Nature: In a review of clinical trials, 44% contained flawed data and 26% could not be trusted, researcher finds
Artem Andrianov, PhD
CEO & Founder | RBQM Solutions in Clinical Trials | eMBA | Author | Keynote Speaker
In a world where the trustworthiness of clinical trials is under scrutiny, could the key to restoring faith in medical research lie in the power of data sharing?
The integrity of clinical trials is a cornerstone of medical research. However, as highlighted by Richard Van Noorden in his article at Nature (1), a significant proportion of published studies may be flawed or even entirely fabricated. This issue has far-reaching implications, potentially skewing the results of systematic reviews and meta-analyses, misguiding medical practices, and compromising patient care. One proposed solution to enhance the trustworthiness of clinical trials is the routine sharing of Individual Participant Data (IPD). So what are the potential benefits and challenges of this approach?
The Current Landscape
Van Noorden underscores the alarming prevalence of 'zombie' trials - studies that appear legitimate but are based on flawed or fabricated data. Anaesthetist John Carlisle found that 44% of the trials he reviewed contained flawed data, and 26% were so problematic that they could not be trusted. The issue extends beyond individual fakers, with entire fields potentially plagued by unreliable trials.
The Case for Data Sharing
One of the key findings in Van Noorden's point is the stark difference in the detection of flawed data when Carlisle had access to IPD compared to when he could only study aggregated information. In the former case, he found that 44% of trials contained flawed data, while in the latter, only 2% were identified as flawed. This discrepancy underscores the potential value of data sharing in enhancing the trustworthiness of clinical trials.
By providing access to IPD, researchers and reviewers can conduct more thorough analyses, identify inconsistencies or errors, and verify the validity of the results. This transparency could deter potential fabrications, as the risk of detection would be significantly higher.
Challenges and Concerns
While the benefits of data sharing are clear, implementing it as a routine practice is not without challenges. One of the main concerns is the protection of participant privacy. Ensuring that data is anonymized and that sharing complies with data protection regulations is crucial.
Another challenge is the potential burden on researchers and reviewers. Collecting, managing, and sharing large datasets can be time-consuming and resource-intensive. Reviewers, too, would need to invest additional time in scrutinizing IPD, potentially slowing down the review process.
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Moving Forward
Despite these challenges, the potential benefits of data sharing in enhancing the trustworthiness of clinical trials are significant. As Van Noorden's article suggests, the current trust placed in the integrity of clinical trials may be misplaced, with serious implications for medical research and patient care.
To address these issues, journals, funding bodies, and research institutions need to work together to develop robust data-sharing policies and provide the necessary resources and support. This could include developing secure data repositories (2), providing training in data management, and recognizing the additional work involved in data sharing in the review process.
Conclusion
The issue of untrustworthy clinical trials is a serious concern that threatens the integrity of medical research. Data sharing offers a promising solution, allowing for greater transparency and scrutiny of trial data. While challenges exist, the potential benefits for research integrity and patient care make it an imperative worth pursuing. As the medical research community continues to grapple with this issue, the words of John Carlisle resonate: "The solution's got to be fixed at the source." Data sharing could be a crucial part of that fix.
References
2. Bunschoten L. Enhancing Clinical Trial Risk Management: A Response to the Growing Concerns over Fraudulent Studies. Accessed July 24, 2023. https://cyntegrity.com/clinical-trial-integrity-risk-management/undefined
Clinical Research Consultant @ Self-employed | PhD, CCRA, ACRP-PM, MICR
1 年Sharing the data is one thing, ensuring data integrity and ethical data management procedures is another. Why not educate new researchers via their medical curriculum, governmental programmes? I am also convinced that an independent data monitoring process during the trial's conduct can add significantly to its quality of data. However, data management usually happens after the data are clean and the database closed.