The randomized clinical trial trustworthiness crisis

Abstract

Background The rising number of retracted randomised clinical trials (RCTs) is a concern over their trustworthiness. In today’s digital landscape electronic observational data is easily accessible for research purposes. This emerging perspective, in tandem with the growing scrutiny of RCT credibility, may steer some researchers towards favouring non-randomized studies. It is crucial to emphasize the ongoing need for robust RCTs, shedding light on the areas within trial design that require enhancements and addressing existing gaps in trial execution. Main body Evidence-based medicine pivots on the nexus between empirical medical research and the theoretical and applied facets of clinical care. Healthcare systems regularly amass patient data, creating a vast reservoir of information. This facilitates large-scale observational studies, which may appear as potential substitutes for RCTs. These large-scale studies inherently possess biases that place them a notch below randomized evidence. Honest errors, data manipulation, lapses in professionalism, and methodological shortcomings tarnish the integrity of RCTs, compromising trust in trials. Research institutions, funding agencies, journal editors and other stakeholders have the responsibility to establish robust frameworks to prevent both deliberate and inadvertent mishandling of RCT design, conduct and analysis. Systematic reviews that collate robust RCTs are invaluable. They amalgamate superior evidence instrumental in improving patient outcomes via informed health policy decisions. For systematic reviews to continue to retain trust, validated integrity assessment tools must be developed and routinely applied. This way it will be possible to prevent false or untrustworthy research from becoming part of the recommendations based on the evidence. Conclusion High-quality RCTs and their systematic reviews play a crucial role in acquiring valid and reliable evidence that is instrumental in improving patient outcomes. They provide vital information on healthcare effectiveness, and their trustworthiness is key to evidence-based medicine.