An international team of researchers has introduced a groundbreaking tool known as INSPECT-SR that aims to pinpoint problematic randomized controlled trials (RCTs), including those with fraudulent data or serious concerns regarding trustworthiness.
The finalized version of INSPECT-SR has been officially published on the preprint server medRxiv. This innovative tool was developed by a consortium of over 150 integrity and health research experts, spearheaded by Dr. Jack Wilkinson from The University of Manchester, in collaboration with the University of Colorado Anschutz Medical Campus and Cochrane, a prominent not-for-profit organization renowned for publishing health systematic reviews.
The rise in questionable high-level summaries of research evidence from randomized controlled trials, also known as systematic reviews, has raised significant concerns within the scientific community. Some of these studies may contain critical errors, while others are suspected to be fraudulent. Shockingly, in 2023 alone, more than 10,000 research papers globally were retracted by journals, many of which relied on evidence from problematic RCTs.
Dr. Wilkinson emphasizes that problematic RCTs can have far-reaching consequences, potentially compromising medical research, impeding drug development, and jeopardizing promising academic endeavors.
INSPECT-SR is specifically designed to identify problematic RCTs that may feature falsified or manipulated data or unintentional critical errors. By guiding users through a series of 21 checks across four key domains, the tool helps to systematically evaluate the trustworthiness of these trials.
One notable example of problematic RCTs involved claims surrounding the efficacy of the drug Ivermectin in treating severe COVID-19 cases. Several trials supporting these claims were later revealed to be fabricated, leading health authorities in the U.S., U.K., and EU to question their validity. Subsequent high-quality trials cast doubt on the supposed benefits of Ivermectin.
Similarly, the recommendation for a device called a fetal pillow, intended to aid cesarean sections, was reversed by the National Institute for Health and Care Excellence (NICE) following the retraction of three clinical studies supporting its use. A detailed analysis in BJOG: An International Journal of Obstetrics & Gynaecology highlighted statistical anomalies in these studies that may have been flagged by a trustworthiness assessment.
Furthermore, a group of trials examining the effectiveness of cognitive-behavioral therapy (CBT) and exercise for managing spinal pain raised trustworthiness concerns. Several of these trials, which significantly impacted clinical guidelines, have since been retracted.
Dr. Wilkinson underscores the importance of ensuring the genuine nature of evidence included in systematic reviews to avoid the inadvertent inclusion of fraudulent or flawed studies. INSPECT-SR is poised to become the standard for assessing the trustworthiness of RCTs, particularly in the context of Cochrane’s systematic reviews of health interventions.
As research progresses, efforts are underway to develop automated systems, potentially leveraging artificial intelligence (AI), to enhance the identification of problematic studies in various research domains. The ultimate goal is to safeguard the integrity of scientific literature and prevent misleading or harmful research from influencing critical healthcare decisions.
For more information on INSPECT-SR and its impact on evaluating the trustworthiness of randomized controlled trials, refer to the published study on medRxiv. This groundbreaking tool has the potential to revolutionize the identification of problematic research studies, ultimately fortifying the foundation of evidence-based healthcare practices.
