Wimmer Neil J, Robbins Susan, Ssemaganda Henry, Yang Erin, Normand Sharon-Lise, Matheny Michael E, Herz Naomi, Rising Josh, Resnic Frederic S
Christiana Care, Division of Cardiology, Newark, DE, USA.
Comparative Effectiveness Research Institute and Department of Cardiovascular Medicine, Lahey Clinic Foundation, Burlington, MA, USA.
J Health Care Finance. 2016 Summer;2016(Spec Features).
Approved medical devices frequently undergo FDA mandated post-approval studies (PAS). However, there is uncertainty as to the value of PAS in assessing the safety of medical devices and the cost of these studies to the healthcare system is unknown. Since PAS costs are funded through device manufacturers who do not share the costs with regulators, we sought to estimate the total PAS costs through interviews with a panel of experts in medical device clinical trial design in order to design a general cost model for PAS which was then applied to the FDA PAS. A total of 277 PAS were initiated between 3/1/05 through 6/30/13 and demonstrated a median cost of $2.16 million per study and an overall cost of $1.22 billion over the 8.25 years of study. While these costs are funded through manufacturers, the ultimate cost is borne by the healthcare system through the medical device costs. Given concerns regarding the informational value of PAS, the resources used to support mandated PAS may be better allocated to other approaches to assure safety.
获批的医疗设备经常要接受美国食品药品监督管理局（FDA）规定的批准后研究（PAS）。然而，PAS在评估医疗设备安全性方面的价值存在不确定性，而且这些研究对医疗保健系统的成本尚不清楚。由于PAS的费用由设备制造商承担，而制造商并不与监管机构分担成本，我们试图通过采访一组医疗设备临床试验设计专家来估算PAS的总成本，以便设计一个PAS的通用成本模型，然后将其应用于FDA的PAS。在2005年3月1日至2013年6月30日期间，共启动了277项PAS，每项研究的中位数成本为216万美元，在8.25年的研究期间总成本为12.2亿美元。虽然这些成本由制造商承担，但最终成本由医疗保健系统通过医疗设备成本来承担。鉴于对PAS信息价值的担忧，用于支持规定的PAS的资源可能更好地分配到其他确保安全的方法上。
