GetReal Trial Tool
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.
Why use the
GetReal Trial Tool?
Real-world evidence (RWE) is playing an increasing role in health care decisions. And so called pragmatic or Real World clinical trials can play an important role in generating evidence on the effectiveness of interventions.
Incorporating more Real World elements in trial design can improve the generalisability of trial results. However, the number of design choices you can make to gear 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”
Ensure you are making
the right choices
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.
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.
