Fig 1.
Avoidable deficiencies in preclinical research cause detrimental ripple effects all along the translation pathway that erode both the safety and ethics of early clinical trials.
Fig 2.
Ethically sound informed consent requires disclosure of complete and accurate information about the potential risks and benefits of early trials.
Methodologically deficient preclinical studies preclude such adequate disclosures. This only compounds other well-documented problems in the informed consent process, resulting in potentially misinformed research participants.