Failed Oncology Trials May Cost Up to $60 Billion Per Year

Researchers have estimated that failed oncology trials cost about $50 billion to $60 billion each year.¹

As an example of failed development, the researchers evaluated trials designed to test IGF-1R inhibitors for oncology indications. Their findings were published in JAMA Network Open.

The researchers evaluated data for 16 IGF-1R inhibitors that were tested in 183 oncology trials conducted between 2003 and 2021. The trials encompassed a total of 12,396 patients with a range of hematologic cancers and solid tumors.

Though the IGF-1R inhibitors had shown activity in preclinical studies, none demonstrated adequate efficacy to support regulatory approval for oncology indications.

The trials were estimated to cost between $1.6 billion and $2.3 billion. The researchers also calculated the cost of all failed oncology trials and estimated an annual cost of $50 billion to $60 billion.

The author of a related editorial proposed several measures for reducing trial failures and related costs.² Demanding better preclinical data and ensuring that trials include good biomarkers are 2 important measures, according to the editorialist, Tito Fojo, MD, PhD, of Columbia University Medical Center in New York, New York.

Dr Fojo also argued that institutional review boards should pay close attention to the “repeated failures of a therapeutic class” to avoid approving studies that are likely to fail.

“Equally important, we must address the issue of pharmaceutical companies that embark on these journeys to failure, while ignoring countless warning signs, and then ascribe their expenditures to the cost of doing business,” Dr Fojo wrote.

He argued that this is particularly important because the costs of these failures are recouped via increasing drug costs. Society can accept paying for successful drug development but should not accept “failures that were clearly due to poor decisions and bad judgment,” Dr Fojo wrote.

Disclosures: Dr Fojo reported no disclosures. One study author declared affiliations with biotech, pharmaceutical, and/or device companies. Please see the original reference for a full list of disclosures.

References

1. Jentzsch V, Osipenko L, Scannell JW, Hickman JA. Costs and causes of oncology drug attrition with the example of insulin-like growth factor-1 receptor inhibitors. JAMA Netw Open. Published online July 28, 2023. doi:10.1001/jamanetworkopen.2023.24977

2. Fojo T. Journeys to failure that litter the path to developing new cancer therapeutics. JAMA Netw Open. Published online July 28, 2023. doi:10.1001/jamanetworkopen.2023.24949

This article originally appeared on Cancer Therapy Advisor