Expected Impact:
The action under this topic is expected to achieve the following impacts:
- greater benefit to patients from improved health care by ensuring that DHT-derived measures of how a patient feels and functions are accepted as patient-centred clinical-study endpoints;
- patients having improved access to innovations that meet their needs through the development of new and improved evidence-based methodologies for a more comprehensive assessment of the added value of innovative therapeutic drugs and technologies;
- better informed decision-making at all levels of the health care system (authorities, organisations) to facilitate cost-effective allocation of health resources, continuing innovation, and better health outcomes;
- greater understanding of the relationship between multiple patient-centred measurements including PPI, COAs, and DHT-derived measures and how these measures, when considered together, can provide greater insight into the patient perspective;
- reduced uncertainty regarding the PPI and COA data required to demonstrate the patient-relevance of DHT-derived clinical-study endpoints, and that needed to determine what constitutes a MCID in a patient-centred DHT-derived clinical-study endpoint for use in the development of pharmaceutical products, diagnostics, combination products, and therapeutic devices;
- improved and more efficient engagement between industry and stakeholders in the evaluation of technologies developed using patient-centred DHT-derived endpoints in clinical studies;
- increased speed and efficiency in the development and evaluation of
