Dr. Harriet Sommer Receives Paul Martini Award for STAT-Net Publications

Dr. Harriet Sommer is a mathematician who joined the team of Prof. Martin Schumacher at the Institute of Medical Biometry and Statistics in Freiburg in 2011. From 2013 to 2018 she worked together with Prof. Martin Wolkewitz in STAT-Net, the methodological “think tank” of COMBACTE-NET, and later on also joined COMBACTE-MAGNET‘s WP3B. Harriet received a Paul Martini Award for three COMBACTE STAT-Net publications, as well as her doctorate thesis.

STAT-Net is inter alia evaluating novel clinical trial design strategies based on modern biostatistical and epidemiological concepts aimed to increase efficiency and success rates of clinical trials. The team in Freiburg develops more informative analysis techniques of complex time-to-event patterns and improves the accuracy of endpoints in severe infectious diseases.

In previous randomized controlled trials, different primary endpoints have been used and treatment effects are mostly assessed at the end of follow-up which varies between studies. Moreover, recommendations given by the existing guidelines are not consistent. Harriet proposed a “cure-death” model combining two standard measures of clinical benefit that are highly relevant from the patients’ perspective. More precisely, it allows the evaluation of the endpoint “get cured and stay alive over time” to understand the underlying mechanisms of the treated agents assessing the entire follow-up period with cure and death as co-primary endpoints.

She received the Paul-Martini Award of the German Association for Medical Informatics, Biometry and Epidemiology (GMDS) for her doctoral thesis (download below) and the publications:

• Sommer H et al., Pharm Stat. 2017 Jul;16(4):267-279
• Sommer H et al., N Engl J Med. 2017 Apr 20;376(16):1594
• Sommer H et al., Antimicrob Agents Chemother. 2017 Dec 21;62(1). pii: e01691-17

It aims at appreciating the development of excellent methodology in clinical trial research for the evaluation of therapeutic measures in the year 2018. The prize is endowed with € 2,500 and was presented during the 63rd GMDS Annual Meeting 2018 in Osnabrück. More information can be found here.

Harriet is now working at Roche Pharma AG near Basel where she is currently involved in the early benefit assessment process of inter alia cancer immunotherapy drugs. The early benefit assessment of drugs was introduced in Germany in 2011 with the AMNOG (Arzneimittelmarktneuordnungsgesetz). If new drugs are placed on the market in Germany after marketing approval, they are also reimbursed by the health insurance funds. The AMNOG regulations provide that new drugs are compared to an appropriate comparative therapy in a so-called value dossier that must be submitted to the Federal Joint Committee (G-BA). This serves as basis for later price negotiations with the health insurance funds.

During the time she worked in STAT-Net, Harriet Sommer (co-)authored a number of fundamental publications on behalf of COMBACTE:

Optimizing the Design and Analysis of Clinical Trials for Antibacterials Against Multidrug-resistant Organisms: A White Paper From COMBACTE’s STAT-Net
de Kraker MEA, Sommer H, de Velde F, Gravestock I, Weiss E, McAleenan A, Nikolakopoulos S, Amit O, Ashton T, Beyersmann J, Held L, Lovering AM, MacGowan AP, Mouton JW, Timsit JF, Wilson D, Wolkewitz M, Bettiol E, Dane A, Harbarth S; COMBACTE-NET Consortium.
Clin Infect Dis. 2018 Aug 13. doi: 10.1093/cid/ciy516.

The Impact of Early Adequate Treatment on Extubation and Discharge Alive of Patients With Pseudomonas aeruginosa-Related Ventilator-Associated Pneumonia
Sommer H, Timsit JF, von Cube M, Schumacher M, Darmon M, Schwebel C, Ruckly S, Wolkewitz M; COMBACTE-MAGNET Consortium.
Crit Care Med. 2018 Oct;46(10):1643-1648. doi: 10.1097/CCM.0000000000003305.

Relative risk and population-attributable fraction of ICU death caused by susceptible and resistant Pseudomonas aeruginosa ventilator-associated pneumonia: a competing risks approach to investigate the OUTCOMEREA database
von Cube MK, Timsit JF, Sommer H, Darmon M, Schwebel C, Bailly S, Souweine B, Wolkewitz M.
Intensive Care Med. 2018 Jul;44(7):1177-1179. doi: 10.1007/s00134-018-5109-9. Epub 2018 Mar 16

Bezlotoxumab and Recurrent Clostridium difficile Infection
Sommer H, Timsit JF, Wolkewitz M; COMBACTE-NET Consortium.
N Engl J Med. 2017 Apr 20;376(16):1594. doi: 10.1056/NEJMc1702531

Assessing Noninferiority in Treatment Trials for Severe Infectious Diseases: an Extension to the Entire Follow-Up Period Using a Cure-Death Multistate Model
Sommer H, Bluhmki T, Beyersmann J, Schumacher M; COMBACTE-NET and COMBACTE-MAGNET consortium.
Antimicrob Agents Chemother. 2017 Dec 21;62(1). pii: e01691-17. doi: 10.1128/AAC.01691-17. Print 2018 Jan.

The time-dependent “cure-death” model investigating two equally important endpoints simultaneously in trials treating high-risk patients with resistant pathogens
Sommer H, Wolkewitz M, Schumacher M; COMBACTE-NET consortium.
Pharm Stat. 2017 Jul;16(4):267-279. doi: 10.1002/pst.1809. Epub 2017 Jun 9.

Appropriate endpoints for evaluation of new antibiotic therapies for severe infections: a perspective from COMBACTE’s STAT-Net
Timsit JF, de Kraker MEA, Sommer H, Weiss E, Bettiol E, Wolkewitz M, Nikolakopoulos S, Wilson D, Harbarth S; COMBACTE-NET consortium.
Intensive Care Med. 2017 Jul;43(7):1002-1012. doi: 10.1007/s00134-017-4802-4. Epub 2017 May 2.

Necessity of a Competing Risk Approach in Risk Factor Analysis of Central Line-Associated Bloodstream Infection
Weber S, von Cube M, Sommer H, Wolkewitz M.
Infect Control Hosp Epidemiol. 2016 Oct;37(10):1255-7. doi: 10.1017/ice.2016.166. Epub 2016 Aug 17.