ADDIS: Software for Clinical Trials Data Analysis
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1 using aggregate data within the framework of BR-assessment 12 October, 2009
2 What are we building? Build a comprehensive information system That stores efficacy and safety information On a wide variety of drugs Enable automated comparisons between drugs Is the drug as effective and/or as safe as approved drugs? Identify benefits and risks, trade-offs Is the drug suitable for all targeted sub-populations?
3 Motivation Systematically assessing a new drug application in the context of pre-existing evidence is difficult: 1 Evidence hard to find, combine 2 How to apply evidence is unclear (e.g., efficacy vs safety) 3 BR-analysis helps (2), but makes (1) worse Next slides illustrate workflows.
4 Meta-Analysis: Workflow
5 Benefit-Risk Analysis: Workflow
6 Model-Driven Workflow
7 Aggregate Data Drug Information System (ADDIS) v0.2 Try it yourself! drugis.org
8 Work So Far: ADDIS v0.2
9 ADDIS: Agile Software Development Start ++knowledge Identify core features Feedback Develop ++interest Release
10 ADDIS v0.2: Open Source Software
11 Supporting Website: drugis.org
12 Regulatory Use Case Known: The following Non-Inferiority relations: D 2 D 3 D 4 D 5 D 6
13 Regulatory Use Case Drug Application: Drug D 1. D 1 D 2 D 3 D 4 D 5 D 6
14 Regulatory Use Case Provided study: D 1 not inferior ( ) D 2. D 1 D 2 D 3 D 4 D 5 D 6 How to decide if D 1 is acceptable?
15 The Easy Case D 1 D 2 D 3 S 1 o o S 2 o o S 3 o o S 4 o o If we want to compare two drugs, say D 1 and D 2, it is easy:
16 The Easy Case D 1 D 2 D 3 S 1 x x S 2 o o S 3 x x S 4 o o If we want to compare two drugs, say D 1 and D 2, it is easy: 1 Select the studies that measure both D 1 and D 2
17 The Easy Case D 1 D 2 D 3 S 1 x x S 2 o o S 3 x x S 4 o o If we want to compare two drugs, say D 1 and D 2, it is easy: 1 Select the studies that measure both D 1 and D 2 2 Pool efficacy data from these studies to get an effect estimate
18 Problem: Indirect Comparison? D 1 D 2 D 3 S 1 o o S 2 o o S 3 o o Can we compare D 1 to D 3?
19 Problem: Comparing > 2 Drugs D 1 D 2 D 3 S 1 o o S 2 o o S 3 o o S 4 o o If we want to compare D 1... D 3 :
20 Problem: Comparing > 2 Drugs D 1 D 2 D 3 S 1 x x S 2 x x S 3 x x S 4 x x If we want to compare D 1... D 3 : 1 Select the studies that measure at least two of D 1... D 3
21 Problem: Comparing > 2 Drugs D 1 D 2 D 3 S 1 x x S 2 x x S 3 x x S 4 x x If we want to compare D 1... D 3 : 1 Select the studies that measure at least two of D 1... D 3 2 How do we combine this data?
22 The (iediate) future of ADDIS ADDIS v0.4 to be released Two additional prograers starting Focus on toolkit for meta-analysis Research looking further ahead To more advanced applications/features
23 Conclusions Using RCT data through evidence synthesis difficult: Lack of structured (meta-)data on studies Lack of automated tools ADDIS will provide A way to store studies in a machine-readable way Automated tools for meta-analysis and BR-analysis My research will likely focus on new approaches to evidence synthesis for drug benefit-risk assessment
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