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<p>Laboratories can play a critical role in the conduct of clinical trials. Management of different aspects of the clinical laboratory processes is essential and can determine the success of a trial. Activities within the laboratory process encompassing pre-analytical, analytical, and post-analytical processes ought to be thoroughly monitored. In this paper, we present an outline of approaches for sample collection, sample transport, sample storage, sample analysis, and data management, in a laboratory setting. The paper highlights that clinical trials are more likely to be completed successfully if there is rigorous adherence to organized quality management approaches in the laboratory. We also discuss the challenges encountered that include sample quality issues, equipment downtime, absence of reference ranges generated from the local population among others, and approaches implemented to overcome these. If implemented, the approaches described here are expected to improve the quality and integrity of the data produced in laboratories which in turn will contribute to successful clinical trial conduct.</p>

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Addressing laboratory challenges in clinical trials: approaches from the Clinical Diagnostic Laboratory Services at MRC/UVRI and LSHTM Uganda Research Unit

  • 期刊论文

  • 出版模式：

    开放获取

  • 发表日期：

    2026年3月19日

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  • Gloria Kakoba Ayebazibwe,
  • Charline Clarissa Kakweera Katurole,
  • Geofrey Kimbugwe,
  • Zephyrian Kamushaaga Member,
  • Dora Jocelyn Mulondo,
  • Priscilla Balungi,
  • Juliet Nsimire,
  • Esther Nabanoba,
  • Joanita Nassali,
  • Stephen Musemeza,
  • Moses Egesa,
  • Florence Nambaziira

摘要

Laboratories can play a critical role in the conduct of clinical trials. Management of different aspects of the clinical laboratory processes is essential and can determine the success of a trial. Activities within the laboratory process encompassing pre-analytical, analytical, and post-analytical processes ought to be thoroughly monitored. In this paper, we present an outline of approaches for sample collection, sample transport, sample storage, sample analysis, and data management, in a laboratory setting. The paper highlights that clinical trials are more likely to be completed successfully if there is rigorous adherence to organized quality management approaches in the laboratory. We also discuss the challenges encountered that include sample quality issues, equipment downtime, absence of reference ranges generated from the local population among others, and approaches implemented to overcome these. If implemented, the approaches described here are expected to improve the quality and integrity of the data produced in laboratories which in turn will contribute to successful clinical trial conduct.