Pharmacoepidemiologic General Research eXtension (PGRx)

Real world datasets for multiple purposes

No. 1 datasets for continuous benefit-risk assessment now available for HEOR studies & performance assessment

First developed for the study of the safety and risk of medicines, PGRx datasets were rapidly applied to the study of the comparative effectiveness of drugs in the prevention of morbidity and mortality outcomes. They now also incorporate information of special interest for health economics and payers’ decision purposes.

Case-based data for risk & effectiveness assessment

PGRx datasets allow in-depth analysis and regulatory-grade studies, as part of RMP, REMS, Continuous Benefit/Risk assessment, Post-Authorisation Safety Studies (PASS), Post-Authorisation Efficacy Studies (PAES), Coverage with Evidence Development (CED) or rapid response to alerts. PGRx data were used for pioneer continuous benefit-risk assessments and are the No1 primary data collections cited for that purpose on the ENCePP site.

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New data for HEOR studies and decisions

Data collected by PGRx also provides in-depth information for the study of treatment pathways, clinical decisions, and patient journeys useful in predictive modeling, bridging studies, population impact assessment, cost-effectiveness studies, budget impact and other economic appraisals. PGRx data were used for pioneer outcome- based performance plans and provide a unique opportunity to expedite market access

Both medical & patient data

The only datasets to offer a possibility of follow-up and linkage

Using standardised data collection tools that have been validated in multiple studies, the PGRx Observation System offers a unique opportunity for obtaining extremely high quality data in real time, combining both medical information and patient reported outcomes

Medical Information

Data are collected from medical records and/or directly from physicians, providing detailed information on diagnoses and associated subconditions, laboratory tests, imaging and other diagnostic procedures, medication use and other healthcare resources.
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Patient Voice

A unique feature of PGRx data is that a linked subsample of patients are surveyed directly through autoquestionnaires or interviews on their drug use, adherence to treatment, including OTC drug use, personal history, risk factors, quality of life and outcomes. Patient consent allows follow-up and linkage to electronic records from other sources.

5 of the top 8 major pharma manufacturers and 15 mid-size companies and biotechs already use PGRx

Datasets in multiple therapy areas

PGRx licenses data from our networks of centers across Europe and North America, maintaining data collection in multiple therapy areas. More than 20 disorders are presently available in PGRx, from a dozen therapy areas. The list is constantly up-dated and increased in response to need.

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The PGRx deliverables

With PGRx Real World Datasets we commit to deliver:

  • Fast, real time data: the PGRx System provides data in a few weeks on almost any disorder or clinical sub-population, thereby allowing rapid responses to any information need
  • Credible data: PGRx provides high specificity of disease diagnosis and uses only validated questionnaires on patient reported outcomes and drug use
  • Ethical data: PGRx data collection being approved by ethics committees, and samples collected in respect of epidemiological principles, the data can be used for peer-review publications and reports to health authorities 
  • Powerful data: because only cases of interest are collected, and with a high positive predictive value on all parameters considered, the PGRx datasets are as powerful as very large databases or surveys that eventually provide only a few really relevant sets of data.
  • Efficient data: the costs of PGRx data is fixed and includes all expenses and fees, including investigators’ fees. The multiple users of the system, and sometimes of the same data, allows very significant savings.

*The PGRx trade name belongs to Lucien Abenhaim and Lamiae Grimaldi. The use of the systematic case-referent methodology is on free access.