Which phase do randomized clinical trials take place?
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| Papers (10) | Insight |
|---|---|
8 Citations | Randomized phase II clinical trials can be an efficient means of evaluating several potential new treatments prior to a comparative phase III clinical trial. |
| Without question, randomized phase III trials are required at this time to define what is to be considered optimal treatment. | |
Open access 01 Jul 1993 11 Citations | Randomized clinical trials would gain from incorporating a concern for timing as well as dosing in all three stages of clinical trials (Phase I, II and III focusing on toxicity, efficacy and a comparison with the current best treatment, respectively) and could be cost-effectively preceded by 'Phase 0' trials so as to detect, sooner and with smaller sample sizes, desired or undesired effects that may otherwise be missed. |
77 Citations | The author concludes that the randomized play-the-winner rule is appropriate for some clinical trials, but intense and thoughtful planning must take place in the design phase. |
| In our opinion, phase II randomized screening trials, when properly applied, can assure optimal use of limited phase III financial and patient resources. | |
14 Citations | Finally, we make the case that randomized phase II trials are feasible, as long as reasonable statistical standards are applied. |
| Conversely, new approaches are needed to guide development of drug combinations since both standard phase II approaches and phase II-III randomized trials have a high risk of misleading. SummaryTraditional randomized clinical trials approaches are often inefficient, wasteful, and unreliable. | |
29 Citations | Although traditional phase II cancer trials are usually single arm, with tumor response as endpoint, and phase III trials are randomized and incorporate interim analyses with progression-free survival or other failure time as endpoint, this paper proposes a new approach that seamlessly expands a randomized phase II study of response rate into a randomized phase III study of time to failure. |
43 Citations | These methods are useful for designing stratified phase II clinical trials. |
| These results open a door to sequentially monitor response-adaptive randomized clinical trials in practice. |
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