The impact of research waste on the scientific validity and integrity of clinical trials
The impact of research waste on the scientific validity and integrity of clinical trials

Summary/Abstract: Despite advancements in medicine and research methodology as well as enormous financial investments, many clinical trials do not provide the expected results, which is to deliver new, safe and effective drugs on the market. While this may stem from the poor performance of the tested treatment, many failures in clinical trials may be due to flaws in their design, conduct, and data analysis. Together with misconduct, non-reporting, and publication bias, this amounts to research waste that has a negative impact on the scientific validity and integrity of clinical trials. These flaws may endanger the wellbeing of trial participants. This article provides an overview of different sources of research waste in clinical trials, with a special focus on early phase trials that enroll paediatric participants. Finally, hallmarks of wasteful trials identifiable at the stage of Ethics Committee assessment are discussed. The article proposes solutions that may reduce the negative effects of research waste, strengthening the scientific validity and integrity of new clinical trials.

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