… would: 1) reap enough returns to pay for their own development … understanding why so few
initially promising drugs fail to pass … of phase II trials makes it difficult to identify long-term side …

… in the long term we all … phase II trials to predict long-term survival benefits. Kola and Landis
(52) highlighted that 60% of regimens that had “promising” activity in single-arm phase II trials …

… trials, randomised phase II trials without a control group and randomised phase II trials of
surgery, radiotherapy, life style … II trials, our study showed that promising results from …

… We observe some heterogeneity in rates of return for … on promising approaches to estimating
long-term impacts, both … We provide lessons from our experience in conducting long-term …

… tested in phase II or III pharma efficacy trials for psychiatric … of long-term use in the treatment
of major mental illnesses. … following ketamine infusion, which returned to levels observed on …

… associated with long-term survival 19 . Furthermore, in a … in preclinical mouse models and
finally returned to the clinic in the … Below, we discuss promising approaches to achieve this. …

… In parallel to the decreasing productivity, returns of investments in … examined in phase II. This
may also lead to more efficient … Long-term trials do not only require costly investments. More …

… We compared randomized and non-randomized phase II designs while holding sample size
… that randomized trials are necessarily larger. The non-randomized single-arm trial allocates …

… optimization trials to return some … promising path forward for postapproval dose optimization,
25,63 drugmakers need to see how dose optimization can be consistent with long-term …

… insulin after 12 weeks, with return to baseline after 49 weeks. … tumor No In second Phase
II trial, ifosfamide dose increased to … The study will be designed to demonstrate the long-term …