Navigate your trial design

More informed decisions in trial design will lead to better results and better evidence.

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The GetReal Trial Tool offers you step by step guidance to evaluate the options and implications of introducing real world elements in clinical trial design.
Why use the GetReal Trial Tool
Real World Evidence (RWE) is playing an increasing role in health care decisions. Including more RWE elements in your trial design can improve the generalisability of trial results.

If designed and executed well, randomised clinical trials integrated into routine clinical practice (also called pragmatic trials) provide RWE on the value of a treatment strategy in usual care while maintaining the strength of randomisation. This benefits industry, healthcare providers and patients. However, the number of design choices you can make to tailor a clinical trial towards RWE is substantial, and all of these choices have consequences, both on a methodological and operational level.

“It allows you to assess the impact of design choices on generalisability of your clinical trial to routine clinical practice”

So how to ensure you are making the right choices for your clinical trial? What should your optimal clinical trial design look like, in light of your research question?

The GetReal Trial Tool offers you step by step guidance to evaluate the options and implications of introducing RWE elements in your trial design. It allows you to assess the impact of design choices on generalisability of your clinical trial to routine clinical practice, while taking into account other aspects of the trial, such as risk of bias, precision, acceptability and operational feasibility, as well.

Solid knowledge base for professionals in the field of clinical trial design and evaluation

The GetReal Trial Tool bundles the knowledge of over 100 professional experts from pharmaceutical companies, academia, HTA agencies, patient organisations, and regulators. This tool offers you an accessible and solid knowledge base to assess, design or discuss clinical trials in the light of RWE generation.
The content of the tool is based on a combination of extensive literature review (references are provided in the tool, see also our open access paper series on pragmatic trials), in-depth stakeholder interviews, pragmatic trial study team conversations, and consortium member input, and has been validated by a team of professors, clinical trial (operational) experts and epidemiologists.

The GetReal Trial Tool is open access
The tool can be used without entering any real trial information. You can also use the tool to create projects and make notes, which you can save to revisit at a later stage.
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Funding:

The research leading to these results has received support from the EU/EFPIA Innovative Medicines Initiative 2 Joint Undertaking GetReal Initiative under grant agreement No 807012.