Question

Safety endpoint analyses: It is just as important to consider an intention-to-treat analysis for safety outcomes as it is for the primary and secondary efficacy outcomes of a trial. (See the CONSORT guidelines on this.) However, there can be more difficulties in implementing and interpreting such an analysis for an adverse event outcome.

Adverse events are often based on patient report (e.g., nausea). Participants who are off-treatment (taken off by trial staff, or just stopped taking treatment on their own) are in general less likely to report adverse events to trial staff. (You can interpret "treatment" as either active treatment or control treatment.)

(1) Give at least two reasons why you think this may happen.
(2) Explain why this creates a problem for an intent-to-treat analysis when the adverse event is the outcome.

Answer 1

1,--an adverse event can arise from any use of the drug and from any route of administration,formulation or dose or overdose..
   --Adverse events can beging with their prior course..
2, Adverse events creates a problem the existence and nature of adverse effects(even death)can have a major impact on whether a particular intervention will be acceptable and useful..some consequence of the condition being treated..Randamised trials offers the best approach for providing safety data as well as efficacy data although they can not detect rare harms..39% had adequate reporting of clinical adverse events and 29% had adequate reporting of laboratory defined toxicity..in six general medical journals in 2006 to 2007 found that,although 89% 133 reports mentioned adverse events,no information on severe adverse events and withdrawel of patients due to an adverse event was given on 27% and 98% of articles,respectively.