How many people selected Phase 2 clinical trials?
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157 Citations | We propose a methodology for conducting phase II clinical trials in settings where the disease is categorized into multiple subtypes. |
Few randomized clinical trials have been conducted. | |
This study shows that a selected group of clinical trials, some of which were controversial and expensive, were indeed a good investment. | |
Third, outcome measures used in future phase 2 and phase 3 trials should be highly sensitive and be accompanied by smart trial designs. | |
Both phase 0 and phase II NF2 trials are near-term options for NF2 clinical trials. | |
37 Citations | Findings from small pilot studies suggest that phase II and III clinical trials result in at most modest increases in cost over standard treatment costs. |
This has implications for patients' planning on participating in phase I clinical trials. | |
Clinical trial simulation can improve decisions made in learning Phase I and Phase II studies, leading to better designs and reduced chance of failure in high-cost, confirmatory Phase III trials. | |
As the main cost drivers in these phase II clinical trials are laboratory and imaging tests, the cost of clinical trials could potentially be reduced by ensuring that only essential tests are required by protocol. | |
#### Summary points Clinical trials should be registered so that essential details are made public from a trial's inception, rather than from publication many years later Openness about trials in progress reduces the … | |
43 Citations | These methods are useful for designing stratified phase II clinical trials. |
The observations that many new therapeutics “fail” in definitive phase III studies, coupled with the numbers of new agents to be tested as well as the increasing costs and complexity of clinical trials, further emphasize the critical importance of robust and efficient phase II design. | |
However, the lack of reproducibility is more likely due to small sample sizes for phase I trials and differences between patients enrolled on phase I trials and those enrolled on phase II and II trials. | |
72 Citations | As a result, accurately informed patients may reasonably decide to enroll in phase 1 oncology trials in hopes of obtaining benefit, after considering the anticipated risks and available clinical alternatives. |
We develop the method in the context of phase II oncology trials, but the method applies readily to other clinical areas in which multiple responses per patient are of interest. |
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