Expert: High costs, complexity are headwinds for growing clinical trials sector

BOSTON – While the number of active clinical trials continues to increase and the drug pipeline remains healthy, several key drivers are converging to create a challenging environment for conducting these trials, said Kenneth Getz, executive director of the Tufts Center for the Study of Drug Development (CSDD). According to Getz, these include high failure rates, a poor return on investment and increasingly complex study designs.

Getz painted a mixed picture of the current environment for clinical trials to attendees at the Drug Information Association (DIA) Global Annual Meeting on 27 June. “The good news is that we are a remarkably productive enterprise as measured by the number of drugs in clinical testing … as you start to dig a little deeper you see more sobering statistics.”

The number of therapeutics in clinical testing rose 6% this year, with more than 6,000 drugs and biologics in active clinical trials. Oncology is the most active clinical area, accounting for about 25% of trials, according to Getz.

Emerging biotechs and small- to mid-size companies are fueling this growth and constitute the largest core segment of sponsors that are funding drug development activities. “This is a unique group because it relies more on intermediaries and clinical research organizations (CROs) and vendors to support activities,” Getz said.

The structure of the drug pipeline has changed, with a higher percentage of drugs and biologics being developed to treat rare diseases and personalized medicines in clinical development. While these drugs are very important, he said, they usually generate a lower rate on investment than traditional drugs.

Another trend is the increased spending on research and development, which grew from $94.2 billion in 2005 to $150.4 billion in 2020. However, this increase has not necessarily translated into more drug approvals. He said that less than 10% of drugs in development will go on to be approved and that the failure rate continues to grow.

Getz also noted that that the average duration of a clinical trial continues to swell. “In my 30 plus years in this industry I have yet to see the average time for a clinical trial getting faster. They continue to get longer,” he said.

Another obstacle is the growing complexity of clinical trials, with an increasing number of clinical endpoints being studied.

“These are hyper complex today. We continue to see high growth in endpoints. The good news is that we continue to see a steady number of primary and secondary endpoints.” The complexity comes in with the additional or tertiary endpoints to clinical studies. Having these additional endpoints often means conducting more research and going to additional countries to recruit more patients.

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Expert: High costs, complexity are headwinds for growing clinical trials sector

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