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Panagiotis Milothridis (M.D., M.Sc., Ph.D.) is a plastic surgeon with his own practices in Thessaloniki and on the island of Chios. He received his doctorate from the Aristotle University of Thessaloniki, on the subject of psychosocial profiles of candidates for cosmetic surgery, in 2018. He received a scholarship from the European Societies of Plastic, Reconstructive Surgery (ESPRAS) and the Dutch Aesthetic Facial Plastic Reconstructive Surgery (DAFPRS) and in 2018 completed a 3-month scholarship in Rhinoplasty in Istanbul, Turkey. In addition to his medical degree, Dr. Milothridis holds two master s degrees: in Medical Research Methodology and Medical Law. In addition to his work as an aesthetic surgeon, humanitarian service is a cornerstone of his practice. He performs reconstructive surgery and treats cleft lips and palates in children around the world with limited medical and financial resources. He has worked for Doctors Without Borders (MSF) and has been an active v ....
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External Controls (Part II): Informed Choices Amidst A Portfolio Of Options William L. Slone, Ph.D., Assistant Director, Clinical Research Methodology; Melissa Vadnais, VMD, Ph. D., Clinical Trial Methodology Fellow; Andrew Kuhlman, Medical Writer; Michael F. Murphy, MD, Ph. D., Chief Medical & Scientific Officer As discussed in Part 1 of this series (EXTERNAL CONTROLS IN CLINICAL RESEARCH (PART I): THE CLINICAL IMPERATIVE), regulatory concepts referable to the creation of an external control group have long been noted and occasionally implemented, particularly for diseases with severe morbidity, mortality, and unmet medical need. As defined in Guidance for Industry: E10 Choice of Control Group and Related Issues in Clinical Trials (2001), “an externally controlled trial is one in which the control group consists of patients who are not part of the same randomized study as the group receiving the investigational agent.” ....