Where are randomized trials necessary: Are smoking and parachutes good counterexamples?

Powell, Kerrington; Prasad, Vinay

doi:10.1111/eci.13730

Cited by 4 publications

(4 citation statements)

References 18 publications

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“…The concept of when a randomized trial is needed has been recently debated ( 46 ). Indeed, precisely when a randomized trial is necessary is not entirely clear.…”

Section: Discussionmentioning

confidence: 99%

“…There does not seem to be robust consensus on this issue. One proposal has been that a trial may be needed when an intervention is thought to be beneficial by physicians, but offers only modest benefit with the potential for harm ( 46 ). Another indication would be when a standard of care is debated, or poorly understood, early or mid-phase randomized trials provide an important strategy to identify an optimal approach.…”

Section: Discussionmentioning

confidence: 99%

“…Its something that should be very carefully reflected on by all radiation oncologists. The concept of when a randomized trial is needed has been recently debated (46). Indeed, precisely when a randomized trial is necessary is not entirely clear.…”

Section: Selective Focal Rt Dose Escalation Either Focal Boosting or ...mentioning

confidence: 99%

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Adaptive magnetic resonance image guided radiation for intact localized prostate cancer how to optimally test a rapidly emerging technology

et al. 2022

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IntroductionProstate cancer is a common malignancy for which radiation therapy (RT) provides an excellent management option with high rates of control and low toxicity. Historically RT has been given with CT based image guidance. Recently, magnetic resonance (MR) imaging capabilities have been successfully integrated with RT delivery platforms, presenting an appealing, yet complex, expensive, and time-consuming method of adapting and guiding RT. The precise benefits of MR guidance for localized prostate cancer are unclear. We sought to summarize optimal strategies to test the benefits of MR guidance specifically in localized prostate cancer.MethodsA group of radiation oncologists, physicists, and statisticians were identified to collectively address this topic. Participants had a history of treating prostate cancer patients with the two commercially available MRI-guided RT devices. Participants also had a clinical focus on randomized trials in localized prostate cancer. The goal was to review both ongoing trials and present a conceptual focus on MRI-guided RT specifically in the definitive treatment of prostate cancer, along with developing and proposing novel trials for future consideration. Trial hypotheses, endpoints, and areas for improvement in localized prostate cancer that specifically leverage MR guided technology are presented.ResultsMultiple prospective trials were found that explored the potential of adaptive MRI-guided radiotherapy in the definitive treatment of prostate cancer. Different primary areas of improvement that MR guidance may offer in prostate cancer were summarized. Eight clinical trial design strategies are presented that summarize options for clinical trials testing the potential benefits of MRI-guided RT.ConclusionsThe number and scope of trials evaluating MRI-guided RT for localized prostate cancer is limited. Yet multiple promising opportunities to test this technology and potentially improve outcomes for men with prostate cancer undergoing definitive RT exist. Attention, in the form of multi-institutional randomized trials, is needed.

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“…The concept of when a randomized trial is needed has been recently debated ( 46 ). Indeed, precisely when a randomized trial is necessary is not entirely clear.…”

Section: Discussionmentioning

confidence: 99%

Section: Discussionmentioning

confidence: 99%

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Adaptive magnetic resonance image guided radiation for intact localized prostate cancer how to optimally test a rapidly emerging technology

et al. 2022

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“…RCTs are considered the gold standard of medical evidence, gaining popularity in the mid to late twentieth century due to their ability to minimize confounding, solve problems related to time zero (e.g., guarantee time), and limit multiple hypothesis testing [ 2 , 3 ]. RCTs are particularly useful in biomedicine, where the size of treatment effects are often modest, and interventions are typically delivered at the individual level (with limited clustering or spillover effects) and with the expectation that they will benefit the participant.…”

Section: The Parachute Analogy In Biomedicinementioning

confidence: 99%

A novel trial methodology to test interventions with very large effect sizes: the case of dostarlimab in mismatch repair-deficient, locally advanced rectal cancer

Powell

Thibault

Prasad

2022

Trials

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Dostarlimab (Jemperli, GlaxoSmithKline) is an anti-programmed death receptor-1 monoclonal antibody (anti-PD-1) recently tested in a non-randomized, phase II trial (NCT04165772) which included patients with mismatch repair-deficient, locally advanced rectal cancer. Among the first 12 patients treated with dostarlimab, 100% achieved a clinical complete response with no patients experiencing progression or recurrence to date. Most impressive, none required chemotherapy, radiotherapy or surgery the prevailing standard of care. In this paper, we discuss the impressive results of this trial and how they relate to cancer policy, as well as propose a novel trial methodology to assess dostarlimab.

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Autologous tumor lysate-loaded dendritic cell vaccination in glioblastoma: What happened to the evidence?

Thibault¹,

Migliorini²

2023

Revue Neurologique

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Where are randomized trials necessary: Are smoking and parachutes good counterexamples?

Cited by 4 publications

References 18 publications

Adaptive magnetic resonance image guided radiation for intact localized prostate cancer how to optimally test a rapidly emerging technology

Adaptive magnetic resonance image guided radiation for intact localized prostate cancer how to optimally test a rapidly emerging technology

A novel trial methodology to test interventions with very large effect sizes: the case of dostarlimab in mismatch repair-deficient, locally advanced rectal cancer

Autologous tumor lysate-loaded dendritic cell vaccination in glioblastoma: What happened to the evidence?

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