Large molecule clinical trials taking longer, costing more

By Melissa Fassbender

- Last updated on GMT

(Image: iStock/Max2611)
(Image: iStock/Max2611)

Related tags Clinical trial

Significant differences in large molecule clinical trials highlights the need to be more efficient, according to a recent analysis of clinical trial duration.

The analysis, conducted by KMR Group​, evaluated cycle time performance for more than 17,000 interventional trials from trials conducted between 2005 to 2015.

We have been analyzing the clinical trial differences by molecule type for several years, and seeing the differences in both length of time and costs truly magnifies the need to be operationally efficient​,” Linda Martin, KMR Group President and Founder, told

The report analyzed a variety of factors, including outsourcing, disease complexity, study size, and subject type, and found that large molecule trials are regularly longer “at a statistically significant level​.”

According to the report, this is true across trial phases. For Phase III oncology trials specifically, KMR Group found the total duration for small molecules is a median 4.5 years compared to 6.1 years for large molecules.

In Oncology, not only are large molecule trials taking longer, but the costs per month are higher as well​,” explained Martin.

Several factors contribute to the longer trial time, including study startup, enrollment, and data capture.

According to the report, large molecule trials recruit at a lower rate, with small molecule studies recruiting a median 17.5 subjects per month in Phase III for oncology, compared to 14.2 subjects per month for large.

There may be some outstanding new biologic therapies on the horizon, but for the companies developing these drugs, identifying areas for operational improvement has never been more critical​,” said Martin.

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