Prof. Dr. Mical Paul: “I’m very happy that I have research to accompany clinical practice”

Prof. Dr. Mical Paul is Director of Infectious Diseases Institute and COMBACTE’s Principal Investigator at Rambam Medical Center in Israel. She is Associate Professor at The Ruth and Bruce Rappaport Faculty of Medicine, Technion, Israel Institute of Technology. In her blog, Dr. Paul speaks about how much she enjoys having her clinical practice supported by research, and why she considers COMBACTE a very attractive project to work for.

“Curiosity is an integral part of good medicine. Research arises from questions that we, as physicians, ask ourselves on patient management. Questions that cover gaps in diagnosis, treatment and unknowns on the risk for disease and its outcomes. I became a researcher by observing my mentors ask the questions and then learning to ask and to formulate these questions into research. I treat patients as my main profession. This is my interest and the reason I practice medicine. But, I’m very happy that I have research to accompany clinical practice. I am afraid that without research I would have become a very bored, boring and tired physician.

The dissociation between investigator-initiated research and drug development always bothered me. Why are the trials testing new drugs so different from the studies that we, researchers, do? Why is it that I cannot find my patient in randomized controlled trials assessing new antibiotics? Why did they test outcomes that are irrelevant to my patient? I found the COMBACTE project very attractive because of the unique and novel collaboration between independent academia without conflicts of interests and the pharma. Uniting academic investigators with the pharma to develop new antibiotics is a right way forward. I am very grateful to Marc Bonten for inviting me as a co-leader in a phase 3 randomized controlled trial assessing a new antibiotic potentially active against carbapenem-resistant enterobacteriaceae, one of the most important CDC and WHO priority pathogens. We, the clinical researchers, could define the patient population in need of this new antibiotic and the relevant outcomes to assess. The industry could teach us how to ensure perfect data collection and timely trial completion.

I wish it were so. Unfortunately, the big pharma are tied by regulations and restrictions allowing very little space for academic mindflow. I wish we could dictate the patient population that is recruited into a trial assessing a much-needed antibiotic. I wish we could perform trials powered to assess real outcomes. I wish that the pharma could be much less concerned by minor toxicity and more concerned with the health of very sick patients who die from infections and need these new antibiotics. COMBACTE seems the right place to start making these changes and I hope we’ll get there one day. Having started with real questions that came out of patient management, I am hoping to curb drug development to answer such questions”.