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Results tagged with clinical-trials
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user 41404
Clinical trials are studies designed to test the safety and efficacy of new clinical interventions such as drugs or medical devices.
5
votes
"Pragmatic" trials: what are they?
The Schwartz & Lellouch paper mentioned by Alexis, originally published (1967) in J Chron Dis, was reprinted in 2009 in a J Clin Epi issue that took up this theme in a number of papers [1–8].
Of thes …
- 2,187
2
votes
Accepted
How to improve the efficiency of an estimator when the estimates significantly vary among su...
I agree with @user918967 that you have wrongly formulated your problem, but I believe your misformulation involves ethical as well as technical deficiencies. In particular, your focus on an 'estimator …
- 2,187
1
vote
How to compare clinical trial data to a natural history control
Eric, broadly speaking, your problem sounds severe enough that a search for off-the-shelf solutions seems misguided. Rather, you almost surely need recourse to bespoke modeling to exploit your special …
- 2,187
5
votes
Accepted
Book/resource recommendation for design and analysis of clinical trials
For a comprehensive overview properly informed by history, I recommend Stephen Senn's Statistical Issues in Drug Development, 2nd edition [1].
Senn S. Statistical Issues in Drug Development. 2nd ed. …
2
votes
Accepted
post hoc subgroup analysis
Your reference to "a certain group of patients" [emphasis mine] suggests to me that maybe you are starting with a definite hypothesis that is informed by pathophysiology or maybe observational researc …
- 2,187
3
votes
Sample size calculation for double blind placebo controlled trial
Doing pre- and post-treatment biopsies in a sham-controlled group whom you expect (by your own admission) to enjoy no benefit seems grossly unethical. You would expose the sham subjects to pain and ot …
- 2,187
3
votes
Accepted
Should I include post-treatment data from the wait-list control group in the final analyses?
You have a problem of missing data here, in which the missing-data mechanism hopelessly confounds the mechanism of the treatment effect. This likely represents a failed trial, which you should report …
- 2,187