Industry news round-up: updates from June 2024
Discover the latest industry developments in real-world data (RWD) and real-world evidence (RWE) as reported in The Evidence Base from June 2024 in our regular monthly column.
Second implementing act for the EU HTA Regulation details rules on conflicts of interest
Swiftly following adoption of the first implementing act, the second act outlining procedural rules for assessing and managing conflicts of interest is now open for consultation.
CIOMS publishes report on real-world evidence in regulatory decision-making
The Council for International Organizations of Medical Sciences (CIOMS) has released a comprehensive report, detailing the use of RWD and RWE in regulatory decision-making.
Clarivate and HealthWise Data partner to enhance real-world data with social determinants of health
Clarivate partners with HealthWise Data to integrate Social Determinants of Health (SDoH) into its RWD, enhancing patient insights and promoting healthcare equity for better outcomes.
NICE has updated its RWE framework to incorporate new methodologies for enhancing the external validity and transportability of RWD. This update aims to ensure the framework reflects the latest advancements in RWE.
Health Outcomes Observatory launches pan-European initiative to improve evidence-based health care
The pan-European Health Outcomes Observatory will leverage patient-reported outcomes to enhance health care and research across Europe.
The two companies are collaborating to offer a streamlined solution that combines primary study data, captured on THREAD’s platform, with RWD available through SEQSTER’s patient-centric operating system.
Parexel announces partnership with Ruijin Hainan Hospital to progress real-world evidence in China
Working with Ruijin Hainan Hospital, Parexel will utilize the Hainan Real World Evidence Pathway program to facilitate the collection and analysis of RWD, thereby accelerating the approval and availability of new treatments for patients in China.
RWE4Decisions is seeking feedback on a set of draft actions recommended for various stakeholder groups to develop the use of RWE to inform healthcare decisions made by health technology assessment (HTA) bodies and payers.
Two new guidance documents published for joint clinical assessments in Europe
The Member State Coordination Group on Health Technology Assessment has adopted two new guidance documents advancing joint clinical assessments in Europe under the EU Health Technology Assessment Regulation.
ISPOR—The Professional Society for Health Economics and Outcomes Research has announced publication of the SUITABILITY Checklist to evaluate electronic health record (EHR) data for HTA, focusing on data quality, fitness-for-purpose, and governance.
HealthVerity launches taXonomy dataset for pharmaceutical and real-world evidence research
HealthVerity‘s taXonomy is a comprehensive, HIPAA-compliant closed claims dataset for pharmaceutical research, providing extensive patient data and standardized costs, to advance RWE research.
FDA releases new draft guidance to enhance diversity in clinical trials
The US Food and Drug Administration (FDA) has issued draft guidance to increase underrepresented population enrollment in clinical trials, enhancing data relevance and patient representation.
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