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A Clinical Trial Assessing the Safety, Efficacy, and Delivery of Olive-Oil-Based Three-Chamber Bags for Parenteral Nutrition
Published on: September 20, 2019
[Patient recruitment in clinical studies]
1Abteilung Innere Medizin VI, Klinische Pharmakologie und Pharmakoepidemiologie, Universitätsklinikum Heidelberg, Im Neuenheimer Feld 410, 69120, Heidelberg.
Abstract:
Patient recruitment in clinical studies is an essential step early in a drug trial. The quality of this process determines the safety of the trial and may modulate the validity of the resulting scientific information. While there are good reasons to recruit participants as quickly as possible to accelerate drug development and promote new treatment options, it is even more important to safeguard health and well-being of the participant. Therefore all steps of recruitment from patient identification and patient availability to patient information and enrolment have to be tailored accordingly. This paper describes the numerous challenges in this task, pitfalls and risks that may jeopardize reliable and effective recruitment, and strategies to improve this important process.
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