Before considering a particular decision-making scenario you might like to review some general background material relevant to using real-world evidence (RWE) in medicine development. Choose from the menu of topics below:
- Decision-making perspective
- Development stages
- Effectiveness challenges
- Evidence development pathways
- Key important initiatives
- Policies and perspectives
- Impact of RWE on HTA re-assessment
There are a number of decision makers involved in medicines development. While GetReal primarily focuses on pharmaceutical research and development (R&D), regulatory and health technology assessment (HTA) perspectives, the patient perspective, clinician and local payer perspectives 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 (’effectiveness challenges’) may be faced.
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.
Key important initiatives
There have been a number of key initiatives which are relevant to the use of real-world evidence in medicines development.
Policies and perspectives
Read more about different stakeholders’ policies and perspectives on using real-world data for early drug development and relative effectiveness assessment.
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 it may help to gain a better understanding of the patient population who will receive a medicine; it may also help to better understand the relative effectiveness of medicines by supplementing evidence from conventional randomised controlled trials (RCTs).