Introduction to developing medicines

Before considering a particular decision-making scenario you might like to review some general background material relevant to using real-world evidence (RWE) in medicines development. Choose from the menu of topics below:

Decision-making perspective

There are a number of decision makers involved in medicines development. While GetReal primarily focused on pharmaceutical research and development (R&D), regulatory and health technology assessment (HTA) perspectives, the perspectives of patients, clinicians and local payers are also important.

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Development stages

Different stages of medicine development typically involve the use of different types of studies. Stages are typically referred to as 'early', 'mid', or 'late'.

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Effectiveness challenges

When evidence of effectiveness of a new medicine is presented to reimbursement or health technology assessment (HTA) agencies a variety of challenges may be faced. We call these ‘effectiveness issues’.

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Evidence development pathways

The combinations and sequences of studies that feature in a standard evidence development pathway for a medicine are primarily aimed at regulatory approval. Alternative pathways for studies may help improve the generation of evidence of relative effectiveness, which is of central importance to decision makers.

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Impact of RWE on re-assessment of medicines by HTA agencies

The use of real-world evidence (RWE) is important for access and reimbursement decisions for a number of reasons including that RWE may help to gain a better understanding of the patient population who will receive a medicine; RWE may also help to better understand the relative effectiveness of medicines by supplementing evidence from conventional randomised controlled trials (RCTs).

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