Best Practices for Medical Information Global Response Documents from phactMI and MILE

Medical information departments within pharmaceutical companies play a critical role in addressing unsolicited healthcare professionals' inquires with accurate, evidence-based, and balanced medical information through scientific response documents. Global response documents (GRDs) aim to harmonize information between global and local teams and the end product, the scientific response document. To address the challenges associated with the development and maintenance of global response documents and this harmonization, phactMI and Medical Information Leaders Europe (MILE) convened an international expert panel representing 11 major pharmaceutical companies. Over months of discussion and deliberation, the panel developed consensus-based best practices for the creation and management of global response documents. The experts contributed nuanced insights regarding optimal document structure and format that consider various stakeholders while maintaining medical accuracy. Consensus was achieved via a structured survey with a 75% approval threshold for each best practice. Overall, GRDs are essential tools for pharmaceutical companies, offering accurate evidence-based responses to healthcare professionals. While companies may respond to patient inquiries as well in different formats (verbal vs written), GRDs are exclusively intended for healthcare professionals currently. Best practices for GRD development include: being focused on a single topic, developed in a label-agnostic manner, utilize the most robust scientific information available, developed up to 12-15 months prior to launch, have regular feedback in a structured approach from local teams, follow internal guidelines and work instructions, and be peer reviewed internally whenever new data are added. In addition, local response documents or scientific response documents should be based on a GRD that is localized with appropriate documentation. Overall, GRD development is a collaborative and innovative approach (including interactive formats), supported by defined metrics (including response time) and ongoing updates to ensure global relevance and compliance.