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Area of Science:

  • Biomedical Ethics
  • Clinical Trial Design
  • Preclinical Research Evaluation

Background:

  • Assessing the risk/benefit balance in early-phase clinical trials relies on evaluating preclinical evidence of an intervention's promise.
  • Current guidance for stakeholders making these moral evaluations is limited.
  • Ethics committees, investigators, and sponsors require structured methods for this critical assessment.

Purpose of the Study:

  • To develop a systematic and transparent process for assessing the clinical promise of novel interventions based on preclinical data.
  • To provide guidance for stakeholders involved in the moral evaluation of risk and benefit in early-phase studies.
  • To enhance the rigor of preclinical evidence assessment for clinical development decisions.

Main Methods:

  • A two-step structured process for assessing clinical promise was developed, drawing on published preclinical study design guidelines.
  • Step 1 involves gathering preclinical studies, assessing treatment effect magnitude, and identifying threats to valid clinical inference.
  • Step 2 incorporates comparative analysis with similar agents in the same reference class that have undergone clinical development.

Main Results:

  • The proposed approach offers a systematic method for evaluating preclinical evidence to determine clinical promise.
  • It provides a framework for adjusting initial assessments based on the performance of similar agents in clinical development.
  • This structured assessment informs the moral evaluation of risk and benefit in early-phase trials.

Conclusions:

  • The developed process provides a systematic and transparent method for assessing the clinical promise of novel interventions from preclinical evidence.
  • This systematic approach supports ethical decision-making regarding risk and benefit in early-phase clinical trials.
  • While acknowledging limitations, the method aims to improve the evaluation of candidate interventions before human testing.