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Renee Stapleton 7/07/05

Developing a Phase II RCT: The effects of n-3 fatty acids on lung and systemic inflammation in patients with acute lung injury. Renee Stapleton 7/07/05. Outline. Choosing a research question and selecting study design Process of designing the trial Timeline Budget Lessons learned.

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Renee Stapleton 7/07/05

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  1. Developing a Phase II RCT:The effects of n-3 fatty acids on lung and systemic inflammation in patients with acute lung injury Renee Stapleton 7/07/05

  2. Outline • Choosing a research question and selecting study design • Process of designing the trial • Timeline • Budget • Lessons learned

  3. Choosing a Research Question • What types of clinical questions do I enjoy the most? • Supportive care mechanisms in the ICU • What methods do I want to focus on? • Obtain training as a clinical trialist • Which particular areas of ICU care need championing? • Nutritional delivery and supplementation

  4. Choosing a Research Question • Is there a means to do a small trial feasibly? • ALI “Clinical Trials Incubator Unit” (CTIU) • Under the umbrella of nutrition and ALI, are there any questions that have a high chance of offering me early success? • Fish oil in acute lung injury (ALI)

  5. Designing the Trial • CTIU established for phase II “proof of concept” trials in ALI • Details to think about • 2 arms versus 3 arms • Endpoints • Primary and secondary • Sample size calculations • Accurate pilot data? • Enough patients at Harborview alone? • Inclusion and exclusion criteria

  6. Designing the Trial • Details to think about (continued) • Intervention • Where to get the fish oil? • How to deliver it? • Dose? • Need to do independent testing of product • Do we need to submit an IND to the FDA? • Placebo • Blinding • How to successfully achieve blinding?

  7. Designing the Trial • Details to think about (continued) • Identification, enrollment, and consent of patients • Who will do it? • When? • Randomization • Who will do it? • When? • What design?

  8. Designing the Trial • Details to think about (continued) • Adverse effects • “Cointerventions” • Need to standardize other practices that may affect outcome • Collecting and managing data • How to ensure accuracy? • Missing data • Statistical analyses

  9. The Final Design 100 patients with ALI Enrollment and randomization within 48 hours of ALI diagnosis 1/3 fish oil + enteral nutrition 1/3 placebo + enteral nutrition 1/3 Oxepa® • Bronchoalveolar lavage and serum sampling at study entry and on days 5 and 10 (primary outcome is BAL IL-8) • Study drug delivered through day 10, extubation, or death • Secondary outcomes recorded for use in designing future trial

  10. Timeline • February 2004 – Idea was conceived • June 2004 – Started writing K23 • October 2004 – Submitted K23 • March 2005 – K12 funding • July 2005 – Human subjects application • January 2006 – Begin enrollment • December 2007 – End of enrollment?

  11. Budget • CTIU already pays for • Full time research nurse • Full time laboratory tech • Some laboratory support for assays • K12 pays for • My salary • Travel to national meeting • Desktop computer and software • Biostatistical consultation

  12. Budget – My Costs

  13. Lessons Learned • Start early • Designing the trial and getting funded is hard… • Rumor is that conducting and managing the trial is HARDER! • We’ll see

  14. Mmmm, sausage!

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