Study design

When writing the Protocol it is important that you consider the study design carefully. Deciding on the appropriate design will depend on the nature of your intervention and the objectives and endpoints of your study. The type of design chosen will also have important implications for your required sample size, study population and statistical analyses. This has in turn will be important for calculating recruitment times and budget planning for your study.

Useful resources:
1. The Trial Protocol Tool has a very useful section on study design and outcome measures: http://www.globalhealthtrials.org/articles/trial-protocol-tool/
2. Presentation on study design and protocol development: http://videocast.nih.gov/ppt/NIAID_clinical_041505.ppt
3. Article on study design and statistics for beginners:
http://williampcoleman.wordpress.com/2007/11/14/clinical-trial-design-for-beginners/
4. http://www.globalhealthtrials.org/community/blog/post/hsosa/2010/08/adaptive-clinical-trial-design/
5. http://www.globalhealthtrials.org/community/blog/post/naveedbhutto/2010/08/step-wedge-design-randomized-trial/
6. http://www.globalhealthtrials.org/community/blog/post/mosesalobo/2010/05/itt-intention-to-treat-the-elephant-in-the-room/

To return to the Global Health Research Process Map click the following link:
https://processmap.tghn.org/

Please use the comment box to explain any problems that you have with this process step or any solutions that you have found to make this step easier for others. If you have any suggestions for additional resources or guidance, please provide these below.

The information posted in this group may be used for research purposes. If you would prefer your comments not to be used for research purposes please state this when commenting.

Reply

  • fridao Frida OYAKHIROMEN 22 Jun 2011

    thank you dear Lawrence for this article. do you have the outcome of this study yet? and if yes, should the outcome be that the second arm with additional motivational text messages responded better, what is the plan of the investigator to put his findings into recommendation or application?

  • fridao Frida OYAKHIROMEN 22 Jun 2011

    Thank you dear Lawrence for sharing this study with us. Do you have the outcome of the study yet? And if the finding was that the second arm (with additional motivational text messages) responded better, what is the investigator planning to do in term of recommendation or implementation to translate his findings into a practical solution for patients under HIV standard care???

  • fridao Frida OYAKHIROMEN 1 Jul 2011

    Dear Lawrence do you have the result of this study? Should the outcome be that the arm with additional motivational text messages show a better adherence to their treatment, how does the investigator plan to implement this into real life? through which means and with which budget?????

Please Sign in (or Register) to view further.