Are Clinical Trial Wait Times Delaying Drug Discovery?

Just ten years ago, it took an average of six months to get a clinical trial for a new drug off the ground. Choosing the right clinical setting, recruiting the test patients, and then getting the trial started was all accomplished in that time period. But these days, it’s taking an average of 31 weeks – nearly eight months – to do the same, according to the Tufts Center for the Study of Drug Development.

Why are clinical trial wait times so much longer in this more advanced modern decade? And is this delay causing a delay in the discovery of life-saving medicines? The answers aren’t as clear as one might hope.
 

Why Clinical Trial Wait Times Are Growing

There are a few reasons why it takes longer today to get a clinical trial started. Some of those include:

• Negotiations with hospitals or clinics are taking longer.
• The focus on solutions for rare diseases makes it harder to find test patients.
• The new interest in approving the ethical standards of a trial before it begins can make the process take longer.
• Complex testing to ensure that a gene-based medicine will be effective on a patient makes the trial take longer.

What This Means for New Drug Discovery

Regardless of how long the clinical trial wait time is, it has historically always taken years for a new drug to be created, tested, approved, and then sold. However, could the significant increase in clinical trials be making it harder for companies to create and sell new treatments for diseases?

Overall, the evidence points more to the higher cost of failed clinical trials — rather than the wait time — as the leading factor in why fewer drugs are being made for the market. Just four years ago, only 32% of drugs were making it through Phase 3 trials, and the number of successful trials since then has continued to decline. The chance of a drug being approved by the FDA today is about 10%.

Failed clinical trials cost up to $1.4 billion, and rarely cost less than several hundred million dollars. This can put a big burden on companies, who then cannot put money into developing new drugs. Add in the longer clinical trial wait times, and the chance of a new drug being released to the market is extremely slim.

Looking Ahead

Drug companies today are attempting to solve this critical problem through a variety of means, such as:

• Learning to better utilize the vast amounts of data the industry has collected
• Focusing on drugs for rarer or neglected diseases, which have a shorter regulatory process
• Collaborating with other drug companies in the industry
• Prioritizing selecting patients based on biomarkers that would indicate a higher rate of success with the drug



All of these methods can make it more affordable and faster to test a drug, and more likely that it will be approved by the FDA. Until these things are adopted by the industry as a whole, however, clinical trial wait times will continue to be one factor in the delay of new medical discovery.