Above my desk, I have a couple of quotes printed out on what is now a rather grubby piece of paper. I put them there a long time ago and every so often, when my spirits are low, I read and reflect upon them.
The first is by Jimmy Carter, the 39th President of the United States. It reads, “If you fear making anyone mad, then you ultimately probe for the lowest common denominator of human achievement.” It reminds me that sometimes consensus is not enough. And that simple statement there may make a few people in the standards community mad. But consensus implies that we all agree and suggests a compromise. Sometimes a compromise is just not good enough. If you believe in something push for it and convince people and along the way they may just get mad until they come round to what you think is the best solution.
The second quote is from an unknown source. You could argue that it is not really a quote, but whatever its source, the words strike a chord. “Self-pity will parch your attitudes, it will paralyze your abilities, and it will put off your achievements. It prohibits excellence and prevents expansion.” Again standards development sometimes can leave you feeling down, the feeling that we are not moving fast enough, the constant criticism that we are not doing the right things in the right way with the right people, as well as the multitude of other comments, issues and ideas that arrive on your doorstep. The words remind me that just sitting there and complaining achieves nothing and indeed paralyzes you. We need to act.
So it is all the more satisfying when a piece of work that I was closely involved in bears fruit. A few days ago, I learned that the European Medicines Agency had released the final adopted version of a document entitled Reflection paper on expectations for electronic source data and data transcribed to electronic data collection tools in clinical trials available on the web here. If you read the document you will see that the European GCP inspectors have based their guidance on the eSDI work undertaken by CDISC between 2004 and 2006 where we looked at the use of electronic systems, electronic source documents and the existing regulatory framework including the US, European and ICH Good Clinical Practice. The eSDI paper can be found on the CDISC website here.
It is really heartening that the work of a small and dedicated team, which I was proud to co-lead with Becky Kush, has had a significant impact. But during the work there were a few tears shed and, while blood was not spilt, there was significant tension around why CDISC was looking at the issue. I remember attending a DIA conference on electronic diaries and being invited for a conversation at the end of one day. I entered a room and found a dozen or so representatives from industry waiting to question me on what CDISC thought it was doing. I spent over an hour defending CDISC’s work. We did make people mad but we also achieved something notable; clarity on how our industry can make use of electronic Source Data and how the CDISC Operational Data Model (ODM) can be used to support such. The two quotes helped me maintain the correct perspective through one or two dark days of eSDI.
Not only has the eSDi paper influenced the work of the EMA but the eSDI work with the ODM provide two of the many foundations stones for the work undertaken by my good friend Landen Bain in the quest for integrating Electronic Health Records into clinical research. It was in the middle of the eSDI work in November of 2005 that Landen and I sat in a small Italian restaurant in Libertyville just north of Chicago. The table we sat at had a paper tablecloth and by the end of the evening the cloth was covered in drawings, notes and ideas that went on to form the basis of the regulatory compliance parts for the IHE RFD profile that Landen went on to develop and fed into the scenarios described within the eSDI paper published a year later.
So I commend the EMA document to you along with the eSDI work on which it was based. It can bring regulatory clarity wherever you collect electronic data, be it EDC, ePRO, EHR or any other technology.
