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Randomized clinical trials have long been held up as the “gold standard” for drug development. With a properly designed and conducted randomized trial, observed differences in efficacy and safety outcomes can be reliably attributed to the investigational drug. However, randomized clinical trials may not be practical under certain circumstances. While applicable, the studies may be designed with external control, wherein outcomes of participants in a treatment group are compared to outcomes among an external group of people who are not in the same trial. These data may come from participants in a different trial or real-world data from patients receiving routine medical care. With externally controlled clinical trials, confidence in the attributions to the treatment of interest is diminished because of potential bias and concerns over imbalances between the treatment group and the external control group. These concerns are more likely to arise when the data in the external control group are from a real world data source than when the data come from another clinical trial with a protocol-based design that includes criteria for administering treatment and regular follow-up, and it could be challenging to establish the validity of the results where the difference of the outcomes observed between groups can be attributed to factors other than the treatment of interest. In such clinical trials with external control, careful considerations need to be taken to reduce the potential for bias in the design and analysis phases. In this talk, the presenter will discuss the Agency’s considerations in design and analysis in oncology and hematology clinical trials with external control. Regulatory review examples will also be discussed in the presentation.