Observational & Pragmatic Research Institute (OPRI)

This sponsor has funded 10 studies across 33 countries.

PAS funded by this sponsor.
EU PAS ID Status RMP requirement Title Protocol uploaded Results uploaded
31405 Planned Not included in RMP A pragmatic, cluster randomized trial evaluating the impact of an enhanced adherence package (dual bronchodilator+add-on+app) on time to treatment... No No
32899 Ongoing Not included in RMP Severe Asthma Super-Responders Delphi Exercise No No
38199 Planned Not included in RMP Addressing the burden of respiratory disease in General Practice: A real-life implementation study focusing on high risk asthma and COPD patients No No
43721 Finalised Not included in RMP Twenty years of COPD primary care: Patterns of management of high-risk COPD and opportunities for optimising care in the United Kingdom 2000-2019:... Yes No
49548 Planned Not included in RMP Biologic Usage Patterns, Clinical Outcomes and Healthcare Resource Utilization (CLEAR) No No
104132 Planned Not included in RMP Exploring different composite definitions of responders and non-responders to biologic treatment for severe asthma (FULL BEAM) No No
104139 Planned Not included in RMP Impact of biologic initiation on steroid burden and new-onset of potentially OCS-related outcomes in patients with severe asthma (SOLAR) No No
105737 Planned Not included in RMP Exacerbation history in COPD patients prior to diagnosis and subsequent treatment and outcomes No No
105920 Planned Not included in RMP Redefining severe asthma to high-risk asthma: Analysis of real-world data to investigate patients who are at high risk of exacerbations, worsening of... No No
106491 Planned Not included in RMP Patient characteristics and treatment pathways in patients with COPD initiated on ICS/LABA/LAMA and LABA/LAMA treatment No No

PAS by Risk Management Plan (RMP) requirement

Observational & Pragmatic Research Institute (OPRI)

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.