Trial reportTherapeutic innovation & regulatory science2025
Abstract Versus Concrete Risk Identification in Clinical Research in Japan: Randomized and Prospective Pilot Research on the Effect of Risk Reduction Activities in a Risk-Based Approach.
Trial report in Therapeutic innovation & regulatory science, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
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.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
1 citing paper in PubMed.
- Development of a Novel Risk Assessment Scale to Improve the Consistency and Reliability of Risk-Based Approaches in Clinical Trials.Therapeutic innovation & regulatory science · 2026Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
5 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundThe risk-based approach (RBA) of clinical trial was first introduced in 2011-2012. RBA necessitates implementing risk reduction activities that are proportionate to risk in order to reduce avoidable quality issues. However, there is no consistent methodology or research for identifying and evaluating risks and planning risk reduction activities. We aimed to evaluate risk reduction activities and their effects by using two risk identification and evaluation methods.
methodsAmong the risk identification and evaluation methods, we selected one method with the lowest number of categories for identifying risks [risk assessment form (RAF)] and one with the highest number [risk assessment tool (RAT)]. Each method was used to identify and evaluate risks in and plan risk reduction activities for the research on ponatinib blood concentration and treatment outcome in patients with chronic phase chronic myelogenous leukemia. RAF and RAT can identify risk using abstract questions and a list of concrete risks, respectively. The sites were randomized into two groups to implement planned risk reduction activities using RAF and RAT and to compare the mean of errors and protocol deviation per subject visit between the two groups.
resultsThe mean of errors per subject visit and the mean of protocol deviation per subject visit were lower in the RAF group than in the RAT group.
conclusionsOur study indicates that risk reductions can be successfully implemented by using a method to identify and evaluate risks in a small number of abstract categories that are critical to quality of clinical research.
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Registered trials
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.