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Abstract Versus Concrete Risk Identification in Clinical Research in Japan: Randomized and Prospective Pilot Research

Hidenobu Kondo1,2, Shih-Wei Chiu3, Yukikazu Hayashi4,5

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Summary
This summary is machine-generated.

The risk-based approach (RBA) in clinical trials can be improved. Using a risk assessment form (RAF) with fewer abstract categories reduced errors and protocol deviations compared to a risk assessment tool (RAT).

Keywords:
Quality management systemRisk evaluationRisk identificationRisk reduction activitiesRisk-based approachRisk-based quality management

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Area of Science:

  • Clinical Research Methodology
  • Drug Development
  • Quality Management in Trials

Background:

  • The risk-based approach (RBA) for clinical trials, introduced in 2011-2012, aims to reduce quality issues by aligning risk reduction activities with identified risks.
  • A lack of standardized methodologies for risk identification, evaluation, and reduction planning hinders consistent RBA implementation.
  • This study evaluates the effectiveness of two distinct risk identification and evaluation methods within the RBA framework.

Purpose of the Study:

  • To compare the efficacy of two risk identification and evaluation methods in planning and implementing risk reduction activities.
  • To assess the impact of different risk assessment approaches on the quality of clinical trial conduct.
  • To determine the optimal method for identifying and evaluating risks to minimize errors and protocol deviations.

Main Methods:

  • Two risk identification and evaluation methods were selected: the risk assessment form (RAF) with fewer abstract categories and the risk assessment tool (RAT) with more concrete categories.
  • These methods were applied to a study on ponatinib blood concentration and treatment outcomes in chronic phase chronic myelogenous leukemia patients.
  • Clinical trial sites were randomized to implement risk reduction activities using either RAF or RAT, with subsequent comparison of mean errors and protocol deviations per subject visit.

Main Results:

  • The RAF group demonstrated a lower mean number of errors per subject visit compared to the RAT group.
  • The RAF group also showed a lower mean number of protocol deviations per subject visit than the RAT group.
  • These findings suggest a significant difference in the effectiveness of the two methods in controlling trial quality.

Conclusions:

  • Risk reduction strategies in clinical research are effectively implemented using methods that identify and evaluate risks within a limited set of abstract, quality-critical categories.
  • The RAF method, characterized by its abstract categorization, proved more effective than the RAT method in reducing errors and protocol deviations.
  • This study supports the use of simplified, abstract risk assessment tools for enhancing the quality and efficiency of clinical trials.