Department of Radiology and Medical Imaging, University of Virginia, Charlottesville, Virginia, USA.
J Nucl Med. 2013 Sep;54(9):1675-9. doi: 10.2967/jnumed.113.127886. Epub 2013 Aug 1.
The outcomes of a 2011 Medical Imaging & Technology Alliance (MITA) conference helped shape considerations about what might be the most appropriate pathways for the regulatory and payment considerations of new PET radiopharmaceuticals. As follow-up to that conference, MITA convened a second conference of stakeholders to advise payers on what might be acceptable endpoints for clinical trials to support the coverage of novel PET agents. The conference involved experts on imaging and clinical research, providers of PET services, as well as representatives of interested medical societies, the PET industry, and the regulatory and payer communities. The principal outcome of their deliberations was that it was unrealistic to expect trials of new PET radiopharmaceuticals to directly demonstrate a health benefit. Rather, intermediate outcomes, such as a positive change in patient management, would be more efficient and appropriate.
2011 年医学影像与技术联盟（MITA）大会的成果有助于确定新正电子发射断层扫描放射性药物在监管和支付方面最合适的途径。作为对那次会议的后续行动，MITA 召集了第二次利益攸关方会议，就临床试验的可接受终点向支付方提供咨询意见，以支持新型正电子发射断层扫描药物的覆盖范围。会议涉及影像学和临床研究专家、正电子服务提供商，以及有关医学协会、正电子发射断层扫描行业以及监管和支付方社区的代表。他们审议的主要结果是，期望新的正电子发射断层扫描放射性药物的试验能直接证明对健康有益是不现实的。相反，如患者管理的积极变化等中间结果将更有效和更合适。
