The Importance of Participant Tracking When Conducting Clinical Pharmacology Drug Trials

Feasibility of Using Population Pharmacokinetics‐Based Virtual Control Groups in Organ Impairment Studies

“…Enrollment of a healthy control group can raise some of the ethical issues related to the enrollment of healthy participants in Phase 1 studies. 5 These concerns include the risk of adverse events of the drug without gaining any medical benefits, the exposure to uncomfortable procedures and the need for confinement in a clinic for a period under certain restrictions. 6 While evaluations in healthy participants are very informative in early phases of drug development in characterizing the pharmacokinetics, safety, and tolerability of a drug candidate, repetitive evaluations in healthy participants may not be warranted when the pharmacokinetic profile of the drug is adequately characterized in that population, and when the new evaluations are not adding meaningful dimensions in our knowledge about the drug.…”

“…Enrollment of a healthy control group can raise some of the ethical issues related to the enrollment of healthy participants in Phase 1 studies 5 . These concerns include the risk of adverse events of the drug without gaining any medical benefits, the exposure to uncomfortable procedures and the need for confinement in a clinic for a period under certain restrictions 6 .…”