Are We Ready to Include Organ-impaired Patients in Oncology Trials?

An ACCP Policy Statement: "Are We Ready to Include Organ-impaired Patients in Oncology Trials? A Clinical Pharmacology Perspective on Recent Recommendations"

Ashburn, May 1, 2018:  The American College of Clinical Pharmacology (ACCP) published a Policy Statement which reviews specific ways in which clinical pharmacology can and should make an impact in the effort to include organ-impaired patients in oncology trials and identifies key discussions among industry, regulators and clinicians which are necessary prior to widespread adoption of expanded eligibility criteria across oncology trials.

The ACCP Policy Statement is a response and call for discussion based on recent recommendations put forth from a working group initiative that advises patients with renal and hepatic impairment be enrolled into oncology clinical trials. These recommendations were generated from a collaboration between the American Society of Clinical Oncology (ASCO), Friends of Cancer Research (FOCR) and the US Food & Drug Administration (FDA), and aim to increase patient participation in and real-world extrapolation of results from oncology studies.

“This Policy statement highlights the importance of clinical pharmacology in the development of oncology drug development”, said Michael Fossler, chair of the ACCP Public Policy Committee. “Collecting special population data during the development of drugs used to treat cancer is vital for the safe and effective use of these agents, but it is important to collect these data in a way that protects both patient safety and data integrity”.

The full statement can be viewed below:

Are We Ready to Include Organ-impaired Patients in Oncology Trials? A Clinical Pharmacology Perspective on Recent Recommendations

Joanna C. Masters, PharmD and Peter H. Wiernik, MD, FCP
First Published: 17 April 2018
DOI: 10.1002/jcph.1127

About the American College of Clinical Pharmacology

Headquartered in Ashburn, VA, the American College of Clinical Pharmacology (ACCP) is a non-profit membership association with a 45+ year history of providing exceptional interprofessional, accredited Continuing Education programs, publications, networking and other career-enhancing opportunities to a wide spectrum of healthcare professionals using clinical pharmacology in disciplines from research to patient care.