1. Food and Drug Administration (FDA)Adaptive designs for clinical trials of drugs and biologics ‐ guidance for industry;2019.https://www.fda.gov/media/78495/download. Accessed February 06 2020.
2. Food and Drug Administration (FDA)Guidance for industry and food and drug administration staff: adaptive designs for medical device clinical studies;2016.https://www.fda.gov/downloads/medicaldevices/deviceregulationandguidance/guidancedocuments/ucm446729.pdf. Accessed February 06 2020.
3. European Medicines Agency (EMA)Reflection paper on methodological issues in confirmatory clinical trials planned with an adaptive design;2007.https://www.ema.europa.eu/en/methodological‐issues‐confirmatory‐clinical‐trials‐planned‐adaptive‐design. Accessed February 06 2020.
4. Blinded continuous monitoring of nuisance parameters in clinical trials
5. Blinded continuous monitoring in clinical trials with recurrent event endpoints