Hello all,
In a clinical trial, a subject is assigned to the new intervention group. The device is a topical cream. During the application, something goes wrong, and the doctor decides to stop using it (for example, the wound appears to be too big), and to use standard of care instead (for example, sutures). Since the cream touched the body, this subject has to be included in the safety analysis set. What about the efficacy set? The treatment wasn't completed, for reasons not related to the treatment itself. Should this subject be treated as a missing value? What if the failure is related to the application of the specific treatment ? Still, there was a problem and a SOC was used instead (the cream wasn't applied). Can it be used as missing value? It feels unjustified to label it as failure, we don't know it failed, it will never applied.
Thank you in advance.
This could be a case of screen failure , as the patient is not amenable to either arm of the trial in the first place. If standard care can only be used, this subject is not suitable for randomisation. If problems started later in the study, what went wrong would be considered an adverse event and the details reported as such. If it is a randomised trial that allows study arm crossovers, patient could cross over to the standard therapy arm, but still continue in the study. The primary endpoints determined in the study also may be important to consider.
It is not justified to label the particular case as a failure. For a crossover design it requires a washout period after the subject has been exposed to a particular treatment arm. In this case, during the application, something has gone wrong, and the doctor decides to stop using the new intervention, so it can be included in the Safety analysis.Finally, you can do a sensitivity analysis if it is a Randomized Clinical Trial.
Yes. It should be included in the Intention to treat analysis (ITT). Also a per-protocol analysis and finally a sensitivity analysis will be very useful.
I couldn't ascertain if what you mentioned is a hypothetical scenario or an actual one. Assuming this as actual, it is not clear what was the actual intended purpose of the interventional cream, whether the inclusion/ exclusion considers wound characteristics, placebo use. if the subject was enrolled and then conditions progressed on the day of treatment , then it should be reported as an adverse event. If subject is removed from study and placed in standard of care treatment then since you applied the cream you want to know the efficacy is not a good research practice but if you manage to get enough measures that could be used in a tailored statistical approach then at least you would be satisfied.
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