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Related Experiment Videos

Tutorial reduces protocol deviations in multicenter ACTG trials with pharmacology endpoints.

Robin DiFrancesco1, Susan L Rosenkranz, Jean Craft

  • 1Department of Pharmacy Practice, University at Buffalo, Buffalo, New York 14260, USA.

HIV Clinical Trials
|October 27, 2006
PubMed
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A clinical pharmacology tutorial improved data accuracy for AIDS Clinical Trials Group (ACTG) research staff. This enhanced the quality of data collected in ACTG pharmacology protocols.

Area of Science:

  • Clinical Pharmacology
  • Clinical Research
  • Quality Assurance

Background:

  • The AIDS Clinical Trials Group (ACTG) requires clinical research staff to meet specific competencies in pharmacology research.
  • A quality assurance program was implemented to ensure accurate data collection in ACTG pharmacology protocols.

Purpose of the Study:

  • To develop and implement a tutorial aimed at enhancing the accuracy and completeness of data gathered in ACTG pharmacology protocols.
  • To improve the overall quality of clinical pharmacology research conducted within the ACTG network.

Main Methods:

  • Clinical research staff accessed a web-based tutorial focusing on pharmacokinetic study concepts.
  • The tutorial used comparative examples of poor versus perfect study conduct to highlight data quality's impact.

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  • A retrospective audit of case report forms and laboratory data assessed pre- and post-tutorial error rates.

    • Main Results:

    • Over two years, 236 nurses at 64 sites completed the tutorial.
    • Errors in dosing and/or sampling at visits decreased from 13% to 4%.
    • Errors in sample collection decreased from 6% to 3%, with discrepancies in recording sample times dropping significantly from 3% to under 1%.

    Conclusions:

    • The ACTG clinical pharmacology tutorial effectively improved the accuracy of protocol conduct.
    • The program demonstrated a significant positive impact on data collection quality for pharmacology objectives.