Risk of Polio clinical trial failure

How can we estimate the risk of a Polio clinical trial from the protocol?

The global health community has made significant strides in the fight against polio, a highly infectious disease that mostly affects young children and can cause severe paralysis, and in some cases, death. Thanks to the establishment of the Global Polio Eradication Initiative (GPEI) in 1988 and subsequent widespread immunization efforts, the incidence of wild poliovirus has decreased dramatically. However, the effort to completely eradicate the disease has been an uphill task, facing multiple challenges related to clinical trials’ informativeness.

The success of a clinical trial is often based on its ‘informativeness’, defined by its ability to guide clinical, policy, or research decisions. However, an alarming proportion of these trials do not necessarily meet the required conditions for informativeness. A study by Hutchinson et al (2022) found that only 26.4% of the observed clinical trials met these conditions, posing a significant risk to the eradication efforts.

A clinical trial’s protocol is an essential determinant of its success or failure, and hence, the informativeness of the same. A poorly designed or executed protocol can significantly affect the outcome of the trial; similarly, the absence of a comprehensive Statistical Analysis Plan (SAP) in a trial is a serious risk.

Fast Data Science’s Clinical Trial Risk Tool aims to address this very challenge by predicting the risk associated with a clinical trial based on its protocol. The tool uses machine learning to evaluate protocol-related parameters and determine the success likelihood of a trial from its early stages.

Based on an extensive analysis of various trial parameters such as number of participants, duration, uncontrolled variables, and exposure control, this advanced tool utilizes intricate algorithms to calculate risk factors that might affect a trial’s outcome. With this predictive tool, it’s possible to make an a priori assessment of the potential informativeness of a trial, thus enhancing the success chances of polio eradication.

In conclusion, while the risk of failure in Polio clinical trials is indeed a disruptive issue in the eradication efforts, predictive tools like Fast Data Science’s Clinical Trial Risk Tool are drastically revolutionizing the planning and execution of these trials. By robustly assessing the trial protocols for possible risks, we increase the likelihood of informative and successful clinical trials in our enduring fight against Polio.

References

Other clinical trial risk, cost, informativeness, and complexity assessments