Nutritional and Metabolic Diseases

Gland and Hormone Related Diseases

All Conditions

Diseases and Abnormalities at or Before Birth

Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Symptoms and General Pathology

Diabetes Mellitus

Congenital Abnormalities

Polycystic Ovary Syndrome

Abortion, Spontaneous

Syndrome

Cysts

Ovarian Cysts

Ovarian Diseases

Adnexal Diseases

Genital Diseases, Female

Genital Diseases

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Gonadal Disorders

Endocrine System Diseases

Hypoglycemic Agents

All Drugs and Chemicals

Metformin

Insulin

Insulin, Globin Zinc

Pregnant women seeking counseling by themselves or through their healthcare provider for exposure to metformin (Anatomical Therapeutic Chemical A10BA02) any time during pregnancy (i. e. any time from conception to week 42 after last menstrual period (LMP)).

Pregnant women seeking counseling by themselves or through their healthcare provider for exposure to any drug not known as a major teratogen or fetotoxicant and different than metformin, insulin or any other hypoglycaemic agent.

This is not an intervention but an observed exposure.

metformin

any drug not known as a major teratogen or major fetotoxicant

This study aims to better characterize the risk linked to metformin use during pregnancy, using a prospective multicentric cohort design enabling a large sample size, in evaluating the rate of birth defects after first trimester exposure, as well as several other pregnancy related outcomes.

Safety of Metformin in Pregnancy

Pregnancy Outcome Following Maternal Exposure to Metformin: a Collaborative ENTIS Study

Centre Hospitalier Universitaire Vaudois

Senior research associate

Respiratory Tract (Lung and Bronchial) Diseases

Carcinoma, Non-Small-Cell Lung

Lung Neoplasms

Carcinoma

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

Carcinoma, Bronchogenic

Bronchial Neoplasms

Antineoplastic Agents

Micronutrients

Hematinics

Vitamins

Pembrolizumab

Pemetrexed

Antineoplastic Agents, Immunological

Immune Checkpoint Inhibitors

Enzyme Inhibitors

Folic Acid

Vitamin B Complex

Folic Acid Antagonists

Folinic Acid

Folate

Vitamin B9

Medication records in EHR database used to define exposure group

Pembrolizumab + Pemetrexed-Platinum

Medication records in EHR database used to define comparator group

Pemetrexed-Platinum

David Merola, PharmD, PhD

Investigators are building an empirical evidence base supporting the utility of real-world data through the emulation of randomized controlled trials in the oncology setting. The purpose of this work is to demonstrate whether real-world evidence studies can provide reliable conclusions on treatment effectiveness to inform further applications of real-world data in pharmaceutical product label expansion, post-marketing safety, and other purposes that are complementary to RCTs.

This is a non-randomized observational study that is being conducted as a part of the Coalition to Advance Real-World Evidence through Randomized Controlled Trial Emulation (CARE) Initiative, a multi-stakeholder collaboration led by Aetion. The study is intended to emulate the trial listed below/above. Although many features of the trial cannot be directly replicated in real-world data sources, key elements of the study design, including outcomes, exposures, and inclusion/exclusion criteria, were selected to proxy those features from the trial as closely as possible. Investigators assume that the trial provides the reference standard treatment effect estimate and that failure to replicate trial findings is indicative of the inadequacy of the real-world data source for replication for a range of possible reasons and does not provide information on the validity of the original trial finding.

Emulation of the KEYNOTE-189 Trial Using Electronic Health Records

Emulation of a Comparative Effectiveness Study of Pembrolizumab and Chemotherapy vs. Chemotherapy for the First-line Treatment of Metastatic Non-small Cell Lung Cancer

Data analysis code and de-identified patient-level data files may be made available, provided that it is determined that this will not violate the investigators' data usage agreements and patient privacy requirements.

Relative hazard of mortality due to any cause

Aetion, Inc.

Principal Scientist

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Safety of Metformin in Pregnancy	NCT02793505	Pregnancy Pregestational ... Polycystic Ovar...	metformin any drug not kn...	-	Centre Hospitalier Universitaire Vaudois
Emulation of the KEYNOTE-189 Trial Using Electronic Health Records	NCT05908799	Non-small Cell ... Metastatic Lung...	Pembrolizumab +... Pemetrexed-Plat...	-	Aetion, Inc.

Spots Global Cancer Trial Database for pharmacoepidemiology