In 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. | |
14 Citations | Finally, we make the case that randomized phase II trials are feasible, as long as reasonable statistical standards are applied. |
| In our opinion, phase II randomized screening trials, when properly applied, can assure optimal use of limited phase III financial and patient resources. | |
55 Citations | Randomized phase II/III trials use an adaptive trial design that combines these two types of trials in one, with potential gains in time and reduced numbers of patients required to be treated. |
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. |
| This has implications for patients' planning on participating in phase I clinical trials. | |
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. |
19 Citations | Randomized controlled trials are a true experiment in clinical practice and provide the most valid answers to clinical questions by reducing bias originating from patients, providers, and investigators. |
Related Questions
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What are the advantages and disadvantages of randomized control trials?4 answersRandomized controlled trials (RCTs) have several advantages. They are considered the gold standard in research design, as they minimize confounding factors that may influence results. RCTs provide the best evidence for the effectiveness of a new treatment. They are used in various disciplines, including medicine, vaccine trials, and behavioral economics. RCTs also serve as a basis for drug regulation and national guideline development. However, RCTs also have limitations. They can be challenging to design and conduct, time-consuming, and expensive. Small or underpowered trials may have limitations such as selection bias, inability to discriminate uncommon outcomes, and imprecision of point estimates. It is important to critically appraise the trial design and results, and consider the limitations when interpreting RCT findings.
What is the randomized control trials?5 answersRandomized controlled trials (RCTs) are the preferred study design for assessing efficacy in clinical trials. RCTs involve randomly allocating participants to different treatment groups to compare the effects of different interventions. The random allocation of treatments helps to minimize bias and ensure that the groups being compared are similar in terms of baseline characteristics. Different methods of randomization, such as simple randomization, random permuted blocks, stratification, minimization, and outcome-adaptive randomization, can be used depending on the specific trial design and objectives. RCTs are commonly used to evaluate the causal effect of a treatment on a health outcome of interest in a patient population. When appropriately designed and conducted, RCTs can produce robust evidence for the safety and efficacy of health or medical interventions. The results of RCTs provide important guidance for clinical practice and can contribute to the development of clinical practice guidelines. However, there may be circumstances when RCTs are not feasible, and in such cases, observational data can be considered, but with careful consideration of the criteria for its application.
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