All Times EDT
Keywords: Q-TWiST, Toxicity, Relapse, Risk, Benefit, utility weights
The primary endpoint in oncology clinical trials is often time-to-event endpoint, where comparative analysis is done with the median time, the point at which 50% of the subjects have had the event.
In these studies, safety is assessed as incidence rates of adverse events (ie. number of subjects with toxicity) as well as summarizing the maximal severity grade for each subject observed over the treatment period.
Both analysis methods do not take into account the long-term complications of varying severity among subjects alive without accounting for relapse.
Therefore, to complement efficacy and safety data reported in clinical trials, Quality-adjusted Time Without Symptoms or Toxicity (Q-TWiST) analysis is used to assess the balance of risk (toxicity) and benefit (prolonged survival without symptoms of progression or adverse events) of oncology treatments.
Q-TWiST is gaining acceptance as an alternative QALY (quality-adjusted life-year) method that incorporates both the benefits and risks of drug effect, capturing toxicity and mortality effects of treatment observed over the follow-up duration of a clinical trial.
Data from Q-TWiST analysis using fixed utility weights and utility weights associated with clinical trials will be evaluated.