Design and Conduct of research and clinical trials

Griffiths, Gareth, Byrne, Anthony, Hood, Kerry and Maughan, Timothy S. (2008) Design and Conduct of research and clinical trials. In, Walsh, Declan (ed.) Palliative Medicine. Mosby, pp. 148-156.

Abstract

Key points:
* The clinical impact of research evidence relies on confidence in its quality.
* Palliative care is characterized by complex clinical situations, but clinical trials require simple clinical questions.
* The designs of explanatory and pragmatic trials depend on the clinical research question.
* Choices of study populations and standard comparators influence the generalizability of the results (i.e., external validity).
* An adequate sample size and low attrition rate influence the reliability of the study result (i.e., internal validity).
* Randomization reduces the risk of bias by overcoming confounding factors.
* Choices of clinically relevant outcome measures and patient populations are crucial for the relevance of palliative care clinical trials.
* Qualitative and other important clinical information can be included in the design of quantitative clinical trails.
* Infrastructural support is essential for adequate recruitment, data management, and research governance.

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Contributors

Author: Gareth Griffiths

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