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

Challenges and Opportunities?

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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.

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Table I

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Notes

  1. Pew Research Centre estimates that 73% of US adults have Internet access and, of these, 83% use the Internet for health-related information.

  2. EORTC QLQ-C30: European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire (30 questions).

  3. SF-36: Short Form (QoL questionnaire) — 36 questions.

  4. EuroQoL: EQ5D — standardized health outcome instrument.

  5. QL-index: Spitzer Quality of Life Index.

  6. CTCAE: National Cancer Institutes’ Common Terminology for Adverse Events.

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Acknowledgements

The authors would like to thank Sally Okun from PatientsLikeMe for supplying figure 2 and the accompanying Adverse Event Reporting System data.

No sources of funding were used to assist in the preparation of this review. The authors have no conflicts of interest that are directly relevant to the content of this review, but are currently chairing and convening a not-for-profit Patient Reported Outcomes in Safety Event Reporting (PROSPER) consortium between industry, regulators, prescribers, academics and patients to develop tangible guidelines in this area. Interested parties are requested to contact Dr Banerjee directly at the correspondence address to obtain further details of the PROSPER consortium.

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Authors and Affiliations

  1. Pope Woodhead & Associates, The Old Grammar School, 1 Ramsay Road, St Ives, Cambridgeshire, PE27 5BZ, UK

    Anjan Kumar Banerjee (Deputy Managing Director) & Simon Ingate

  2. Institute of Biotechnology, University of Cambridge, Cambridge, UK

    Anjan Kumar Banerjee (Deputy Managing Director)

  3. Department of Surgery, ULH NHS Trust, Lincoln, UK

    Anjan Kumar Banerjee (Deputy Managing Director)

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  1. Anjan Kumar Banerjee
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Correspondence to Anjan Kumar Banerjee.

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Banerjee, A.K., Ingate, S. Web-Based Patient-Reported Outcomes in Drug Safety and Risk Management. Drug Saf 35, 437–446 (2012). https://doi.org/10.2165/11632390-000000000-00000

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