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Die richtige Rekrutierung von Studienteilnehmern

Patient recruitment in clinical studies

  • Leitthema
  • Published:
Bundesgesundheitsblatt - Gesundheitsforschung - Gesundheitsschutz Aims and scope

Zusammenfassung

Die Rekrutierung von Patienten in klinische Studien ist ein essenzieller früher Schritt in jeder Arzneimittelstudie. Die Qualität dieses Prozesses ist mitbestimmend für die Sicherheit der gesamten Studie und beeinflusst den wissenschaftlichen Erkenntnisgewinn. Eine zeitnahe Rekrutierung der Studienteilnehmer ist einerseits wichtig für den Entwicklungsprozess der Arzneimittel und aus gesellschaftlicher Sicht wünschenswert. Andererseits dürfen Geschwindigkeit und Eile nicht die Gesundheit der Teilnehmer gefährden. Aus diesem Grund müssen alle Teilschritte einer Rekrutierung, angefangen bei der Identifizierung der Teilnehmer über deren Erreichbarkeit und Information bis zum erfolgreichen Studieneinschluss, entsprechend optimiert erfolgen. Der vorliegende Beitrag beschreibt die zahlreichen Herausforderungen in der Rekrutierung, Fallstricke und Risiken, die eine sichere und erfolgreiche Rekrutierung gefährden, sowie Strategien zur Verbesserung dieses wichtigen Prozesses.

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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  1. Abteilung Innere Medizin VI, Klinische Pharmakologie und Pharmakoepidemiologie, Universitätsklinikum Heidelberg, Im Neuenheimer Feld 410, 69120, Heidelberg, Deutschland

    B. Grün &  W.E. Haefeli

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  1. B. Grün
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  2. W.E. Haefeli
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Correspondence to W.E. Haefeli.

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Grün, B., Haefeli, W. Die richtige Rekrutierung von Studienteilnehmern. Bundesgesundheitsbl. 52, 402–409 (2009). https://doi.org/10.1007/s00103-009-0822-8

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  • DOI: https://doi.org/10.1007/s00103-009-0822-8

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