Introduction Technology is emerging as a solution to develop home-based, proactive 'real-
time'symptom monitoring and management in cancer care. The Advanced Symptom …

Real‐world data (RWD) reflecting patient treatment in routine clinical practice can be used to
develop external control groups for single‐arm trials. External controls can provide valuable …

Acute myeloid leukemia (AML) is a markedly heterogeneous hematological malignancy that
is most commonly seen in elderly adults. The response to current therapies to AML is quite …

Historically, phase II trials in oncology were generally single armed, constructed to
distinguish between a tumor response rate felt to indicate a lack of promise (often 5%) and a …

In phase II single‐arm studies, the response rate of the experimental treatment is typically
compared with a fixed target value that should ideally represent the true response rate for …

The exploratory nature of phase II trials makes it quite common to include heterogeneous
patient subgroups with different prognoses in the same trial. Incorporating such patient …

There is a growing need to evaluate of multiple competing drugs in phase II trials where the
number of patients is often limited, and simultaneous assessment of both efficacy and …

Randomized Phase II oncology trial endpoints for decision making include both progression-
free survival (PFS) and change in tumor burden as measured by the sum of longest …

Phase II clinical trials designed for evaluating a drug's treatment effect can be either single‐
arm or double‐arm. A single‐arm design tests the null hypothesis that the response rate of a …

Background A minority of phase III trials in gastrointestinal oncology are positive. We
assessed the association between their outcome and the level and characteristics of …