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… New FDA Draft Guidance For Evaluating Patient-Reported Outcomes in Clinical Trials Share on: September 3, 2020 On August 31, 2020, the FDA released its draft guidance … by considering the similarities and differences between the population in the pivotal clinical study (e.g., …
… RTI Recognized with 2020 Cigna Well-Being Award Cigna has selected RTI … Well-Being Award for demonstrating a strong commitment to improving the health and well-being of its employees through … is the result of ongoing cross-institute collaborations between our facilities, communications, and regional office …
… Expanding the Use of Inclusive Language in Medical Writing … research, there are important conceptual differences between these terms that writers should be aware of in their … that “language and culture are fluid, so we know that this guidance will need to be updated as terminology and norms …
… from Working with Newest AMCP Format Guidance During 2020 In December of 2019, the Academy of Managed Care … the inclusion of clinical data affect planned or pending publications? Manufacturers should determine the appropriate … references to the dossier as they become available, thus expanding the dossier organization and content to reflect the …
… FDA and AMCP Guidance on Pre-Approval Submissions and the Continuous … from Phase 1, Phase 2, and Phase 3 studies (peer-reviewed publications; congress abstracts, posters, and presentations; … Disease information Product information Version 4.1 (2020) At the October 2019 AMCP Nexus meeting, the AMCP Format …
… FDA Draft Guidance: Crucial Advancement Toward More Inclusive Clinical … vary among different ethnic groups, just as they do between sexes. Research shows that there are differences in … underrepresented populations in clinical studies, thereby improving the generalizability and robustness of clinical …
Psychometric Evaluation Our psychometricians have extensive experience conducting quantitative evaluations of COAs, evaluating their structure and demonstrating their reliability, validity, and responsiveness, as well as facilitating the interpretation of …
… Final FDA Guidance on Real-World Data and Real-World-Evidence for Drug … Food and Drug Administration (FDA) has now released final guidance about using real-world evidence (RWE) to support regulatory decision-making that includes …
… including: Literature and instrument reviews to guide COA selection and/or to determine that instrument … trial design and consulting to optimize the analysis of COA data, as well as the value of results based on COA endpoints Gap analysis of data supporting the use of COAs …
… team of cross-functional experts can provide you with the guidance you need to synthesize, summarize, and confidently … common understanding, increased transparency, and improved communication about your product’s benefit-risk profile. A … approach can improve your evidence generation and communication strategy Incorporating patient and/or provider …