The critical need for all trial sponsors today is the access to information in real time. Should we proceed? Should we terminate? Could this subject be at risk from the combination of the IP and a concomitant medication? Could the trial be at risk from fraud at a particular site or from a randomization error? All too often, the answers come too late, when there is nothing to do but abort – course correction is no longer an option. The site is closed, the subject is deceased or the trial has run its course and billions of dollars have been wasted in an investment with no returns.
The traditional method for trial monitoring has relied more heavily on the human element than on the technical. However, in the last few years, we have made much progress as an industry to make clinical trials safer and more effective.
The endeavour to encourage Risk Based Monitoring by industry and regulators, the approach to the design of adaptive trials, and the support from AI and machine learning in the monitoring of known risks as well as the alerting to unknown risks are all attempts to safeguard subjects while increasing the effectiveness of trials. We are better equipped than ever before to make trial stakeholders accountable. It is far easier for a machine to identify fraud than it is for a human being monitoring over 10,000 CRFs in the span of a week. It is simpler for an algorithm to identify discrepancies in biomarker values across visits than it is for a monitor looking through individual visits one isolated datapoint at a time.
The human’s USP is intelligence, while a machine’s is predictability. We are finally in that era of technology where we can use these two in synthesis to ensure that complex and lengthy data are accurate, subjects are safer, science is more reliably proved or otherwise. Given the level of automation we can now harness, it should no longer be acceptable for a drug to be disallowed in the market because its clinical trial was ineffectively conducted. If a drug is worthy of being made available to society, we no longer have any excuses as an industry to deprive the world of this advantage. Everyone loses. Patients. Their families. Research. Innovation. Science. Society. We cannot afford more losses. We have everything we need now to start winning more.
This is an excerpt from the Executive Director's interview with the organizers of the GCT Meet held in Barcelona in 2018.