In summary, I am designing a quality improvement project to increase guideline adherence. After taking a baseline test, I will randomize the participants into control and intervention groups based on their baseline score, so that the mean scores of the groups are comparable. Then I will educate the intervention group and do a post-experiment test in the end of the study and compare the groups.
So is this a randomized clinical trial? Can it somehow be considered a controlled before after study? And most importantly, do I absolutely need to register this study on clinicaltrials.gov for it to publishable?
Yes, it is a randomized controlled trial.
If you have a "sham"/"placebo" intervention for your designated control group, as counterpart for your educational intervention in the experimental group, then I think it can also be secondarily considered a before-after/pretest-posttest design in a technical sense. However, first and foremost your plan screams randomized controlled trial and the before-after aspect of it is more of a necessity to contextually achieve your randomized controlled trial design. Thus, in my view, it is better to present your protocol as that for a randomized controlled trial.
Yes, please register your protocol to clinicaltrials.gov (or any other trial protocol registry if you like) so future readers of your eventual publication can check your adherence/deviation to the original protocol design, as this will have impact on the quality of the evidence you will present.
It is better to register your protocol in clinical trial.gov, so other researchers can follow your project and be aware of it.
1. Please do register it at clinical trials.gov in any case
2. Because you are not adding any placebo, it's better to change the design to "quassi experimental"
3. If you don't want to change the design to quassi experimental, then you may consider changing it to "crossover trial"
Hi,
The definition of a clinical trial is "Clinical trials are research studies performed in people that are aimed at evaluating a medical, surgical, or behavioral intervention."
The proposed study is a behavioral intervention and it is a clinical trial needing registration.
Hello Ali
i agree with the others related to the study design you present. However is an RCT the correct approach for a quality improvement project that applies evidence-based guidelines? Why do you need to test this guideline if it is a standard of practice? And why would you not make it available to all participants?
Caution, colleagues: the requirement under U.S. Law to register a study has to do with evaluations of FDA-regulated products. If a randomized trial is a behavioral intervention that's tied to guideline adherence, the study design may not be suitable for product evaluation. And, if the researcher is not working on behalf of a marketing authorization holder, there's no way to tie study results to a product, and the subsequent "results reporting" required for a registered study is impossible. I urge this colleague NOT to register on clinicaltrials.gov, but to Andres' point, to register the study via ICTRP (managed by the World Health Organization), or another such source, to inform other researchers.
Yes, it is. If you intend to submit the updated products to Japanese Authority (PMDA), you must prepare the submission files including the study report of clinical trial, which may be used the results obtained out of Japan. But before that, you must have the meeting with PMDA on the reason for the quality improvement and positing of the updated product, etc. In addition you will be discuss the contents of clinical trial protocol along with CMC quality (?).
- Badges
- Science topic
- Similar topics
- Comment