Engagement of all the stakeholder groups into the upcoming consensus study is the cornerstone of any Core set of outcomes as it enables a well-balanced decision-making process. Industry representatives and regulators are an important stakeholder group whose involvement in the process is necessary. With certain health outcomes being recognized by these stakeholders, the inclusion of such in clinical trials may impact regulatory decisions, substantiating their consideration in the consensus study. We encourage you to attract representatives of the industry and regulatory authorities by referring them to COMFA and initiating further discussions should that be necessary. Please contact Daniel Munblit if you would like to establish contact with a representative within your network via email.