I am currently designing a questionnaire for an RCT treatment on cancer therapy. The questionnaire is planned to be administered at the end of each cycle to aks patients about any health care resources use outside the clinical trial. However, patients may withdraw from the trial at any time for any other reason. I need your advice if it would be value-adding to collect data from a patient who withdraw from the trail before the schedule data collection points before the end of each cycle of treatment. These patients usually visit the trial and conduct or the other planned end of trial procedures.
The manner by which your stated plan adds value to your study really depends on your team's planned objectives and the soundness of the rationale for the said intention. Based on the information that you gave, my general instinct is to "let her/him go" from further involvement in the study if the subject declares her/his withdrawal or simply becomes lost to follow-up. I foresee that you would even need to clarify this aspect in your informed consent. If the scenario you are anticipating is that you can still get in touch with the withdrawing patient(s), they consent for further questioning even if they do not wish to participate in the main activities of the RCT, and the goal of the health care resource data gathering is sound (e.g., to assess why subjects withdrew from the study and to determine relevant differences in resource utilization, among others), then you should strongly consider this plan. Take note, however, that this is somewhat unusual as far as study designs are concerned, as withdrawal from the main part of the study is usually interpreted to mean withdrawal from all aspects of the study.
I see. Then I guess it really makes sense for your team to pursue the subjects withdrawing from the RCT for the health economic analysis component of your endeavor. Good luck!
There are two types of analysis done with the available data, without adding any additional information.
Per protocol analysis; analyzing all compiled subjects for all cycles.
Intention to treat ana. : missing values are imputed with mean of the group or previous values are carried forward.
We cannot include any external data against the protocol.
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