Module 5

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Module 5

• Understanding Clinical Trial Results
• Part II
• Trainer Manual

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This teaching tool was developed by the
François-Xavier Bagnoud Center at the University
of Medicine and Dentistry of New Jersey, with the
support of the International Maternal Pediatric
and Adolescent Clinical Trials (IMPAACT) network.

• Excerpts from this publication may be reproduced
  or adapted with acknowledgement of the source,
  provided the material reproduced by and for
  non-profit distribution only.

Claire Schuster, BS, MPH Network Community
Coordinator Social Scientific Systems,
Inc. EMail cschuster_at_s-3.com [phone] ?
Version 1.0 May 2007
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Reporting study results

• Professional journals
• Scientific meetings

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Peer review

• The process of having clinical trial results
  examined and reviewed by qualified outside
  experts before the study is accepted for
  publication in a medical journal or is presented
  at a major scientific conference.

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Format for reporting study results

• Abstract
• Introduction/background
• Design and Methods
• Results
• Discussion
• This section of the training is based on a
  publication called Interpreting Medical
  Research in the Bulletin of Experimental
  Treatments for AIDS(BETA), Winter 2006.
  http//www.sfaf.org/beta

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Abstract

• Short summary of the research and the results
  obtained, including how the results might
  influence clinical care and future research.

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Introduction or background

• Background Summary of the problem or issue to
  be investigated, reason for the study
• Hypothesis the theory on which the researchers
  based the clinical trial.

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Statistically significant
Experimental (Vaccine ARV) Group
Result
Study Sample
R
VS.
Control (ARV) Group
Result
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Design and methods

• Design and implementation
• Design example This was a Phase II, parallel,
  randomized, controlled study. Perinatally
  HIV-infected infants were assigned to treatment
  with NVP-based HAART vs. HAART with a protease
  inhibitor. Two groups of infants were enrolled
  those who had been exposed to NVP perinatally, or
  those who had not been exposed to NVP.

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Results

• The publication of clinical trial results will
  include
• in-depth description of data collected
• results of the statistical analysis

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Discussion

• Interpretation of the study results
• Importance of the findings
• Problems or limitations of the study
• Future research needed
• Discussion This study confirmed our hypothesis
  that treatment with a NVP- based regimen is
  equivalent to treatment with a PI-based regimen
  in infants exposed or not exposed to NVP
  perinatally. This is important for clinical
  practice in that.

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Lay Summary

• Good news! IMPAACT protocol teams must write a
  lay summary of the study results. The lay
  summary describes the study and results but is
  written in language a non-scientist can
  understand.

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Summary

• Peer review is a process that helps to ensure
  publications are of high quality and meet
  rigorous scientific standards.
• Not all publications are peer-reviewed
• Clinical trial publications are nearly always
  written in the same basic format
• IMPAACT provides the community with a lay summary
  of trial results. There are some websites that
  also provide this service (see next slide).

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Websites that summarize HIV clinical research
findings

• http//www.WomenChildrenHIV.org
• http//sfaf.org/beta
• http//hivinsite.ucsf.edu
• http//www.thewellproject.org/en_US
• http//www.who.int/reproductive-health/stis/mtct/m
  onthly_publications/listing_mtct_reports.htm