Sources of data for PV analytics
Following is a non-exhaustive list of sources of data and information to be used in the framework of PV analytics.
Adverse event (AE) / adverse drug reaction (ADR) case reports
- Company reports of AEs / ADRs generated during the entire life cycle of the medicinal product, which includes clinical development and post-market.
- Health Agency databases: FAERS, EudraVigilance, Vigibase.
Studies
- Nonclinical studies
- Clinical trials, including research in unapproved populations or indications
- Observational studies, real world data, registries
- Systematic reviews and meta-analyses
- Outcomes research studies
- Comparative effectiveness research
- Comparative safety research
- Health economics analyses
Scientific literature
- Published scientific literature or reports from abstracts, including information presented at scientific meetings
- Unpublished manuscripts
Active surveillance systems
- Sentinel systems or sentinel sites
Market access – market research
- Product usage data and drug use information
- Patient support programs
Healthcare – related data
- Administrative and claims data from health insurers
- Clinical data, including vital signs and laboratory test results
- Electronic health records, electronic medical records
- Hospital data
- Medicare data
Internet
- Marketing authorization holder-sponsored websites
- Internet search engines
- Patient forums
- Social media channels
Other
- Information arising from licensing partners, other sponsors, or academic institutions / research networks
- Product quality investigations
- Information from regulatory authorities
- Information obtained from wearables
- Ad-hoc reports generated by company field teams, and medical requests of information regarding potential benefits or risks