In this E-Learning module, the author emphasizes that most large randomised clinical trials are funded by commercial sponsors. Therefore, oncologists should have a critical, but constructive mindset when reading reports and observing presentations of results of clinical trials. They should lobby regulatory agencies to approve new treatments based on clinical benefit rather than statistical significance.
The author encourages oncologists, when analyzing/interpreting clinical trial results, to ask themselves questions such as:
- is the control group appropriate
- are the outcome measures (endpoints) appropriate
- is toxicity evaluated comprehensively
- are the outcomes of clinical value and not just statistically significant
- do related trials give consistent results
- does the report of the study reflect its results
- are the results likely to apply to patients who present in everyday clinics.
The author emphasizes that there are excellent practice-changing trials that compare different strategies. However, some other trials have not been designed, analyzed and reported with the same rigour. Each of the relevant questions stated above is illustrated by examples from particular clinical trials.
A range of different problems is elaborated in this module, including a bias in the reporting of endpoints of efficacy and toxicity in randomised clinical trials, the missing voice of patients in drug safety reporting, and that honourary and ghost authorship are common.
The author suggests that the reporting of clinical trial results could be improved if reviewers were provided with a checklist of simple questions, such as whether the primary endpoint is appropriate and defined explicitly, if the main conclusion applies only to that primary endpoint, if toxicity is described adequately, if analysis of subgroups is pre-planned and exploratory, and if the report is free of spin and bias. The editors should verify that these questions are addressed, at least for the abstract.
This E-learning module is excellent teaching material authored by an experienced oncologist with a recognised career path in respecting the highest ethical standards for conducting and reporting clinical cancer research.
The views expressed represent the author’s own opinions and serve the purpose of stimulating scientific exchange of ideas on the subject.
