Harmonized Data Quality Indicators Maintain Data Quality in Long-Term Safety Studies Using Multiple Sclerosis Registries/Data Sources: Experience from the CLARION Study.

Purpose: Understanding the long-term safety of disease-modifying therapies for multiple sclerosis (MS) in routine clinical practice can be undertaken through registry-based studies. However, variability of data quality across such sources poses the challenge of data fit for regulatory decision-making. CLARION, a non-interventional cohort safety study of cladribine tablets, combines aggregated data from MS registries/data sources, except in Germany (which utilizes primary data collection).

Drug Utilization Studies in Pregnant Women for Newly Licensed Medicinal Products: A Contribution from IMI ConcePTION.

Purpose: Studies focusing on safety outcomes typically require large populations to comprehensively characterise the patient groups exposed to the medicines under investigation. However, there is often less information for subpopulations, such as pregnant or breastfeeding women, particularly when new medicines are considered. It is important to understand what information can be obtained from drug utilization studies (DUS) involving pregnant women in the early years postmarketing to provide supportive information for safety studies.

Improving Data Collection in Pregnancy Safety Studies: Towards Standardisation of Data Elements in Pregnancy Reports from Public and Private Partners, A Contribution from the ConcePTION Project.

Introduction And Objective: The ConcePTION project aims to improve the way medication use during pregnancy is studied. This includes exploring the possibility of developing a distributed data processing and analysis infrastructure using a common data model that could form a foundational platform for future surveillance and research. A prerequisite would be that data from various data access providers (DAPs) can be harmonised according to an agreed set of standard rules concerning the structure and content of the data.

Bone mass, fracture risk, and associated factors in postmenopausal women living with HIV.

Objective: The aim of this study was to assess the prevalence of low bone mass (osteopenia/osteoporosis), the factors associated with low bone mass, and the risk of fractures in Brazilian postmenopausal women living with HIV (WLH) in the Amazon region.

Methods: This is a cohort study with a cross-sectional assessment at baseline conducted between March 2021 to August 2022 with 100 postmenopausal WLH undergoing antiretroviral therapy (ART) between 45 and 60 years of age and 100 age-matched HIV-negative women. Data on bone mineral density in the lumbar spine (LS) and femoral neck (FN) were collected using dual x-ray absorptiometry and the 10-year risk of hip and major osteoporotic fractures was assessed using the Fracture Risk Assessment tool (FRAX).