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Defining "innovativeness" in drug development: a systematic review.
A S Kesselheim1, B Wang, J Avorn
1Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women's Hospital and Harvard Medical School, Boston, Massachusetts, USA. akesselheim@partners.org
Clinical Pharmacology and Therapeutics
|June 1, 2013
Summary
The definition of pharmaceutical innovation significantly impacts study conclusions. Counting new drugs approved shows mixed trends, while other measures like therapeutic value indicate a decline in drug development innovation.
Area of Science:
- Pharmaceutical Science
- Health Economics
- Biotechnology
Background:
- Debate exists regarding the pace of pharmaceutical innovation.
- Discrepancies in findings may stem from varied innovation assessment methods.
Purpose of the Study:
- To systematically review and categorize methods for measuring innovation in drug development.
- To analyze how different measurement approaches influence conclusions about innovation trends.
Main Methods:
- Conducted a systematic literature review of 42 studies on drug development innovation.
- Classified studies into four main categories: drug counts, therapeutic value, economic outcomes, and patents.
- Analyzed the conclusions of studies based on their chosen innovation metrics.
Main Results:
- Studies using drug counts reported mixed trends (43% favorable, 52% unfavorable).
- Studies using alternative measures (therapeutic value, economic outcomes, patents) showed no favorable trends (0% favorable, 47% unfavorable, 47% inconclusive).
- A statistically significant difference (P = 0.03) was observed between the two measurement approaches.
Conclusions:
- The method used to define and measure pharmaceutical innovation critically influences the perceived trend.
- Reliance on simple drug counts may overestimate innovation compared to assessments of therapeutic value or economic impact.
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