Final Session at the 2014 CDISC International Interchange – Keynote and Panel Discussion


The last session of the 2014 CDISC International Interchange was the culmination of all of the major messages at the conference structured into one, masterfully crafted presentation and panel discussion. My goal in this blog entry is to deliver some of the key messages and ideas voiced during this session, but please note that to truly appreciate the depth of knowledge of the speakers and the timely issues that are discussed during this conference, it was really important to be a part of the audience.


Dr. Laura Esserman delivered the final Keynote address, presenting on eSource and the Quest to Compress Trial Timelines and Find Better Treatments: The I-SPY Master Trial Evolution. Dr. Esserman was a fantastic speaker, and passionately expressed some of the issues for breast cancer research for which most of us are already well aware, namely, that the cost for bringing a new drug to market continues to skyrocket, and innovation in trial design and data collection tools are necessary improve efficiency while decreasing costs. Dr. Esserman begged the question of why clinical trial phases are not linked together, and mentioned that data should be gathered correctly at the onset, that creating “paper copies of electronic records is ridiculous.” She also recommended that trials should always be patient-focused: “We don’t start with the patients in mind; we need to redesign the trial process--- design a trial that you would want your mother to go on, that you would be willing to be on yourself.”


On the topic of using EHRs for research, Dr. Esserman spoke about the IHE Retrieve Form for Data Capture (RFD) profile and the rationale for using EHRs and eSource: “A standards-based solution exists. It requires courage, imagination and collaboration” to implement. This solution will work across varying EHRs and EDCs and enables the use of different technologies at each site conducting the research study. This also speaks to the research clinicians.


Perhaps it was work done earlier in the week by team members and volunteers to help standardize Ebola-specific case report forms (see article in the November eNews), but this ending presentation really drove home the underlying message of how CDISC standards have the ability to directly impact the patient community. This Interchange, more than any other in my experience, demonstrated that the landscape of healthcare and clinical research is indeed changing.


Strength through Collaboration


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