Reviewing concomitant medications for participants in oncology clinical trials

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Abstract

Purpose

The importance and key components of clinical medication reviews for participants in oncology clinical trials are described, and drug– drug interactions (DDIs) associated with new oncology drug classes are discussed.

Summary

Use of investigational drugs is a mainstay of adult oncology clinical trials and has led to discovery of new oncology drug classes, including immunotherapy agents and oral targeted therapies, as well as novel chemotherapy delivery methods. As sponsor-supplied DDI information on investigational drugs and drug classes is typically limited and often inconsistent, a clinical medication review to assess the potential for DDIs is recommended for all patients enrolling in oncology clinical trials. A simplified approach to performing such reviews includes (1) evaluating the trial protocol for DDI risks, (2) meeting with the patient face-to-face to perform the review, (3) making medication-related recommendations based on the findings of the patient encounter, and (4) documenting review findings in the medical record. Pharmacists can create a personalized “concomitant-medication review guide” listing key medication-use information in table format to assist other clinicians in preventing and assessing DDIs during a patient's clinical trial participation.

Conclusion

Each investigational drug and new drug class in oncology has a unique DDI profile. It is essential that patients be screened for DDI risks prior to clinical trial participation and that pharmacists and clinical investigators have clear guidelines for managing DDIs. Performing a clinical medication review is one approach to simplifying this process and ensuring patient safety.

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