IMI’s GetReal project has launched an innovative tool to aid in pragmatic clinical trial design. Pragmatic trials aim to capture the true effect of a treatment strategy in the real world. As such, they provide a great opportunity to generate real-world evidence in the early stages of drug development. However, pragmatic trials are still in their early days and designing them is far from easy.
GetReal designed the PragMagic tool in collaboration with gaming company IJsfontein. ‘In a user-friendly (and dare we say fun) way, PragMagic gives insight into the possible consequences of more pragmatic trial design choices and operational challenges on generalisability, risk of bias, precision, stakeholder & ethical acceptability, cost and duration,’ explained Mira Zuidgeest of the University Medical Center Utrecht. The project hopes that the new tool will increase the value and feasibility of pragmatic trials by informing stakeholders when designing and assessing pragmatic clinical trials. ‘The tool helps to balance the aim to be pragmatic with the feasibility of the trial and other implications of design choices such as validity of the trial results,’ said Dr Zuidgeest. For more information on the tool, visit the PragMagic website.
Incorporating data from ‘real life’ clinical settings into drug development and associated decision-making represents a serious challenge for pharmaceutical companies, regulators, and health authorities alike. By bringing together all key stakeholder groups (namely industry, academia, regulatory agencies, reimbursement agencies, healthcare budget holders, and patient groups) to share their insights and know-how, GETREAL will develop new approaches for incorporating real life data into drug development, and pave the way for a greater consensus on this issue.
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