Abstract

There is significant debate over whether phase 1 pediatric oncology trials are ethical and approvable. We thus surveyed IRB members to answer four questions. First, do IRB members think the potential medical benefits of average phase 1 pediatric oncology trials justify the risks? Second, do they think these trials are ethically appropriate? Third, do they think these trials are approvable? Fourth, how do the views of IRB members on the first two questions compare to the views of the US public? Of the 80 respondents who answered the test questions correctly, 18.8% stated that the potential medical benefits of average phase 1 pediatric oncology trials outweigh the risks, 32.5% stated that the potential medical benefits and risks are about equal, and 48.8% stated that the risks outweigh the potential medical benefits. Compared to the general public, IRB members were significantly more likely to think the risks outweigh the potential medical benefits (p = 0.01). Finally, 68.8% of IRB members indicated that average phase 1 pediatric oncology trials are approvable, and 56.3% indicated that these trials are appropriate in children. These findings suggest two-thirds of IRB members believe average phase 1 pediatric oncology trials are approvable. Yet, almost half regard the risks as outweighing the potential medical benefits and almost half think these trials are inappropriate. These findings raise important questions regarding why IRB members and the general public evaluate the same risk/benefit profile differently, and whether it is possible to reconcile the two perspectives.

 抽象的

关于第一阶段儿科肿瘤学试验是否符合伦理和可批准存在着重大争议。因此，我们对 IRB 成员进行了调查，回答了四个问题。首先，IRB 成员认为平均 1 期儿科肿瘤学试验的潜在医疗益处是否值得承担风险？其次，他们认为这些试验在伦理上是否适当？第三，他们认为这些试验值得批准吗？第四，IRB成员对前两个问题的看法与美国公众的看法相比如何？在正确回答测试问题的 80 名受访者中，18.8% 的人表示平均 1 期儿科肿瘤学试验的潜在医疗效益大于风险，32.5% 的人表示潜在的医疗效益和风险大致相等，48.8% 的人表示风险大于潜在的医疗益处。与公众相比，IRB 成员更有可能认为风险超过潜在的医疗益处 (p = 0.01)。最后，68.8% 的 IRB 成员表示，平均 1 期儿科肿瘤学试验是可以批准的，56.3% 的成员表示这些试验适合儿童。这些发现表明，三分之二的 IRB 成员认为平均 1 期儿科肿瘤试验是可以批准的。然而，几乎一半的人认为风险超过了潜在的医疗益处，几乎一半的人认为这些试验是不合适的。这些发现提出了重要问题，即为什么 IRB 成员和公众对相同的风险/收益状况有不同的评估，以及是否有可能调和这两种观点。