National Institutes of Health (NIH)
This sponsor has funded 5 studies across 3 countries.
| EU PAS ID | Status | Title | Protocol uploaded | Results uploaded |
|---|---|---|---|---|
| 31539 | Finalised | Newer glucose-lowering agents versus thiazolidinediones on risk of incident cirrhosis and clinical decompensation events in patients with diabetes... | Yes | Yes |
| 32010 | Ongoing | Is Intravenous Bisphosphonate Use Associated with a Higher Risk of a Flare in Inflammatory Bowel Disease Patients? (Bisphosphonates and IBD Flare... | Yes | No |
| 37902 | Ongoing | Prevalence and patterns of medication deintensification following severe hypoglycemia among older adults with diabetes | No | No |
| 43551 | Ongoing | Large-scale evidence generation and evaluation across a network of databases for type 2 diabetes mellitus (LEGEND-T2DM) | Yes | No |
| 48616 | Ongoing | Bayesian Evaluation of Time-To-Event and Reliability (for vaccine surveillance) (BETTER) | Yes | No |
PAS by Risk Management Plan (RMP) requirement
National Institutes of Health (NIH)
The RMP for a medical product outlines strategies to identify, assess, and mitigate risks, including PAS for further evaluation.
Category 1 studies are imposed as condition of marketing authorisation.
Category 2 studies are imposed as specific obligation of marketing authorisation.
Category 3 studies are required under other circumstances.
PAS by study status
National Institutes of Health (NIH)
The study status is defined according to the timeline dates specified.
Planned studies have not collected any data yet.
Ongoing studies collect data and should publish protocols as soon as possible.
Finalised studies should publish results in the first two weeks after finalisation.
Countries
National Institutes of Health (NIH)
3 Study countries specified are the following:
- Spain
- United Kingdom (Northern Ireland)
- United States