Ethics, regulations, and clinical development of precision medicine: Activating with molecular imaging

Abstract

“Precision medicine” is becoming a keyword toward new and more effective healthcare in the twenty-first century, a concept evolved from “personalized medicine." Therefore, it is a prerequisite for the community of molecular imaging to clarify elements of ethics, regulations, and clinical development strategies to achieve the goal of precision medicine, activated with imaging technologies. Through literature review and continuous discussion with people of related communities, we identified key elements from view of regulations and clinical development strategies as follows: (1) quality assurance and standardization of methodologies and procedures of imaging technologies and (2) formulation of larger-scale global clinical trial network and imaging archives, both of which would accelerate regulatory approval of new therapeutic drugs and diagnostic technologies. Additionally, key elements of ethics are as follows: (1) view of individual ethics to protect human rights and human dignity, i.e., (i) privacy protection, (ii) right to know and right not to know, as well as (iii) presymptomatic diagnosis consultation, and (2) view of collective ethics to assure social value such as (i) clinical trial registration and data sharing, (ii) justifiable commercialization, and (iii) preventing exploitation and stigmatization. In conclusion, precision medicine can be activated with molecular imaging, through more global collaborative initiatives, which recognize and have a profound understanding of the characteristics of science, regulations, and ethics in the era of precision medicine.