M3 and Real World Studies

Vital research that provides context and value to clinical trial results.

‘Real world’ evidence or data studies are increasingly popular market research methodologies used to examine real patient data. This information is analysed alongside their opinions about treatment and management of the condition.

Real world data gives insight into daily clinical practices outside of the scope of clinical trials. This methodology captures data provided through patient record forms (PRFs) and patient self-completion questionnaires (PSCs) about medication usage and potential risks. PRFs are completed by physicians referencing patient files. To limit bias, patients are asked complete PSCs without a physician present. Information from all sources is anonymised, and physicians don’t see their patients’ responses.

Real world methodologies complement the work of clinical trials by providing a larger evidence base and context. Clinical trials are often biased towards younger patients which may not match the reality of patients needing a crucial treatment. Real world studies fill that gap and provide highly relevant insights to physicians.

Real World studies

For physicians working in practices where an electronic health record system is used, completing patient record forms (PRFs) is easier. Digitised information is readily available at the click of a button. For non-digitised records, the process may be more time consuming, especially when access to lab results is limited. For these reasons, estimates for the length of time to complete PRFs are not as precise as other M3 time estimates.

Often times, the instructions in a study ask that patients complete their part of the survey without any help, but in practise that’s not always possible, and the doctor has to explain small parts of the survey. Researchers do their best to make sure that questions are easy to understand so that patients can complete their survey without physician assistance. In PSCs, patients are able to write honestly about their experiences with the treatment and care they’ve received. The questions only ask patients about the impact of their condition on their daily life.


For patients, being involved in real world data studies means that their opinions are given much more prominence in the research and development of new therapies and medications. Patients are also able to anonymously share their first-hand experience of living with a particular condition or disease with physicians.  Patient involvement is crucial in medical education as well. For conditions such as haemophilia, data about patients’ everyday life is scarce, so real world responses are often enlightening for healthcare professionals.

Many physicians take part in real world studies to receive the outputs of data that helps them improve their own clinical practice. Widening their knowledge about how their patients experience life will help physicians and healthcare professionals understand more about alternative treatments, potential barriers to treatment, and how patient care could be improved.

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