Patient-Centered Cancer Drug Development: Clinical Trials, Regulatory Approval, and Value Assessment

Author:

Gyawali Bishal1,Hwang Thomas J.1,Vokinger Kerstin Noelle12,Booth Christopher M.34,Amir Eitan5,Tibau Ariadna6

Affiliation:

1. Program on Regulation, Therapeutics, and Law, Brigham and Women's Hospital and Harvard Medical School, Boston, MA

2. Institute for Primary Care and Health Outcomes Research, University of Zürich, Zürich, Switzerland

3. Division of Cancer Care and Epidemiology, Queen’s University Cancer Research Institute, Kingston, Ontario, Canada

4. Department of Public Health Sciences, Queen’s University, Kingston, Ontario, Canada

5. Division of Medical Oncology and Hematology, Department of Medicine, Princess Margaret Cancer Centre and the University of Toronto, Toronto, Ontario, Canada

6. Department of Oncology, Hospital de la Santa Creu i Sant Pau, Institut d’Investigació Biomèdica Sant Pau and Universitat Autònoma de Barcelona, Barcelona, Spain

Abstract

Historically, patient experience, including symptomatic toxicities, physical function, and disease-related symptoms during treatment or their perspectives on clinical trials, has played a secondary role in cancer drug development. Regulatory criteria for drug approval require that drugs are safe and effective, and almost all drug approvals have been based only on efficacy endpoints rather than on quality-of-life (QoL) assessments. In contrast to Europe, information regarding the impact of drugs on patients’ QoL is rarely included in oncology drug labeling in the United States. Until recently, patient input and preferences have not been incorporated into the design and conduct of clinical trials. In recent years, a more in-depth understanding of cancer biology, as well as regulatory changes focused on expediting cancer drug development and approval, has allowed earlier access to novel therapeutic agents. Understanding the implications of these expedited programs is important for oncologists and patients, given the rapid expansion of these programs. In this article, we provide an overview of the role of QoL in the regulatory drug–approval process, key issues regarding trial participation from the patient perspective, and the implications of key expedited approval programs that are increasingly being used by regulatory bodies for cancer care.

Publisher

American Society of Clinical Oncology (ASCO)

Subject

General Medicine

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