Web-Based Patient-Reported Outcomes in Drug Safety and Risk Management

Abstract

Patient-reported outcomes (PROs) from web-based sources are becoming increasingly important, providing opportunities for industry and regulators to understand the benefits and risks of medicines in a real-world context. Although some guidance exists for the use of adverse event (AE) reports from company-sponsored social network sites, this does not cover non-company-sponsored sites. Additionally, there are concerns about the validity of data from social media sources. Techniques for the collection, analysis and reporting of safety data from patients should be defined, and guidelines agreed, to cover PROs and patient-reported adverse drug-related events from more organized sources of patient outcomes. This review considers drivers for web-based PRO adoption in drug safety, the current regulatory framework and potential methodologies, and concludes that there is an urgent unmet need for guidelines on web-based PRO AEs. Stakeholders for the development of any such guidance should include industry, patients, regulators, academic groups and prescribers.

Quality of Life in Organ Transplant Recipients Participating in an Online Transplant Community

“…PROs are gaining increasing prominence as useful tools in the measurement of medicine, for instance in detecting important outcomes such as fatigue in cancer [17], the detection of adverse events for marketed drugs [18], risk management programs for drugs with a high risk profile [19], and non-primary endpoints in the labels of newly approved drugs [20]. However, methodological limitations of PROs remain, such as unblinding, dealing with missing data, and cross-cultural validation of instruments.…”

How pharmacy's adoption of social media can enhance patient outcomes

“…42,43 A study of a Facebook group set up to capture drug adverse events showed that this approach is feasible, and several of the events were considered to be drug-related. 44 However, regulating these channels would require careful consideration and significant resources.…”

Translational Informatics in Personalized Medicine: An Update for 2014

“…Outside of formal clinical trials, PROs are being used to build significant bodies of data on the daily impacts of chronic degenerative diseases such as Parkinson's disease [25]. In addition, PROs are being studied for utility in the medical safety surveillance of drugs and, despite some debate regarding the quality of these measures when collected online versus those collected via traditional means, there is an urgent need to enable online reporting of medical adverse events [26].…”