ENROLLMENT OF ALL POPULATIONS IN CLINICAL TRIALS

To support the enrollment of all populations in clinical trials; further,

To advocate that drug product manufacturers and researchers conduct and report outcomes of pharmacokinetic, pharmacodynamic, and pharmacogenomic research for all populations to facilitate safe and effective dosing of medications for all patient populations; further,

To advocate that if such research considers age, sex, gender, ethnicity, or race, the reason for such consideration be based on validated ethical or scientific reasons and be specified in the research protocol; further,

To foster the use and development of postmarketing research strategies to support the safe and effective use of drug products for approved and off-label indications for all patient populations; further,

To advocate that pharmacists should be involved in the design of clinical trials to provide guidance on drug dosing, administration, and monitoring in all patient populations.

Rationale

Pregnant patients, fetuses, neonates, children, members of racial or ethnic minority groups, the elderly, and differently gendered individuals are populations in which the pharmacokinetic, pharmacodynamic, and pharmacogenomic properties of medications may differ from those of people typically enrolled in clinical trials. These differences can dramatically alter the behavior of drugs, producing supra- or subtherapeutic levels, which may result in adverse effects. While there has been legislation that provides incentives for drug manufacturers to study these effects, many drugs already approved by the FDA do not have such information or robust outcomes reporting for these at-risk populations. The need for this guidance is supported by the complexity of dosing for these patients, which varies based on medication- and patient-specific characteristics. There is a paucity of research in these patient populations, which is similar to the lack of preapproval studies in obese patients. ASHP also encourages independent clinical and practice-based research in which pharmacists are involved in the study design to further define clinical use of medications in the treatment of these patients, as well as clinician reporting of patient experience via published articles and clinical registries.