The Concept of Clinical Data Interchange Standards Consortium (CDISC) and Academia’s Sought-After Response
On January 30, 2018, the last “Academia Clinical Development Seminar” of this fiscal year was held. We invited Dr. Kiyoteru Takenouchi who is from Translational Research Informatics Center (TRI) as a lecturer. Dr. Takenouchi gave a lecture entitled "The Concept of Clinical Data Interchange Standards Consortium (CDISC) and Academia’s Sought-After Response."
Although the CDISC format has become compulsory for when pharmaceutical companies apply for a new pharmaceutical for sale and marketing, the PMDA also recommends the utilization of the CDISC format when investigator-initiated clinical trials are conducted in academia as well. In recent years, seminars related to the CDISC have been conducted in a number of locations throughout Japan, but there are many voices that state that academia does not fully understand the concept. Under these circumstances, we, therefore, decided to have this seminar in response to the requests of implementing a lecture on the CDISC.
At the beginning of the seminar, Dr. Takenouchi emphasized, "There is a tendency to misunderstand in academia and particularly in ‘translational research field’ that the CDISC is NOT necessary, but I would like to tell you today that that is not true."
To tell the truth, it is embarrassing to admit that we did not fully understand the CDISC overview, so we were planning to study only the outline of the CDISC. However, most participants were full of enthusiasm for learning about the CDISC seriously, because the seminar included not only conceptual content but also many practical examples, and we all were satisfied with the explanations on the significance and usefulness of the CDISC.
The Academia Clinical Development Seminar usually has a 30-minute Q & A session after an hour of lecture. However, prior to the lecture, Dr. Takenouchi told us that "It will take a little over an hour, today," Indeed, it took quite more than an hour to complete the explanation of the handout consisting of nearly 70 pages. Despite the fact, all the participants listened to the session attentively, clearly leaning forward and deepening their understanding of the matter. In the Q & A session, many questions were made by doctors and researchers who are in charge of the research and development of medical drugs and devices.
Dr. Takenouchi answered each question sincerely. Among those, some questions and comments were sharply critical against the CDISC, but these were also necessary to discuss and promote understanding of the CDISC for the implementation of its format in academia, said Dr. Takenouchi. It was a positive and meaningful discussion.
We asked impressions of this lecture to the researchers who participated in the seminar. Some representative responses were: "I was very thankful because the definitions of data and metadata were tightly explained" and "I was satisfied with the lecture content such as with the explanation of the differences between SD and CDASH, which were easy to understand". It seems that the almost all audience felt satisfaction for his lecture. We believe that it was a valuable lecture for participants who were from various kinds of clinical as well as basic research fields, and that his talk was very fitting as the last Academia Clinical Development Seminar in this fiscal year.
We will prepare and provide seminars for the next fiscal year for researchers would like to know and understand how they should proceed in research and development that are related to the implementation of translational research as well as global clinical studies.
We are waiting for your opinions and are looking forward to seeing you again.
Thank you very much.