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Best Practices in Long-Term Safety Follow-Up Studies in Oncology


As the quest to develop more effective treatments for cancer continues, a growing number of therapies are receiving accelerated approval. Accelerated approval often comes with a commitment for post-approval safety follow-up studies that can extend for many years, and for some treatments, decades.


Such long study periods pose challenges for sponsors and contract research organizations (CROs) in minimizing patient attrition and data loss. At the same time, sponsors and CROs must develop cost-effective approaches to these studies so that they are sustainable and produce regulator-grade data.


In this article, learn more about how the demands of long-term follow-up studies of oncology therapies are changing and recommendations for keeping sites and patients engaged in ongoing research.

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