ArticleTrials2026
Platform for the Evaluation of innovations in Radiation oncology through registry-based conduct of multi-centric pragmatic randomized trials: PERa implementation.
Article in Trials, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 7 registered trials, which are not on this map. Not yet cited in PubMed.
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The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Partnership Initiative for the Evaluation of Technological Innovation in Radiotherapy
Focal HDR Brachytherapy Boost to Stereotactic Radiotherapy
Stereotactic Boost and SHOrt-course Radiation Therapy for HPV-associated OroPharynx Cancer Trial: A Randomized Multicentric Phase III Trial
Stereotactic Ablative Radiotherapy for Oligo-Progressive Disease REfractory to Systemic Therapy in Non Small Cell Lung Cancer: A Registry-based Phase II Randomized Trial
Adaptive RadioTherapy for Locally Advanced OroPharynx Cancer (ART-OPC) A Phase II Randomized Trial
Pre-irradiation Vertebroplasty in Patients With Spine Metastases Candidates for SBRT vs SBRT Alone: Increased Early Pain Relief
Ablative Radiotherapy to Consolidate Maximal Systemic Response in Metastatic Prostate Cancer (ANCHOR-Prostate)
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Authors and funding
14 authors.
Funding
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Abstract
purposeRadiotherapy has achieved substantial progress often attributed to accelerated technological innovation over decades. However, randomized controlled trials (RCTs) are costly, difficult to fund and to conduct, such that the generation of quality evidence is outpaced by changes in practice. We sought to evaluate the implementation performance of a platform approach to the conduct of pragmatic RCTs in radiation oncology.
methodsWe implemented PERa, a platform consisting of a prospective registry of patients receiving standard-of-care radiation therapy, designed to support pragmatic registry-based RCT (rRCT) methods and staged informed consent. Implementation performance metrics included rate of registry enrollment, acceptability of re-contact and/or serving as controls for interventional trials, activation and recruitment of embedded comparative effectiveness rRCTs, compliance to study arms, and completeness of ePRO data acquired at scale.
resultsBetween January 1, 2018 and December 31, 2023, the registry accrued 1415 participants across 5 participating institutions. At time of stage 1 consent, 93% agreed to re-contact for participation in a clinical trial, and 97% consented to serve as control. Seven embedded rRCTs were activated, and one third of participants (n = 477) were randomized. Only two study arm non-compliance events were recorded. Although 97% of subjects consented to ePROs, completion rate was only 53% in those with stage 1 only consent, rising to 62% in those subjects also consented at a second stage to a companion rRCT.
conclusionThe PERa platform is met with high acceptance demonstrating efficient conduct of rRCTs embedded in routine radiation oncology practice. Future work to improve ePRO completions and automate harmonization with EMR data lakes have the potential to improve the quality of evidence generation and support learning health systems.
trial registrationNCT03378856: Registered on December 12, 2017. NCT04100174: Registered on September 20, 2019. NCT04178174: Registered on November 17, 2019. NCT05457699: Registered on July 04, 2022. NCT04405401: Registered on May 24, 2020. NCT04901234: Registered on May 17, 2021. NCT05317026: Registered on March 08, 2022.
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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.