The Past and Future of Clinical Trials – Part I

Today is a very important day on our calendar – it’s International Clinical Trials Day, May the 20th. Dr. James Lind is recognized as the first physician to have conducted a controlled clinical trial in the modern era. Lind was a Scottish naval surgeon and worked on British Royal Navy ships in the 16th century. He noticed the high mortality of scurvy among the sailors and planned a comparative trial of the most promising cure for this ailment. The date he conducted this trial was May 20th, 1747.

Clinical trials have come a long way since Lind’s search for a cure for scurvy. But we still have a long way to go. Let’s start with a sobering statistic: Of all the drugs started in clinical trials on humans, only 10 percent secure approval. Not only that, roughly only 1 in every 5,000 compounds that drug companies discover and put through preclinical testing ultimately becomes an approved drug. These statistics are about drugs, but that is not the only scope for clinical trials. Clinical trials are designed to answer specific questions about new treatments, such as novel vaccines, drugs, but they also focus on new dietary choices, dietary supplements, and medical devices. So the impact of failed clinical trials is enormous—not only because it comes at a huge financial loss, but even more because it implies a direct loss of human lives—by not allowing lifesaving drugs, procedures, and medical devices to be available in time. 

Why are clinical trials so prone to failure? There are many reasons. 

A significant number of clinical trials fail every year because of inadequate financial support, poor protocol designs, an inability to recruit the right patients, and a lack of good software tools to conduct the trial, among other reasons. By consequence, lifesaving drugs, innovative devices, and great research fail to reach the patients who need help desperately.

Retention is a critical issue: 85% of clinical trials fail to retain enough patients. Timeliness is problematic: 80% of clinical trials do not end on time. Under-enrollment is common: 50% of sites cannot enroll enough patients to be viable. Furthermore, 30% of patients drop out of trials, and that’s just on average. In certain cases, the percentage is much higher. The entire arena of clinical trial preparation, execution, and reporting faces many problems, and we need to do better.

We leave today with another sobering statistic. Last year, over 1.7 million people in the United States were diagnosed with cancer for the first time. Around 10,000 clinical trials were run to test potentially life-saving cancer drugs, which ended up enrolling less than 5% of these patients. We must do better than this, but how? The $65B clinical trials market is screaming for a makeover. The question to ponder is: Can the adoption of latest technological advancements in artificial intelligence help alleviate these issues and help design, conduct, and report more effective clinical trials? That will be the topic of this blog in the next few weeks and months. Stay tuned!