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.
The tool is open access. It can be used without entering any real trial information.
The tool is open access. It can be used without entering any real trial information.
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.
Disclaimer and Privacy
Disclaimer and Privacy
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.
