FDLI Monograph Series
Volume 1, Number 3
Reviewing Clinical Trials and Observational Studies: A Practical Guide to Assessing Scientific Validity and Causal Leverage
Lance Shea, Fulbright & Jaworski L.L.P.
Greg Burkhart, Former FDA Team Leader
Preview Volume 1, Number 3
Included in the preview:
Table of Contents, About this Monograph and the first page of every chapter
About This Monograph
How strong is the evidence supporting approval of a new drug? How much attention is warranted by the safety signal mentioned in a published medical article? What weight of evidence should be accorded a postmarketing study conducted in a healthcare database? These and many other questions are often posed to professionals in healthcare related professions.
This monograph introduces methods for assessing the credible proof of a causal relationship provided by a study or group of studies. It is written for professionals who review studies of medical products in their work but are not experts in research design, conduct or interpretation. It does not assume substantial grounding in research design or statistics. Instead, it uses non-technical language to present points to consider when assessing whether study results are valid evidence of causation or merely suggest that causation might exist. Read more in the preview.
As an aid to readers, an extensive glossary is included. Also, readers are directed to many additional materials that should be helpful in increasing their understanding of this important endeavor. By using this monograph, readers should become better able to:
- Identify the type of studies being reviewed;
- Identify the research question posed by each study;
- Identify the studies’ results and interpret accompanying statistical measures;
- Assess the causal leverage provided by the studies.
Learn more about:
- FDLI Monograph Series
- Monograph Volume 1, Number 1
- Monograph Volume 1, Number 2
- Monograph Volume 1, Number 4
- Monograph Volume 1, Number 5
- Monograph Volume 1, Number 6
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Monograph Volume 1, Number 3
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