
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