Assessing the Financial Value of Patient Engagement: A Quantitative Approach from CTTI’s Patient Groups and Clinical Trials Project

Assessing the Financial Value of Patient Engagement: A Quantitative Approach from CTTI’s Patient Groups and Clinical Trials Project Assessing the Financial Value of Patient Engagement: A Quantitative Approach from CTTI’s Patient Groups and Clinical Trials Project | Article “In a 2017 article, a novel approach was introduced for assessing the Read more…

Enhancing Benefit-Risk Assessment in Regulatory Decision-Making

Enhancing Benefit-Risk Assessment in Regulator Decision-Making Enhancing Benefit-Risk Assessment in Regulatory Decision-Making | FDA An FDA guidance intended to clarify for drug sponsors and other stakeholders how considerations about a drug’s benefits, risks, and risk management options factor into certain premarket and postmarket regulatory decisions that the Agency makes about Read more…

ICH Reflection Paper: Proposed ICH Guideline Work to Advance Patient Focused Drug Development

ICH Reflection Paper: Proposed ICH Guideline Work to Advance Patient Focused Drug Development ICH Reflection Paper: Proposed ICH Guideline Work to Advance Patient Focused Drug Development | ICH Importance of bringing patient perspective in clinical research a series of drug development and regulatory decision-relevant questions that arise during the drug Read more…