The Medical Imaging & Technology Alliance Conference on Research Endpoints Appropriate for Medicare Coverage of New PET Radiopharmaceuticals

Journal of Nuclear Medicine

Bruce J. Hillman¹  Richard A. Frank¹  Brian C. Abraham¹ 

关键词: PET;    National Oncologic PET Registry;    regulation;    payment;    clinical trial endpoints;    diagnostic endpoints;   

DOI  :  10.2967/jnumed.113.127886

学科分类：医学（综合）

来源: Society of Nuclear Medicine

【 摘 要 】

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.

【 授权许可】

Unknown