Clinical trials are slow and expensive. Any delays cause increases in price and decreases the speed at which new therapies make it to patients. One way to speed up trials is to avoid delays, and one way to avoid delays is to leverage insights into the clinical trial’s performance, as it goes. To be clear, we aren’t talking about breaking blinding to see how successfully a drug is performing – rather, these are insights ranging from challenges recruiting patients for trials to protocol issues to safety monitoring. Strategically tapping into these insights enables faster protocol amendments, proactive mitigation of safety issues, and rapid identification of recruitment challenges. All of which can speed up trials’ progress. Let’s look at each in turn.
Quicker Protocol Amendments
Understanding the efficiency and feasibility of trial protocols is a baseline success determinant for any clinical trial. In this context, monitoring and deriving insights from key performance indicators related to protocol adherence, deviations and violations can be game-changing.
A protocol amendment might be needed if there seems to be an increase in deviations or subject drop-offs, indicating an unrealistic or complex protocol design. The ability to see these coming and head them off sooner can mitigate costly delays associated with the amendments (or worse, running a bad trial for a long time).
Proactive Mitigation of Safety Issues
The patient’s safety is the highest priority in clinical trials, and any compromise can derail a study’s progress. Real-time performance metrics involving adverse event occurrence, serious adverse event reports, medication errors, etc., can be critical in understanding the safety schema of the trial. These data points can be readily analyzed to gauge early signs of safety risks that might have otherwise gone unnoticed.
Moreover, these insights can guide a proactive approach, allowing timely intervention or overhaul of a particular trial segment to ensure patient safety. Thus, avoiding major halts or interruptions related to safety issues can significantly reduce trial timelines, improving cost efficiency while safeguarding patient health.
Identification of Recruiting Problems
Participant recruitment continues to be a major bottleneck in clinical trial progress, and challenges associated with it often lead to project delays. Again, this is an opportunity for insights to provide a clear view into potential issues.
Are existing recruitment strategies effective? Are potential participants dropping off during the informed consent process? How well is the trial site performing the recruitment tasks? Answers to these questions lie in thoroughly scrutinized performance data. Based on these data-driven insights, trial teams can alter strategies to overcome recruitment hurdles more quickly, aiding in reducing trial durations.
The Role of Technology
The key to any of these insights are robust data analytics that provide easy-to-understand and actionable insights. Luckily, AI technologies have come a long way in supporting both the analytics and the output generation. At ReadoutAI, we leverage AI to both do the correct biostatistics and then describe the results in paragraphs. Users get the benefit of comprehendible summaries backed by data. These automatically generated reports can both be used during a trial for insights and at the end for reporting.
It’s clear that technology can lead to more analytics of clinical trial performance which can significantly expedite drug development and approval. And most importantly, it’s ultimately the patients that will benefit.