Three organizations related to clinical trials and clinical studies jointly formulated the "Data Integrity Declaration

Dear all

The Japan SMO Association, the Japan CRO Association, and the Japan Pharmaceutical Manufacturers Association Drug Evaluation Committee have jointly developed the "Data Integrity Declaration - Our Declaration" to ensure the reliability of clinical trials and clinical studies. and published it today on their respective websites.

Data Integrity means that data is complete, consistent, and accurate. The creation and development of new drugs requires a variety of data obtained from clinical trials, and the cooperation of patients is essential for the production of such data. When patients participate in clinical trials and trials, they express their various wishes to overcome their diseases. In order not to betray these wishes and to make use of them for future medical treatment, each of us must act with an awareness of the importance of ensuring data integrity, and this declaration is based on our wish that all people involved in clinical trials and clinical studies will always be aware of the importance of this.

In April 2020, the three organizations issued the "Implementation and Management of Clinical Trials and Clinical Trials under the Spread of Novel Coronavirus Infections (COVID-19). Since then, in addition to the impact of COVID-19, the three organizations have continued to study the joint declaration and have come to formulate it with the aim of having all parties concerned reaffirm the importance of ensuring the reliability of clinical trials and clinical studies in an environment where various methods and approaches regarding clinical trials and clinical studies are undergoing major changes from the conventional style. The declaration has been developed through the study of a joint declaration by the three organizations.

　The three organizations will work together to disseminate the Declaration so that all those involved in clinical trials and clinical trials will understand the ideas contained in the Declaration and incorporate them into their own action guidelines. We will continue to work together to improve the quality of clinical trials and to create new medicines and to nurture new medicines for as many patients as possible.

Japan Pharmaceutical Manufacturers Association: https://www.jpma.or.jp/information/evaluation/results/message/di.html