Advances in proton therapy have garnered much attention and speculation in recent years as the indications for proton therapy have grown beyond pediatric, prostate, spine, and ocular tumors. To achieve and maintain consistent access to this cancer treatment and to ensure the future viability and availability of proton centers in the United States, a call for evidence has been heard and answered by proton radiation oncologists. Answers provided in this review include the evolution of proton therapy research, rationale for proton clinical trial design, challenges in and barriers to the conduct of proton therapy research, and other unique considerations for the study of proton therapy.

近年来，质子治疗的进展引起了广泛关注和猜测，因为质子治疗的适应症已经超出了儿科、前列腺、脊柱和眼部肿瘤的范围。为了实现并保持这种癌症治疗的持续可及性，并确保美国质子中心未来的生存能力和可用性，质子放射肿瘤学家已经听到并回应了对证据的呼吁。本综述提供的答案包括质子治疗研究的演变、质子临床试验设计的基本原理、质子治疗研究进行的挑战和障碍，以及质子治疗研究的其他独特考虑因素。