A Tribute to Joachim Röhmel upon his retirement from the Federal Institute of Drugs

✍ Scribed by Robert T. O'Neill

• Publisher: John Wiley and Sons
• Year: 2005
• Tongue: English
• Weight: 35 KB
• Volume: 47
• Category: Article
• ISSN: 0323-3847
• DOI: 10.1002/bimj.200410091

✦ Synopsis

I first met Joachim Raehmel during the mid 1980's at a meeting in the Frankfort area to which I had been invited by Joachim Vollmar to give a talk about statistical issues in drug evaluation and regulation. I recall fondly the social hour with German statisticians including Bernd Streitberg one of Joachim's collaborators. My next contact with Professor Raehmel came during the 1989-1990 year I spent in Basel, Switzerland at the Department of Research in the medical school of the University of Basel. That experience was beneficial both for me and for Joachim as it began for both of us what turned out to be many changes in the regulatory arena where statistics played a part in influencing these changes, and where Joachim played a major role both in Germany, Europe and the international scene. I would like to take this opportunity to chronicle some of my recollections of that period up to the present time of his retirement from the BfArM.

Joachim came from Berlin to Basel to attend virtually all eight of my Topics in Therapy Evaluation and Review (TITER) that I gave at the Department of Research, University of Basel during 1989 to 1990. This was an exciting time of change in Europe and indeed for me as I was able to interact with many of the approximately 350 attendees and invited presenters of the lectures and hear a variety of perspectives on biostatistics, and clinical drug development and regulation in Europe. At the time, I was extremely curious as to why Europe, and in particular Germany, the United Kingdom and France did not have any statistical core support in the regulatory agencies especially to deal with new statistical guidance development and with many of the more difficult issues that were being faced in regulation and soon to surface under the International Conference on Harmonization initiative. My interaction with Joachim in Basel, in my opinion, had long term beneficial consequences for Joachim in his soon to be new career at BfArM, for me in my regulatory role and for my ability to interact with German regulators at the Bfarm, and for establishment of a relationship that would benefit the ICH process that developed the ICH E9 guidance on 'Statistical Principles for Clinical Trials'.

In 1991, Joachim was soon hired into a statistical leadership position in BfArM and began to lay the basis for many future changes and to influence statistical thinking in drug regulation. He was professionally active during the 1990's in many areas and for the next 10 years lectured with me and others in the European Course in Pharmaceutical Medicine in Basel. In particular, Joachim participated in a very important way in the development and completion of the precendent setting ICH E9 guidance on 'Statistical Principles for Clinical Trials'. He also was able by his example and efforts to convince his colleagues at BfArM to increase the statistical support as the value of professional statistical advice in drug regulation was clearly evident to his colleagues from his work. In this regard, Joachim was able to increase the importance and visibility of regulatory statistics in Germany and Europe during a very seminal period of the 1990's and into the new millennium.

In March 2003, Joachim invited me to give a series of lectures to his medical and statistical colleagues in BfArM in order to expose them to some of the statistical thinking that was developing at FDA in the area of safety assessment, an area not as well developed as efficacy evaluation, where statisticians have made major contributions over the years. One talk 'FDA Approaches to the pre-market evaluation of safety data: some clinical and statistical considerations' focused on pre-market issues and the other 'FDA Approaches to post-market evaluation of safety data: Some clinical, epidemiological and statistical considerations' focused on post-approval issues. This opportunity allowed me to get