Why your immunology portfolio needs a patient-centered real-world study
Patient-centered real-world research should be an essential part of the evidence development strategy for an immunology portfolio. Here, we discuss how this type of research can add particular value in autoimmune and immune-mediated diseases. Accurate measurement of...
Designing patient-centered registries to support regulatory decision-making
According to the FDA, a registry can be defined as “an organized system that collects clinical and other data in a standardized format for a population defined by a particular disease, condition, or exposure”1. Disease registries can be useful ways to: understand the...
Below the surface: NICE’s quality standards in skin cancer
The National Institute for Health and Care Excellence (NICE) is developing guidance to update the quality standard in skin cancer, which covers the prevention, assessment, diagnosis, and management of malignant and non-malignant melanoma. The draft quality standard is...
Ethics in patient-centered real-world studies: what, when, and who?
What do we mean by ethics? Ethics are principles or standards that guide behavior. Aligning research processes to ethical guidelines protects research participants’ rights and welfare, ensuring that researchers: act in the best interest of participants consider and...
