Safety reporting in developing country vaccine clinical trials—A systematic review

Muehlhans, Susann; Richard, Georgina; Ali, Mohammad; Codarini, Gabriela; Elemuwa, Chris; Khamesipour, Ali; Mäurer, W; Mworozi, Edison; Kochhar, Sonali; Rundblad, Gabriella; Vuitton, Dominique A.; Rath, Barbara

doi:10.1016/j.vaccine.2012.02.059

Cited by 21 publications

(19 citation statements)

References 84 publications

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“…The ability to ascertain suspected adverse events at the point of care opens new avenues for safety surveillance [8,21,24]. Large datasets derived from post-marketing surveillance provide sufficient power to detect rare adverse events that may have gone unnoticed during pre-licensure trials with limited enrollment numbers [48].…”

Section: Discussionmentioning

confidence: 99%

“…Multiple studies have shown that spontaneous reports are often lacking the level of detail required for comprehensive evaluation at public health agencies and regulatory authorities [7][8][9][10][11].…”

Section: Introductionmentioning

confidence: 99%

“…In an effort to harmonize ascertainment procedures internationally, consensus case definitions have been published for various adverse events, designed to be independent of a presumed trigger [26][27][28]. These case definitions are readily available, but seldom put to use [8,21].…”

Section: Introductionmentioning

confidence: 99%

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Innovative Digital Tools and Surveillance Systems for the Timely Detection of Adverse Events at the Point of Care: A Proof-of-Concept Study

et al. 2016

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Section: Discussionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

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Innovative Digital Tools and Surveillance Systems for the Timely Detection of Adverse Events at the Point of Care: A Proof-of-Concept Study

et al. 2016

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“…In a systematic review of 50 randomized controlled vaccine trials in developing aon consistent documentation being key to the successful implementation of international safety standards in resource poor settings. [5] Modern technologies including Short Message Service (SMS) and mobile phone applications were recommended as possibly facilitating the monitoring of vaccine safety in remote areas where access to internet connectivity may not always be possible. [5] This technology would allow for real time data collection, offering an improvement on collection using a hardcopy tool.…”

Section: Vaccine Uptake and Efficacymentioning

confidence: 99%

“…[5] Modern technologies including Short Message Service (SMS) and mobile phone applications were recommended as possibly facilitating the monitoring of vaccine safety in remote areas where access to internet connectivity may not always be possible. [5] This technology would allow for real time data collection, offering an improvement on collection using a hardcopy tool. Standardisation of safety reporting across multiple sites in developing countries was borne out in a systematic review of safety data reporting in vaccine trials for malaria, tuberculosis and HIV, which focused partly on methods used to collect and report side effects.…”

Section: Vaccine Uptake and Efficacymentioning

confidence: 99%

(pMOTAR): A Pilot Study of Mobile Technology to Assess Reactogenicity (Preprint)

Mngadi¹,

Maharaj²,

Duki³

et al. 2017

Preprint

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BACKGROUND Accurate safety monitoring in HIV vaccine trials is vital to eventual licensure and consequent uptake of products. Current practice is to capture related side effects in a hardcopy tool, reconciled post vaccination, which is time-consuming, laborious and fraught with error. Unstructured Supplementary Service Data (USSD), commonly used to purchase airtime, has been suggested for collection of safety data in vaccine trials. With saturated access to mobile phones in South Africa, this cheap, accessible tool, may improve accuracy and completeness of collected data, and prove feasible and acceptable over the hardcopy tool. OBJECTIVE To develop and implement an USSD tool for real time safety data collection, that is feasible and acceptable to participants and staff, allowing for a completeness and accuracy comparison with the hardcopy tool. METHODS This pilot study of Mobile Technology to Assess Reactogenicity (pMOTAR) is being conducted at a single study site in South Africa enrolling participants in a phase 1/2a preventive HIV vaccine trial, as an open-label, randomised controlled trial, to all consenting HVTN 108 participants who continue to receive vaccinations. Participants are randomised 1: 1 to the hardcopy or USSD tool, with data collection targeted to the 3rd and 4th injections in the parent trial. Online feasibility and acceptability surveys will be completed by staff and participants at the post-vaccination visit. Error rates between the hardcopy tool and the USSD print-out and associated documentation will be itemised and compared. We hypothesize that the USSD tool will be shown to be feasible and acceptable to staff and participants and to have superior quality and completion rates to the hardcopy tool. RESULTS The study has received regulatory approval. The USSD tool has been designed and developed to include all the data fields required for reactogenicity reporting. Online feasibility and accessibility surveys in both languages have been successfully installed on a tablet. The study has been initiated. CONCLUSIONS Several HIV preventive vaccine trials are currently active in Southern Africa, making tools to improve efficiencies and minimise error necessary. Our results will help to determine if the USSD tool can be used in future vaccine studies and eventual roll out.

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Awareness and Utilization of Reporting Pathways for Adverse Events Following Immunization: Online Survey Among Pediatricians in Russia and Germany

et al. 2014

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Safety reporting in developing country vaccine clinical trials—A systematic review

Cited by 21 publications

References 84 publications

Innovative Digital Tools and Surveillance Systems for the Timely Detection of Adverse Events at the Point of Care: A Proof-of-Concept Study

Innovative Digital Tools and Surveillance Systems for the Timely Detection of Adverse Events at the Point of Care: A Proof-of-Concept Study

(pMOTAR): A Pilot Study of Mobile Technology to Assess Reactogenicity (Preprint)

Awareness and Utilization of Reporting Pathways for Adverse Events Following Immunization: Online Survey Among Pediatricians in Russia and Germany

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