✓ Translated by DotMD AI Clinical Council Source: Amyotrophic lateral sclerosis & frontotemporal degeneration • Phase III Randomized Trial

Verify Primary Source: NIH PubMed PMID #40576049 ↗

Phase III Randomized Trial: Participant, site personnel and sponsor perspectives on decentralized trial features in COURAGE-ALS (N = 486)

Original Paper Title: “Participant, site personnel and sponsor perspectives on decentralized trial features in COURAGE-ALS: a randomized clinical trial”

Elena Rostova (AI Quant) Rigor Score

93 / 100

Sample Size (Participants)

N = 486

Evidence Classification

Phase III Randomized Trial

Sarah Jenkins, RN (AI Plain-English Editor) • Key Takeaways

RVs influenced the decision to pursue the trial in 13/31 participants. Remotely performing forced vital capacity (FVC) was a concern for 17/43 (40%). Survey response rate for SP was 41% (141/344). The trial was viewed as less time/labour for the site versus a traditional design by 52/136 (38%) of SP.
Study Design & Sample: Phase III Randomized Trial published in Amyotrophic lateral sclerosis & frontotemporal degeneration (N = 486 human participants).
Biostatistical Rigor Score: 93/100 audited by Elena Rostova (AI Biostatistician & openFDA Quant).

What the Study Found (In Plain English)

Published in Amyotrophic lateral sclerosis & frontotemporal degeneration (2025), this phase iii randomized trial evaluating 486 human participants investigated: To describe participant, site personnel (SP) and sponsor perspectives regarding their experiences with a decentralized clinical trial (DCT). Key clinical takeaway: RVs influenced the decision to pursue the trial in 13/31 participants. Remotely performing forced vital capacity (FVC) was a concern for 17/43 (40%). Survey response rate for SP was 41% (141/344). The trial was viewed as less time/labour for the site versus a traditional design by 52/136 (38%) of SP.

Dr. Lin (AI Evidence Lead): Statistical Endpoints & Numbers

Primary Endpoint & Quantitative Summary (Amyotrophic lateral sclerosis & frontotemporal degeneration, 2025-11-15; N = 486; Rigor 93/100): RVs influenced the decision to pursue the trial in 13/31 participants. Remotely performing forced vital capacity (FVC) was a concern for 17/43 (40%). Survey response rate for SP was 41% (141/344). The trial was viewed as less time/labour for the site versus a traditional design by 52/136 (38%) of SP.

Study Limitations & Caveats Before You Act

Clinical trials evaluate specific inclusion/exclusion cohorts under protocol-controlled conditions (Phase III Randomized Trial). Individual response, hepatic/renal clearance, CYP450 drug interactions, and baseline comorbidities vary; verify applicability with a board-certified physician before modifying any prescription or supplement regimen.

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