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Frequently Asked Questions

When clinical trials enter phase III, they have already demonstrated considerable safety and efficacy. The drug in question has been scrutinized for years and has been overseen by regulatory bodies such as the US Food and Drug Administration (FDA) and institutional review boards (IRBs), groups that monitor and review biomedical research involving human subjects.1

References

  1. FDA. The drug development process: step 3. Updated January 4, 2018. Accessed September 11, 2025. https://www.fda.gov/patients/drug-development-process/step-3-clinical-research
  2. Unger JM, Shulman LN, Facktor MA, et al. National estimates of the participation of patients with cancer in clinical research studies based on Commission on Cancer accreditation data. J Clin Oncol. 2024;42(18):2139-2148. doi:10.1200/JCO.23.01030
  3. FDA. Integrating randomized controlled trials for drug and biological products into routine clinical practice: guidance for industry. Published September 2024. Accessed September 11, 2025. https://www.fda.gov/media/181871/download