Unintended Regulatory Caused Early Death—A Difficult Endpoint in Cancer Patient Care and Treatment

SIMPLE SUMMARY: This is a position paper by a clinical oncologist. It voices concerns about political decision making and regulatory time frames for drug availability, both of which are critical for patient care in life-threatening diseases such as cancer. ABSTRACT: The pharmacological armory against cancer has been growing, with many new drugs approved. The Good Clinical Practice (GCP)-based Clinical Trials Directive was adopted in the EU in 2001, with the important objectives of achieving better patient safety and improved quality of clinical trial conduct. However, clinical experience with the implementation of the regulation raises the question as to whether aspects of this regulatory framework can cause harm to some patients. This question also arises in daily clinical cancer patient care when the time between the publication of pivotal study results and their approval, and details of post-approval regulations, are scrutinized. Clinical observations, provocatively summarized as “unintended regulatory caused early death”, are discussed.