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International Clinical Trials

Imaging Innovations

In every clinical trial, data rules. In trials for treatments of solid cancerous tumours, much of that critical data relates to the size, type, and appearance of new lesions, whether used as eligibility criteria or as safety or efficacy endpoints. The importance of having clean, accurate measures and objective interpretations of those measures to the success of an oncology trial cannot be overstated.

Ensuring the validity of imaging data points in oncology trials is particularly challenging due to the complexity and variability in acquiring and assessing images. Protocols must set forth the choice of imaging modality, the image acquisition parameters, and the specific protocol for the IV contrast or oral contrast. This will enable the application of more than 10 different assessment criteria.

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Sophie Winandy is Product Manager at ERT and has more than 10 years of experience working closely with clinical trial sponsors and CROs to identify and implement optimal imaging approaches that accelerate the development of new medical products. Drawing on her training as a Registered Technologist, Magnetic Resonance Imaging, Sophie helped to develop the imaging solutions employed by researchers across hundreds of clinical trials during her tenure at Biomedical Systems (acquired by ERT in 2017).
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Sophie Winandy
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Conveying Medical Guidance in Clinical Trials – A Survey

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With the incremental demand for proactive safety surveillance throughout the conduct of clinical trials, the role of Medical Management is at the fore in ensuring the safety and wellbeing of the participants. The complex responsibilities of a Medical Monitor (MM) starts from the design and development phase, through to study close out. Understanding the principle behind the protocol and the prospective medical solution the study would deliver forms the bloodline for the MM role. Often, the MM is the face of contact for both the site personnel and the study team members with regard to medical, safety and scientific issues within the project. When it comes to medical guidance, the communication channel used to deliver solutions contributes to a large extent in effectively managing decisive situations. Our previous study on acquiring medical guidance from an operations team perspective revealed that e-mails were the most used communication method (see the article, 'Talking Points', in ICT November 2014). In our efforts to further strengthen the mode of medical guidance delivery, we designed a survey to study the existing trend and constraints in this communication chain management, as outlined here.
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