Defining “Innovativeness” in Drug Development: A Systematic Review

Abstract

Some observers of drug development argue that the pace of pharmaceutical innovation is declining, but others deny that contention. This controversy may be due to different methods of defining and assessing innovation. We conducted a systematic review of the literature to develop a taxonomy of methods for measuring innovation in drug development. The 42 studies fell into four main categories: counts of new drugs approved, assessments of therapeutic value, economic outcomes, and patents issued. The definition determined whether a study found a positive or negative trend in innovative drug development. Of 21 studies that relied on counts, 9 (43%) concluded that the trend for drug discovery was favorable, 11 (52%) concluded that the trend was not favorable, and 1 reached no conclusion. By contrast, of 21 studies that used other measures of innovation, 0 concluded that the trend was favorable, 8 (47%) concluded that the trend was not favorable, and 13 reached no conclusion (P = 0.03).

The Roles Of Academia, Rare Diseases, And Repurposing In The Development Of The Most Transformative Drugs

“…4 Drug innovation can be defined in many ways. 5 For the purposes of our study, a transformative drug was defined as one that both was innovative and had a groundbreaking effect on patient care. In two cases, a drug class as a whole was identified as being transformative in the study period, even though the first member of the class was approved by the Food and Drug Administration (FDA) before the beginning of the period (for an explanation of the methods used in selecting the study drugs, see the online Appendix).…”

Patents as a Spur to Subsequent Innovation? Evidence from Pharmaceuticals

“…Systematically quantifying differences in quality between drugs tends to be difficult; as Kesselheim, Wang, and Avorn (2013) write, prior work has looked at a variety of measures including the number of citations a drug receives in the medical literature, the number of citations its main patent receives, or simply its sales. My approach is to follow Lanthier et al (2013) and Dranove, Garthwaite, and Hermosilla (2014) in asking whether a drug received a priority review designation from the FDA.…”

Análise de medicamentos novos registrados no Brasil na perspectiva do Sistema Único de Saúde e da carga de doença

“…However, studies published in the last decade that measured the therapeutic value reported a negative trend in the innovation of new drugs. A reduced number of drugs with important innovations was detected in all studies included in the systematic review, regardless of the method used for measuring the therapeutic value 48 . This study analyzes innovation in the perspective of the therapeutic value measurement.…”

“…This controversy arises because different methods of defining pharmaceutical innovation are used 1,6,7,48 . A systematic review with the objective of identifying the methods used in determining pharmaceutical innovation trends developed a taxonomy of the strategies employed in the studies.…”

“…A systematic review with the objective of identifying the methods used in determining pharmaceutical innovation trends developed a taxonomy of the strategies employed in the studies. These strategies were classified into four categories: number of approved drugs, therapeutic value determination, economic results and published patents 48 . Studies based on the number of approved drugs have shown positive and negative innovation trends depending on the definition used, the country and the period studied.…”