On 6 October 2016, the IMI GetReal project hosted a webinar “Identifying and addressing the operational challenges of pragmatic trials”. The webinar showcased GetReal’s Work Package 3 (WP3), providing guidance on the optimisation and feasibility of pragmatic trials. The webinar also presented PragMagic, a decision support tool being developed by WP3 to help researchers design pragmatic trials.

Rick Grobbee, Professor of Clinical Epidemiology at the University Medical Center Utrecht, started the webinar by discussing the uncertainties surrounding a new drug at the time of launch despite data from Randomised Clinical Trials (RCT) needed to get regulatory approval.

Patients included in phase III clinical trials may not be representative of the population to which the drug is eventually prescribed, and individual patient characteristics can modify the response to drugs, changing how a drug works under usual care conditions compared to RCTs. This is where Real World Evidence (RWE) can help, as RWE reflects the entire spectrum of patient responses.

However, how can we use RWE to assess safety and effectiveness of the drug as it happens in usual care to usual patients?

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GetReal aims to show how robust new methods of real-world evidence (RWE) collection and synthesis can be developed and considered for adoption earlier in pharmaceutical R&D and the healthcare decision making process. This will require companies, healthcare decision makers and other stakeholders to work together to generate a consensus on best practice in the use of RWE in regulatory and reimbursement decision-making.

Within work package 3 of GetReal we identified operational challenges when implementing pragmatic trials to investigate the effectiveness of medicines. We then proceeded to estimate the impact of these challenges on the ability to generate the RWE originally aimed for and the feasibility of the research. Lastly we provide guidance on how to design pragmatic trials while ensuring operational feasibility, most notably with a tool (development ongoing) guiding study teams through the design of a pragmatic trial. This webinar will give you an overview of all the above.