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Are development times for pharmaceuticals increasing or decreasing?

Salomeh Keyhani¹, Marie Diener-West, Neil Powe

¹Mount Sinai School of Medicine, New York City, USA. Salomeh.Keyhani@mountsinai.org

Health Affairs (Project Hope)

|March 9, 2006

Summary

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Drug development timelines, including clinical trial durations, have not increased. This suggests longer clinical trial times are not driving rising prescription drug prices.

Area of Science:

Pharmacoeconomics
Drug Development
Regulatory Science

Background:

Rising prescription drug prices are a significant concern for patients and healthcare systems.
Longer drug development times, particularly clinical trial durations, are often cited as a contributing factor to increased drug costs.
Existing analyses of drug development times frequently rely on proprietary datasets, limiting transparency and independent verification.

Purpose of the Study:

To investigate trends in drug development timelines using publicly available data.
To determine if clinical trial periods have lengthened over time.
To assess the relationship between drug development times and rising prescription drug prices.

Main Methods:

Analysis of publicly accessible data for 168 drugs approved between 1992 and 2002.

Related Experiment Videos

Examination of trends in both clinical trial durations and regulatory review periods.

Statistical assessment of changes in development times over the specified period.

Main Results:

The median clinical trial period was 5.1 years, and the median regulatory review period was 1.2 years for drugs approved between 1992 and 2002.
No significant increase in clinical trial durations was observed during this decade.
A decrease in regulatory review periods was noted over the study timeframe.

Conclusions:

Contrary to common assumptions, clinical trial times have remained stable.
Decreasing regulatory review periods further challenge the notion that extended development phases inflate drug prices.
It is unlikely that extended clinical trial durations are a primary driver of increasing prescription drug costs.