The session concluded with a panel discussion, composed of the following high-level speakers and regulatory officials: Dr. Steve Wilson, FDA; Dr. Ron Fitzmartin, FDA; Dr. Eileen Navarro Almario, FDA; Dr. Mayumi Shikano, Japan PMDA; Dr. Pierre-Yves Lastic, CDISC Board Chair, Sanofi; Dr. Margaret Haber, NIH/NCI; Enrique Avilès, C-Path; Doug Warfield, FDA; Lisa Lin, FDA; Jack Zhang, FDA; and Dr. Laura Esserman, UC San Francisco.
As is tradition, Dr. Steve Wilson of the FDA (CDER-Statistics) introduced this final panel discussion and offered his thoughts on this Interchange. Of note was his emphasis on the importance of the CDISC standards through the example of the development of practical, Ebola-specific case report forms earlier in the week, a meeting he had joined. As a member of the U.S. Public Health Service, he could be sent to join those helping patients in Africa and he showed photos of some of these individuals on the ground there now. He mentioned that at FDA-CDER, it is now the expectation that all data is supposed to be sent to the FDA in a standard way, that this is a major change from before. He ended his comments by expressing to the audience that the theme (“Embracing a Changing Landscape”) was apt this year, but that “it’s not just a changing landscape, it’s an expanding universe. You are the landscape; celebrate your success!”
One of the key items identified during the panel discussion was the necessity for us to do more to engage the patient audience about what we are doing in standards development. It was noted, however, that when trying to bridge across from the clinical trial process to the patient advocacy groups that we should remember to explain what we do in common language, to refrain from the overuse of acronyms, and to remember to let people know about what we are ultimately trying to accomplish through our work.
Another key topic discussed was the ‘over collection’ of data and how clinicians do not feel that they have the power to negotiate with trial sponsors on this. There was a suggestion that everyone, including clinicians, sponsors and regulators, should be in agreement on the data to be collected and the standards before the trial is initiated.
Closing remarks from the panelists were shared. Dr. Lastic: “You no longer ask the question IF you use CDISC; it is not a question anymore.” Enrique Aviles: “Current approaches to develop cures take too long. We need a force multiplying time machine--apply standards end to end, share data across organizations, and teamwork.” Dr. Shikano of PMDA: “I learned that it is important for PMDA to participate in this collaborative discussion.” Dr. Fitzmartin: “This meeting has impressed me – there has been more discussion about the patient. This week we have certainly seen change. I am excited about the tremendous amount of collaboration.” Margaret Haber: “There is a lot of work to be done, but a lot to be excited about. NCI Enterprise Vocabulary Services has seen enormous growth and collaboration. We begin to have the chance for synergies in healthcare and research.”
By Andrea Vadakin, CDISC Public Relations Manager
Strength through Collaboration
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