A Practical Approach and Framework to Quality Management for Psychedelic Drug Development

Abstract

Sponsor companies and physician investigators engaged in clinical research, including those involved in psychedelic drug development, are to design quality into the clinical studies upfront as outlined in International Council for Harmonization (ICH) E8 R1, General Considerations for Clinical Studies, and ICH E6 R3, Guideline for Good Clinical Practice. Identification of what is critical to quality should be done at the time of protocol development, facilitating the assessment of risks to participants and data integrity. Sponsors should develop systems to manage quality throughout all stages of the trial process, per ICH E6, and ensure that quality oversight is commensurate with the risks associated in clinical development programs to support informed decision-making. Quality system elements should be designed to facilitate compliance, be flexible enough to accommodate shifting priorities, and mature with the growth of the company. For smaller start-up companies involved in psychedelic drug development programs, the same requirements apply as they would for the research and development of any other drug, biological, or device product. While there are challenges in developing a psychedelic for potential market approval due to controlled substance scheduling and the inclusion of psychological assistance or psychotherapy components, adherence to regulations is required to ensure participant safety and data reliability, which can be achieved through the establishment and maintenance of a robust quality management system.