iSelect Fund

Craig Herron

Clinical trials are an extremely important part of the drug development process and are crucial in developing both safe and effective drugs. At their best, they can help understand the significance of a potential new drug and help advance the field of medicine, without compromising patient safety.

However, they are not without their challenges.

Clinical trials are research studies in which one or more human subjects are assigned to one or more medical interventions to evaluate the effects of those interventions on health-related biomedical or behavioral outcomes. Unfortunately, these trials are notorious for their cost, length, and high failure rate. Traditional clinical trials can cost millions of dollars, take many years to complete, and face increasingly stringent demands from regulators. While they are a necessary part of the drug and treatment development process, they do introduce pain points to the industry that can slow down the time to market.

Part of the problem is rooted in finding patients to participate.

In fact, 86 percent of clinical trials fail to reach recruitment goals within their targeted timeframe, and there has been a 29 percent drop in trial enrollments since 2014. Simply finding eligible patients for a trial is becoming increasingly difficult. Recruitment and retention alone represent a $3.2B cost center for the biopharmaceutical industry that is expected to reach $5.3B by 2030.

As many as half of the patients in any trial don’t even receive the drug or therapy that is being tested, as they are the control arm against which the success of failure of the test is based. But they still need to be recruited and managed as part of the trial, costing organizers both time and money.

These kinds of associated costs have also been blamed for driving up the costs of drugs to end consumers. The median estimated cost of a clinical trial was $19 million as of 2018, and the industry spends $80 billion as a whole on clinical trials each year despite very low success rates. It’s been estimated that each month that the drug development process is shortened is worth $25 million for the average sponsor.

And the challenges associated with trials are getting harder to overcome.

New types of biopharmaceuticals and therapies, such as protein biologics, cell therapies, and gene therapies, also present unique challenges and requirements, not to mention the fact that there are now more trials than ever before, more than 290,000 globally in the last year.

That said, a number of companies are working to reduce the pain points around clinical trials while improving their efficacy. From improving clinical trial recruitment to increasing patient engagement to automating aspects of clinical trial administration and data collection, numerous startups are helping lead the way driving new technologies that can reduce the cost, time and improve the quality of clinical trials and drug development.

That’s where we’re seeing opportunities in this market.

• Technologies to improve recruitment are gathering and analyzing more data to find better matches for trials as well as more potential patients.

• Software and connected devices are being used to improve trial retention, reducing the staffing and monitoring burden at clinical trial sites while simultaneously improving data quality and adherence.

• Control populations cost trial organizers both time and money, but creating synthetic populations to represent the control part of the equation can potentially cut the number of patients needed for trials in half.

Will these steps solve the challenges facing drug developers? It depends. Regulators will need to be convinced of the safety and efficacy of any new methods to recruit or run clinical trials, and gaining that support will likely take time. Plus, many of the companies working in this space are early-stage, and we don’t yet know what to expect from their work.

Whatever the case, it will take some time before any major changes come to the clinical trial system as we know it today.

But that doesn’t mean this isn’t an effort worth undertaking. As the global population continues to grow and live longer, we’re going to need access to new and better medical treatments to address chronic disease and other age-related conditions. The legacy system of clinical trials was not designed to support drug development at this kind of scale. It won’t happen overnight, but technologies like those mentioned above will help support new approaches to clinical trials that will drive the medical field forward for years to come.

 Craig Herron is Managing Director of iSelect Fund in St. Louis, MO.

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