RESEARCH TRIANGLE PARK, NC--(Marketwired - November 09, 2016) - Individual case safety reports (ICRs), global safety databases and external literature are the top sources of drug safety information that 80% of pharmaceutical companies use, according to a recent study published by Cutting Edge.
In addition to those resources, 67% of drug safety teams also use lab data, which encompass company-sponsored clinical and preclinical research. However, more than half (53%) of all surveyed teams leverage investigator-initiated trial (IIT) results, the study found.
According to Pharmacovigilance: Balance Signal Detection and Case Management Responsibilities with Emerging Drug Safety Regulation, global drug safety and pharmacovigilance teams more often use all of these resources to obtain the data they need. The largest percentage of both global groups and country-level teams look to ICRs and global safety databases, 82% versus 75% of surveyed groups, respectively. Surprisingly, even though 73% of global teams analyze external literature to identify drug safety information, no country-level teams utilize these resources. However, since global teams take on this responsibility, country-level groups may find it redundant.
"Companies are responsible for determining the necessary drug safety information that they need to share with internal and external stakeholders," said Sarah Ray, senior research analyst at Cutting Edge Information. "This is the basis for pharmacovigilance affairs and can support an array of activities; anything from preparing regulatory submissions to supporting and developing risk management strategies. The resources and tools that these groups use are not limited to databases and safety reports."
Pharmacovigilance groups have a wide range of responsibilities which support both investigational and marketed products. Drug safety initiatives often start very early on in the lifecycle, sometimes even in the preclinical development stage. This premature start allows firms to compose more thorough drug safety profiles, improve signal detection thresholds and create the best-fit risk management plans.
Pharmacovigilance: Balance Signal Detection and Case Management Responsibilities with Emerging Drug Safety Regulations, available at http://www.cuttingedgeinfo.com/research/clinical-development/driving-pharmacovigilance-success/, uncovers best practices and benchmarks associated with drug safety. The report's data were compiled from global and country-level teams for large and small pharma and biotech companies, as well as medical device companies. The report is designed to help drug safety executives in the following ways:
- Explore companies' case management approaches and gain top executives' recommendations concerning for improving existing case management procedures.
- Develop structures that best align with their needs—as determined by the number of products within their pipeline and the relative complexity of these products.
- Determine what percentage of drug safety funding should come from different groups within a life sciences organization.
- Determine best-fit budget allocations to different pharmacovigilance activities.
- Identify the percentage of costs teams should outsource for different drug safety activities.
For more information about Cutting Edge Information and its drug safety benchmarking data, visit www.cuttingedgeinfo.com.
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