39 results on '"Schiel, Anja"'
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2. Generating the right evidence at the right time: Principles of a new class of flexible augmented clinical trial designs
3. The use of external controls: To what extent can it currently be recommended?
4. Modified study designs to expand treatment options in personalised oncology: a multistakeholder view
5. Setting International Standards in Analyzing Patient-Reported Outcomes and Quality of Life Endpoints in Cancer Clinical Trials-Innovative Medicines Initiative (SISAQOL-IMI): stakeholder views, objectives, and procedures
6. Single-arm studies involving patient-reported outcome data in oncology: a literature review on current practice
7. An Inclusive Civil Society Dialogue for Successful Implementation of the EU HTA Regulation: Call to Action to Ensure Appropriate Involvement of Stakeholders and Collaborators
8. Regulatory and Health Technology Assessment Considerations for Disease-Modifying Drugs in Alzheimer’s Disease
9. The role of stakeholder involvement in the evolving EU HTA process: Insights generated through the European Access Academy’s multi-stakeholder pre-convention questionnaire
10. Setting International Standards in Analyzing Patient-Reported Outcomes and Quality of Life Endpoints in Cancer Clinical Trials-Innovative Medicines Initiative (SISAQOL-IMI): stakeholder views, objectives, and procedures
11. Single-arm studies involving patient-reported outcome data in oncology: a literature review on current practice
12. The role of stakeholder involvement in the evolving EU HTA process: Insights generated through the European Access Academy's multi-stakeholder preconvention questionnaire.
13. Multi-Arm, Multi-Drug Trials from a Reimbursement Perspective
14. Generating the Right Evidence at the Right Time: Principles of a New Class of Flexible Augmented Clinical Trial Designs
15. Commentary on “Target estimands for population‐adjusted indirect comparisons”
16. A framework for assessing the impact of accelerated approval
17. Estimands and Complex Innovative Designs
18. The Impact of COVID‐19 on the Initiation of Clinical Trials in Europe and the United States
19. Assessment of tumour-agnostic therapies in basket trials
20. Can we use existing guidance to support the development of robust real-world evidence for health technology assessment/payer decision-making?
21. The use of external controls: To what extent can it currently be recommended?
22. Collaborative Platform Trials to Fight COVID‐19: Methodological and Regulatory Considerations for a Better Societal Outcome
23. Towards a better use of scientific advice for developers of advanced therapies
24. Single‐Arm Clinical Trials as Pivotal Evidence for Cancer Drug Approval: A Retrospective Cohort Study of Centralized European Marketing Authorizations Between 2010 and 2019
25. Current Statistical Considerations and Regulatory Perspectives on the Planning of Confirmatory Basket, Umbrella, and Platform Trials
26. Can we use existing guidance to support the development of robust real-world evidence for health technology assessment/payer decision-making?
27. Towards a better use of scientific advice for developers of advanced therapies.
28. The impact of parallel regulatory–health technology assessment scientific advice on clinical development. Assessing the uptake of regulatory and health technology assessment recommendations
29. Recognizing that Evidence is Made, not Born
30. The impact of parallel regulatory-health technology assessment scientific advice on clinical development. Assessing the uptake of regulatory and health technology assessment recommendations
31. Activated Platelets Release Two Types of Membrane Vesicles: Microvesicles by Surface Shedding and Exosomes Derived From Exocytosis of Multivesicular Bodies and α-Granules
32. Alternatively spliced forms of the human myeloid Fcα receptor (CD89) in neutrophils
33. Intrauterine Exposure to Maternal Atherosclerotic Risk Factors Increases the Susceptibility to Atherosclerosis in Adult Life
34. Microarray analysis reveals pivotal divergent mRNA expression profiles early in the development of either compensated ventricular hypertrophy or heart failure
35. Induction of Thyroid Hormone-Degrading Deiodinase in Cardiac Hypertrophy and Failure
36. Activated Platelets Release Two Types of Membrane Vesicles: Microvesicles by Surface Shedding and Exosomes Derived From Exocytosis of Multivesicular Bodies and -Granules
37. Alternatively spliced forms of the human myeloid Fc&; receptor (CD89) in neutrophils
38. Perspectives on a Way Forward to Implementation of Precision Medicine in Patients With Diabetic Kidney Disease; Results of a Stakeholder Consensus-Building Meeting.
39. Activated Platelets Release Two Types of Membrane Vesicles: Microvesicles by Surface Shedding and Exosomes Derived From Exocytosis of Multivesicular Bodies and ?-Granules
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