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...
| Main Authors: | , , , , , |
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| Format: | Article |
| Language: | English |
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SpringerOpen
2024-01-01
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| Series: | Middle East Fertility Society Journal |
| Subjects: | |
| Online Access: | https://doi.org/10.1186/s43043-023-00161-7 |
| _version_ | 1827388779421237248 |
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| author | Furqan A. Butt Mohammad Fawzy Bassel H. Al Wattar Aurora Bueno-Cavanillas Khalid S. Khan Yacoub Khalaf |
| author_facet | Furqan A. Butt Mohammad Fawzy Bassel H. Al Wattar Aurora Bueno-Cavanillas Khalid S. Khan Yacoub Khalaf |
| author_sort | Furqan A. Butt |
| collection | DOAJ |
| description | 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. |
| first_indexed | 2024-03-08T16:23:54Z |
| format | Article |
| id | doaj.art-fe51c4d9248648aba7d7e1794c02d4e5 |
| institution | Directory Open Access Journal |
| issn | 2090-3251 |
| language | English |
| last_indexed | 2024-03-08T16:23:54Z |
| publishDate | 2024-01-01 |
| publisher | SpringerOpen |
| record_format | Article |
| series | Middle East Fertility Society Journal |
| spelling | doaj.art-fe51c4d9248648aba7d7e1794c02d4e52024-01-07T12:11:51ZengSpringerOpenMiddle East Fertility Society Journal2090-32512024-01-012911610.1186/s43043-023-00161-7The randomized clinical trial trustworthiness crisisFurqan A. Butt0Mohammad Fawzy1Bassel H. Al Wattar2Aurora Bueno-Cavanillas3Khalid S. Khan4Yacoub Khalaf5Department of Preventative Medicine and Public Health, University of GranadaIbnSina, Banon Amshaj and Qena IVF CentresBeginnings Assisted Conception Unit, Epsom and St Helier University HospitalsDepartment of Preventative Medicine and Public Health, University of GranadaDepartment of Preventative Medicine and Public Health, University of GranadaGuy’s & St Thomas’ Hospital Foundation TrustAbstract 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.https://doi.org/10.1186/s43043-023-00161-7Randomised clinical trialsObservational studiesEvidence-based medicineResearch integrityEvidence-based medicineClinical medicine |
| spellingShingle | Furqan A. Butt Mohammad Fawzy Bassel H. Al Wattar Aurora Bueno-Cavanillas Khalid S. Khan Yacoub Khalaf The randomized clinical trial trustworthiness crisis Middle East Fertility Society Journal Randomised clinical trials Observational studies Evidence-based medicine Research integrity Evidence-based medicine Clinical medicine |
| title | The randomized clinical trial trustworthiness crisis |
| title_full | The randomized clinical trial trustworthiness crisis |
| title_fullStr | The randomized clinical trial trustworthiness crisis |
| title_full_unstemmed | The randomized clinical trial trustworthiness crisis |
| title_short | The randomized clinical trial trustworthiness crisis |
| title_sort | randomized clinical trial trustworthiness crisis |
| topic | Randomised clinical trials Observational studies Evidence-based medicine Research integrity Evidence-based medicine Clinical medicine |
| url | https://doi.org/10.1186/s43043-023-00161-7 |
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