Asian Development Bank, Mandaluyong City 1550, Philippines.
Eur J Health Econ. 2013 Apr;14(2):323-44. doi: 10.1007/s10198-012-0379-6.
An important health policy issue is the low rate of patient enrollment into clinical trials, which may slow down the process of clinical trials and discourage their supply, leading to delays in innovative life-saving drug treatments reaching the general population. In the US, patients' cost of participating in a clinical trial is considered to be a major barrier to patient enrollment. In order to reduce this barrier, some states in the US have implemented policies requiring health insurers to cover routine care costs for patients enrolled in clinical trials. This paper evaluates empirically how effective these policies were in increasing the supply of clinical trials and speeding up their completion, using data on cancer clinical trials initiated in the US between 2001 and 2007. Our analysis indicates that the policies did not lead to an increased supply in the number of clinical trials conducted in mandate states compared to non-mandate states. However, we find some evidence that once clinical trials are initiated, they are more likely to finish their patient recruitment in a timely manner in mandate states than in non-mandate states. As a result, the overall length to completion was significantly shorter in mandate states than in non-mandate states for cancer clinical trials in certain phases. The findings hint at the possibility that these policies might encourage drug innovation in the long run.
一个重要的健康政策问题是患者参与临床试验的比率较低，这可能会减缓临床试验的进程，并阻碍其供应，导致创新的救命药物治疗延迟普及到普通人群。在美国，患者参与临床试验的成本被认为是阻碍患者参与的主要因素。为了降低这一障碍，美国的一些州已经实施了政策，要求健康保险公司为参与临床试验的患者支付常规护理费用。本文利用美国 2001 年至 2007 年间启动的癌症临床试验数据，从经验上评估了这些政策在增加临床试验供应和加快完成速度方面的有效性。我们的分析表明，与非授权州相比，授权州的临床试验数量并没有因这些政策而增加。然而，我们发现了一些证据表明，一旦临床试验开始，在授权州完成患者招募的速度比在非授权州更快。因此，对于某些阶段的癌症临床试验，授权州的总体完成时间明显短于非授权州。这些发现表明，这些政策从长远来看可能会鼓励药物创新。
