Increase transparency and reproducibility of real-world evidence in rare diseases through disease-specific Federated Data Networks.

Purpose: In rare diseases, real-world evidence (RWE) generation is often restricted due to small patient numbers and global geographic distribution. A federated data network (FDN) approach brings together multiple data sources harmonized for collaboration to increase the power of observational research. In this paper, we review how to increase reproducibility and transparency of RWE studies in rare diseases through disease-specific FDNs.

Haematology Outcomes Network in Europe (HONEUR)-A collaborative, interdisciplinary platform to harness the potential of real-world data in hematology.

Introduction: There remains a need to optimize treatments and improve outcomes among patients with hematologic malignancies. The timely synthesis and analysis of real-world data could play a key role.

Objectives: The Haematology Outcomes Network in Europe (HONEUR) is a federated data network (FDN) that aims to overcome the challenges of heterogenous data collected from different registries, hospitals, and other databases in different countries.

The Value of Federated Data Networks in Oncology: What Research Questions Do They Answer? Outcomes From a Systematic Literature Review.

Objectives: Real-world evidence (RWE) plays an important role in addressing key research questions of interest to healthcare decision makers. Federated data networks (FDNs) apply novel technology to enable the conduct of RWE studies with multiple partners, without the need to share the individual partner's data set. A systematic review of the published literature was performed to determine which types of research questions can best be addressed through FDNs, specifically in the field of oncology.

Drospirenone plus estradiol and the risk of serious cardiovascular events in postmenopausal women.

Objectives: To compare incidence rates of serious cardiovascular events, particularly arterial thromboembolic events (ATE), in users of hormone replacement therapy (HRT), particularly oral continuous combined preparations.

Methods: Prospective, controlled cohort study with four arms: women using (1) drospirenone (DRSP)/estradiol, (2) other oral continuous combined HRT (HRTcc), (3) all other oral HRTs, and (4) non-oral HRT. The study population consisted of women aged 40+ years in seven European countries who were new users of HRT at the time of inclusion.

Cardiovascular and general safety of a 24-day regimen of drospirenone-containing combined oral contraceptives: final results from the International Active Surveillance Study of Women Taking Oral Contraceptives.

Objectives: The "International Active Surveillance Study of Women Taking Oral Contraceptives" investigated the risks of short- and long-term use of an extended 24-day regimen of drospirenone and ethinylestradiol (DRSP24d) compared to established oral contraceptives (OCs) in a routine clinical setting.

Study Design: Prospective, controlled, noninterventional cohort study conducted in the United States and six European countries with three main cohorts: new users of DRSP24d, DRSP21d (21-day regimens of DRSP-containing OCs), and non-DRSP (OCs without DRSP). All self-reported clinical outcomes of interest (OoI) were validated via attending physicians and relevant source documents.

Levonorgestrel-releasing and copper intrauterine devices and the risk of breast cancer.

Background: This study compares the risk of breast cancer for levonorgestrel-releasing intrauterine devices (LNG(IUD)) versus copper IUDs (CU(IUD)) in women younger than 50 years of age.

Study Design: Retrospective, population-based, case-control study using cancer registers in Finland and Germany, powered to exclude a 1.5-fold risk of breast cancer.

Effectiveness of oral contraceptive pills in a large U.S. cohort comparing progestogen and regimen.

Objective: To estimate real-life effectiveness of oral contraceptive pills by progestogen, length of pill-free interval, and body mass index while focusing on the effect of progestogens with a long half-life and on 24-day oral contraceptive pills regimens.

Methods: Outcome data from 52,218 U.S.

International Active Surveillance Study of Women Taking Oral Contraceptives (INAS-OC Study).

Background: A 24-day regimen of contraceptive doses of drospirenone and ethinylestradiol (DRSP/EE 24d) was recently launched. This regimen has properties which may be beneficial for certain user populations (e.g.