Many study design in phase II clinical trial do not use control group (single arm), without randomization or blinding. Can we do a meta analysis for such studies?Can we do analysis comparing the initial data (before intervention) and after intervention data?Thank you for the answer
Dear Surye,
Of course you can do the meta-analysis. You can pool the mean (or percentage of) changes of a variable before and after intervention in each included study. The final pooled result would show the readers how much change with intervention we have.
I have attached one of our meta-analysis on the effect of Mozart music on epilepsy with the same approach.
Yes you can do it with effect size. The method is to use the mean difference between pre- and post-treatment on the meta-analysis. But this methodoloy is not evaluated the placebo effect. It show you not efficacy but general effects.
i am now attaching one file that using pre-post meta-analysis.
Article General effect of low-dose tamsulosin (0.2mg) as a first-lin...
It is easy (comparison within the same group)- (Pre/Post comparison)
First Group: Before intervention (PRE)
Second group: After intervention (POST)
Thank you for the answer Ramin, Sungryul, Trevor, and Ahmed. If the data I want to extract consist of mean, median (not same) for each study, what should I do?
Phase 2 trials are mainly set up to obtain early indications of efficacy and also explore the dosages and frequencies of administration in the case of a drug development. they also focus on safety and tolerability. they are often randomized but that may not always be the case since the decision to randomize may be based on both the disease on interest and the intervention to be used.
Phase II trials are seldom fully powered for effect as the focus is on gaining sufficient evidence to justify the investment in Phase III trials.
however meta analysis is possible in some cases but the interpretation of your results is where the real issues begin with several types of bias coming into play as the others have suggested in their answers. caution is the rule of thumb.
here is a link to an open access article you could look at:
http://www.trialsjournal.com/content/15/1/346
You can find some information at the cochrane handbook (Cochrane Handbook for Systematic Reviews of Interventions) -Chapter 13: Non-randomized studies.
http://www.cochrane.org/handbook
Good luck
Dear Surya,
You can still pool the mean of a variable in different studies if you have mean, SD, and sample size of each variable.
Hello there,
Yes it can be performed. The primary goal of phase 2 trials is to identify therapies that warrant further investigation based upon acceptable toxicity and promising efficacy. Additional purposes include assessing feasibility (logistics and costs) and acquiring further pharmacological information. Most phase 2 publications report insufficient detail on the statistical design of the trial. Information is often limited regarding rationale for expected outcomes, identification of comparison groups, and reporting of power and type I error. Phase 2 trials may be subject to bias in interpretation of analyses, particularly when subset or post-hoc analysis is performed. These should be interpreted with caution by the user, since the general study design is subject to bias in the selection of patients that may affect such subset analyses. Similarly, as in any study it is important that users carefully consider any differences between patients enrolled to the trial and those evaluated for results. Do keep this in mind and proceed.
Hope this helps
Regards
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