I have been involved in a large number of trials and studies over my almost three decades as a researcher. In these trials I have either been the main responsible for the protocol, analysis and report; or have had major influence on design and interpretation.
Professional Experiences within Clinical Development
As Chief Scientific Officer & Head of Clinical Development at Empros Pharma, I have been responsible for design, execution, analyses and presentation of the four phase II and one phase I clinical trials
These trials ranged from a few weeks to 6 months and encompassed in total more than 600 participants [Here are links to the publications: EP-001, EP-002 (LEAAP), EP-003 (SESAM), EP-004 (COBEX and EP-005 (POEM)]
I wrote the synopsis for all trials, partook in development of key items such as protocol, the statistical analytic plan (SAP), risk management plan and pharmacovigilance plan. I also reviewed and discussed results from monitoring visits. For the POEM trial, I wrote the protocol, including the dietary counceling information, the SAP and the Clinical Trial Report.
Professional Experiences within Academia
STROKE-WALK: Patients that just had a stroke or transient ischemic attack got sms reminders to improve physical activity (Effects on walking performance and lower body strength, Potential effects on cardiometabolic risk factors and body composition)
Short sleep in Adolescents: I was co-supervisor in a project looking at the metabolic effects of shortened sleep in Adolescents (Review about short sleep and metabolism, Short sleep and Energy Balance, Short sleep and insulin sensitivity)
Extended Wakefullnes and Circadian Misalignment: Post-doc at Department of Medicine – Endocrinology, University of Chicago (Impact of sleep and sleep loss on neuroendocrine and metabolic function, Circadian misalignment and insulin resistance)
Danone-Sponsored Multicenter Sarcopenia Trial: Local PI for a clinical trial investigating if a nutritional supplement could improve strenght in patients with Sarcopenia (Effects of a nutritional supplement on measures of sarcopenia, Safety and tolerability of 6-month supplementation)
MSD-Sponsored Multicenter Sarcopenia Trial: Local PI for a clinical trial investigating if a nutritional supplement could improve strenght in patients with Sarcopenia. No scientific publication as a result of the trial.
Other sleep studies
Sleeping during the day: effects on the 24-h patterns of IGF-binding protein 1, insulin, glucose, cortisol, and growth hormone Eating and shift work – effects on habits, metabolism and performance Effects of Acutely Displaced Sleep on Testosterone
Physical activity studies
Subjective and objective assessment of physical activity – Influence of newly diagnosed exercise induced bronchoconstriction and gender Children with cerebral palsy do not achieve healthy physical activity levels Minor changes in blood lipids after 6 weeks of high-volume low- intensity physical activity Increased VLDL-TAG Turnover during and after Acute Moderate-Intensity Exercise
Additional publications can be seen found at PubMed
