Three Organizations Involved in Clinical Trials Jointly Draft a “Data Integrity Declaration”

March 24, 2022
Japan SMO Association
Japan CRO Association
Japan Pharmaceutical Manufacturers Association

To Whom It May Concern
　
The Japan SMO Association, the Japan CRO Association, and the Drug Evaluation Committee of the Japan Pharmaceutical Manufacturers Association have jointly formulated the “Data Integrity Declaration—Our Declaration” to ensure the reliability of clinical trials.The three organizations have disseminated this declaration to their respective members involved in clinical trials and have published it today on their respective websites.

Data integrity refers to data that is complete, consistent, and accurate.The development and advancement of new drugs require various types of data obtained from clinical trials, and patient cooperation is essential for this data. When patients participate in clinical trials, they do so with a variety of hopes and aspirations for overcoming their diseases.This declaration is based on our desire to ensure that we do not betray those hopes and that the data contributes to the future of medicine. To this end, each of us must act with a keen awareness of the importance of ensuring data integrity, and we hope that everyone involved in clinical trials will always feel the significance of this principle close to their hearts.

In April 2020, these three organizations issued the “ Implementation and Management, etc. of Clinical trials under the spread of the novel coronavirus (COVID-19).”Since then, amid an environment where various methods and approaches to clinical trials are undergoing significant changes from traditional practices—compounded by the impact of COVID-19—we have continued to discuss and ultimately formulated this joint declaration with the aim of reaffirming the importance of ensuring the reliability of clinical trials to all stakeholders.

　Moving forward, the three organizations will jointly carry out activities to promote the widespread adoption of this declaration so that all stakeholders involved in clinical trials can understand the spirit behind it and incorporate it into their own guidelines for action.Through these efforts, the three organizations aim to improve the quality of clinical trials, thereby contributing to both the development of new drugs and the advancement of existing ones, with the goal of making them available to as many patients as possible.