Risk of COVID clinical trial failure

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

One of the significant challenges we face in the fight against COVID-19 is the rapid development and testing of potential vaccines and treatments. Clinical trials promise the hope of data-driven solutions but also carry significant risks of failure, especially in terms of their ability to conclude informatively.

The risk of failure, specifically the risk of failing to conclude informatively, in this context, means that the trial may not provide the required answers to guide clinical, policy, or research decisions. Primary factors such as the number of participants, length of the trial, uncontrolled variables, and the ability to control exposure significantly influence this risk. If a trial is lacking a conclusive Statistical Analysis Plan (SAP), it is considered high-risk.

According to a study by Hutchinson et al., only 26.4% out of 125 examined clinical trials met the conditions for informativeness. Given the urgent need to find effective remedies for COVID-19, such a high rate of failure could lead to a significant waste of resources and time. Therefore, it becomes crucial to predict the potential risk of a trial beforehand using methods like machine learning, which brings us to Fast Data Science’s Clinical Trial Risk Tool.

Fast Data Science’s Clinical Trial Risk Tool uses advanced machine learning techniques to predict the risk of a clinical trial based on the protocol text. The protocol text, outlining the trial’s methodology, is fed to the tool to analyze the parameters affecting the trial’s informativeness. Learning from previous successful and unsuccessful trials, the tool predicts the potential risk associated with a new COVID-19 clinical trial.

With the surge in the number of clinical trials initiated for COVID-19 treatments, this tool can play a pivotal role in ensuring the effective utilization of resources. By providing an estimation of the trial risk upfront, the tool allows researchers to make informed decisions, tweak trial protocols if necessary, and thereby increase the trials’ chances of being informative.

In conclusion, Fast Data Science’s Clinical Trial Risk Tool leverages machine learning’s power to turn past failures and successes into valuable insights for future trials. By understanding the risk involved in each clinical trial, we can hope to hasten the global efforts in finding an effective cure for COVID-19.

References

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