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首页> 外文期刊>Contemporary clinical trials >How many tumor indications should be initially screened in development of next generation immunotherapies?
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How many tumor indications should be initially screened in development of next generation immunotherapies?

机译：在下一代免疫治疗的开发中，最初应筛选多少肿瘤适应症？

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An experimental oncology immunotherapy may have the potential to be effective in a large number of tumor indications. We have considered a staggered approach for efficacy screening in subjects with an unmet medical need. A cohort of tumor indications is selected for the first wave investigation and the second wave investigation in a different cohort of tumor indications is initiated only after the drug has been demonstrated to be effective in the first wave. The effectiveness of an experimental immunotherapy is unknown at the planning stage, and the assumptions at the planning stage are subject to revision later on. How many tumor indications should be investigated in the first wave for the development program to be cost-effective amid the uncertainties? We attempt to answer this question by maximizing a benefit-cost ratio, defined to be the expected number of effective tumor indications correctly identified in the two waves (benefit) divided by the expected total sample size in the two waves and the subsequent trials for more definitive testing triggered by those with a positive outcome in the first wave (cost). It is found from the benefit-cost ratio analyses that, depending on resource availability, three to five tumor indications may be initiated in the first wave to properly balance the risk and benefit, and adequate investment is important to maintain the quality of statistical design.
机译：实验性肿瘤学免疫疗法可能有可能在大量肿瘤适应症中有效。我们考虑了具有未满足医疗需求的受试者有效筛查的交错方法。选择肿瘤适应症的群体适用于第一波查调查，并且仅在药物证明在第一波中有效后，仅启动不同肿瘤指示中的第二波查。实验免疫疗法的有效性在规划阶段未知，规划阶段的假设稍后会进行修订。在不确定因素中，在发展方案的第一波中应调查有多少肿瘤适应症，以在不确定性中具有成本效益？我们试图通过最大限度地提高益处成本比，定义为在两波（益处）中正确鉴定的有效肿瘤指示的预期数量（益处）除以两波浪中的预期总样本，以及随后的试验，以便更多的预期肿瘤指示在第一波（成本）中具有正结果的人触发的确定性测试。从益处成本比分析中发现，根据资源可用性，在第一波中可以启动三到五个肿瘤指示，以适当地平衡风险和利益，并且适当的投资对于保持统计设计的质量是重要的。

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