Capacity Building in a New Clinical Trials Network Through Inter-Network Collaboration

Author(s):  
Lisa Knight ◽  
Barbara A. Pahud ◽  
Margaret Scheffler ◽  
Joshua C. Euteneuer ◽  
Christine Allen ◽  
...  
2019 ◽  
Vol 4 (Suppl 3) ◽  
pp. A45.1-A45
Author(s):  
Harry Van Loen ◽  
Diana Arango ◽  
Hanne Landuyt ◽  
Christophe Burm ◽  
Yven Van Herrewege

BackgroundAccurate and timely data management (DM) is of key importance in clinical research to generate high-quality and GCP-compliant data for analysis and/or sharing. Our objective is to strengthen the capacity for DM in clinical research in resource-poor settings by organising several teaching initiatives.MethodsOur teaching initiatives have a twofold approach. First, a generic and comprehensive approach with capacity building on various thematical modules. These include a research component (overviewing the research data management procedures) and a technological component (introducing databases and software). In addition, a component on legislation, guidelines and standards specific towards DM is discussed, as well as a project management component on how to organise DM efficiently and timely. Second, we apply a more focused and study-specific approach which details roles and responsibilities in data management, milestones and documentation practices. Both approaches are based upon successful implementation in EDCTP-funded clinical trials, such as the 4ABC, PREGACT and Microbicide Safety Biomarkers studies, as well as the FP7 sponsored NIDIAG project. The target audience comprises various study stakeholders such as data managers, IT administrators, clinicians, laboratory researchers and statisticians, coming from sub-Saharan Africa, South-East Asia and Latin America.ResultsA teaching model for promoting Good Data Management Practices has been developed with theory- and practice-based modules. This model is used at face-to-face workshops in remote settings and has been re-used by colleagues and implemented by other research institutions to promote further capacity building and sustainable development in the South. In addition, it has led to mutual learning and enhanced institutional and personal North-South collaborations.ConclusionThere is a clear case for promoting DM and providing guidelines for Good Data Management Practices. Our twofold approach has enabled the successful conduct of GCP compliant non-commercial clinical trials in the South.


2020 ◽  
Vol 9 (1) ◽  
Author(s):  
Yu-Hong Liu ◽  
Shu Chen ◽  
Jing-Tao Gao ◽  
Yao Zhang ◽  
Kimberly Booher ◽  
...  

2018 ◽  
Vol Volume 10 ◽  
pp. 151-155
Author(s):  
Lawrence Mbuagbaw ◽  
Amy Slogrove ◽  
Jacqueline Sas ◽  
John Lengwe Kunda ◽  
Frederick Morfaw ◽  
...  

2020 ◽  
Vol 20 (1) ◽  
Author(s):  
Atara Ntekim ◽  
Abiola Ibraheem ◽  
Adenike Adeniyi-Sofoluwe ◽  
Toyosi Adepoju ◽  
Mojisola Oluwasanu ◽  
...  

2021 ◽  
Vol 9 ◽  
Author(s):  
Robert D. Annett ◽  
Scott Bickel ◽  
John C. Carlson ◽  
Kelly Cowan ◽  
Sara Cox ◽  
...  

Introduction: Research capacity building is a critical component of professional development for pediatrician scientists, yet this process has been elusive in the literature. The ECHO IDeA States Pediatric Clinical Trials Network (ISPCTN) seeks to implement pediatric trials across medically underserved and rural populations. A key component of achieving this objective is building pediatric research capacity, including enhancement of infrastructure and faculty development. This article presents findings from a site assessment inventory completed during the initial year of the ISPCTN.Methods: An assessment inventory was developed for surveying ISPCTN sites. The inventory captured site-level activities designed to increase clinical trial research capacity for pediatrician scientists and team members. The inventory findings were utilized by the ISPCTN Data Coordinating and Operations Center to construct training modules covering 3 broad domains: Faculty/coordinator development; Infrastructure; Trials/Research concept development.Results: Key lessons learned reveal substantial participation in the training modules, the importance of an inventory to guide the development of trainings, and recognizing local barriers to clinical trials research.Conclusions: Research networks that seek to implement successfully completed trials need to build capacity across and within the sites engaged. Our findings indicate that building research capacity is a multi-faceted endeavor, but likely necessary for sustainability of a unique network addressing high impact pediatric health problems. The ISPCTN emphasis on building and enhancing site capacity, including pediatrician scientists and team members, is critical to successful trial implementation/completion and the production of findings that enhance the lives of children and families.


2018 ◽  
Vol 13 (5) ◽  
pp. 486-493 ◽  
Author(s):  
Patrick T. Wilson ◽  
Katie Giessler ◽  
Marilyn C. Morris

Conducting clinical trials in resource-poor settings may contribute to local capacity building. We describe the perspectives of local research personnel regarding the impact of collaborating in a clinical trial in rural Ghana. Forty-six Ghanaian research personnel were eligible to complete an anonymous survey, and 35 (76%) participated. Of the 35 respondents, 32 (91%) agreed that future patients will benefit because the hospital was part of the study. All 35 respondents reported a personal benefit derived from study involvement, most commonly citing skills or knowledge gained. Of the 35 individuals, 21 reported one or more burdens, most commonly citing nonspecific research responsibilities. Our data support the hypothesis that participation in clinical trials can contribute to capacity building in district hospitals in a lower middle-income country.


Author(s):  
D. C. Swartzendruber ◽  
Norma L. Idoyaga-Vargas

The radionuclide gallium-67 (67Ga) localizes preferentially but not specifically in many human and experimental soft-tissue tumors. Because of this localization, 67Ga is used in clinical trials to detect humar. cancers by external scintiscanning methods. However, the fact that 67Ga does not localize specifically in tumors requires for its eventual clinical usefulness a fuller understanding of the mechanisms that control its deposition in both malignant and normal cells. We have previously reported that 67Ga localizes in lysosomal-like bodies, notably, although not exclusively, in macrophages of the spocytaneous AKR thymoma. Further studies on the uptake of 67Ga by macrophages are needed to determine whether there are factors related to malignancy that might alter the localization of 67Ga in these cells and thus provide clues to discovering the mechanism of 67Ga localization in tumor tissue.


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