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
- Development stages
- Effectiveness challenges
- Evidence development pathways
- Impact of RWE on HTA re-assessment
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.
Different stages of medicine development typically involve the use of different types of studies. Stages are typically referred to as 'early', 'mid', or 'late'.
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’.
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.
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).