Abstract
To date, there has been little agreement in the literature on what exactly constitutes radical drug innovation and how to properly measure this important construct. Without a validated measure, our ability to understand radical drug innovations, explain their origins, and demonstrate their implications for management and health policy is limited. This paper addresses the problem of radical drug innovation measurement, provides evidence of the limitations associated with the current state of the art, and offers a new method based on German health technology assessments (HTA). Data was obtained for 147 drugs authorized by the European Medicines Agency from 2011 to 2016. The innovativeness of these drugs was assessed using current measures of radical drug innovation compared with the newly developed measure. Findings indicate that current measures of radical drug innovation are associated with very inconsistent outcomes and do not appear to measure what they purport to measure. This study argues that assessing therapeutic value (as measured by the German HTA) is particularly important, given that drug novelty alone does not conclusively indicate whether a drug will deliver therapeutic value.
Similar content being viewed by others
Notes
Throughout this paper, the term radical innovation is used to describe rare and high-impact innovations, which provide competitive advantages to firms (Tushman and Anderson 1986). Other terms that are synonymous with radical innovation are breakthrough, major, and revolutionary innovations (Danneels and Kleinschmidt 2001).
A Google Scholar search on 10 February 2019 resulted in 175 papers with radical innovation in the title that had been published since the beginning of 2017.
A backward citation refers to a patent that was already available when the patent of interest was granted. A forward citation refers to newer patents that cite the patent of interest that was granted before the newer patents.
The TTO method is based on replies from a sample of people who were asked how many life years they would trade in order to avoid living with a certain health state (e.g., a specific disease or disability).
Benefit assessment of pharmaceuticals in accordance with the German Social Code, Book Five (SGB V), Sect. 35a.
Guidelines, typically developed by a specialist society, that are generally accepted in the medical community for the treatment of a disease or condition.
HTA was based on the assessment of the additional therapeutic value of drugs net of treatment risks (safety) when compared to the standard of care (i.e., the best treatment option that was available at the time of the comparison). There were no evaluations of ethical, legal, or social aspects of any drug.
References
Achilladelis, B., & Antonakis, N. (2001). The dynamics of technological innovation: The case of the pharmaceutical industry. Research Policy, 30(4), 535–588.
Ahuja, G., & Lampert, C. M. (2001). Entrepreneurship in the large corporation: A longitudinal study of how established firms create breakthrough inventions. Strategic Management Journal, 22(6–7), 521–543. https://doi.org/10.1002/smj.176
Alqahtani, S., Seoane-Vazquez, E., Rodriguez-Monguio, R., & Eguale, T. (2015). Priority review drugs approved by the FDA and the EMA: Time for international regulatory harmonization of pharmaceuticals? Pharmacoepidemiology and Drug Safety, 24(7), 709–715. https://doi.org/10.1002/pds.3793
Arnold, D. G., & Troyer, J. L. (2016). Does increased spending on pharmaceutical marketing inhibit pioneering innovation? Journal of Health Politics, Policy and Law, 41(2), 157.
Aronson, J. K., Ferner, R. E., & Hughes, D. A. (2012). Defining rewardable innovation in drug therapy. Nature Reviews Drug Discovery, 11(4), 253–254.
Arundel, A., & Kabla, I. (1998). What percentage of innovations are patented? Empirical estimates for European firms. Research Policy, 27(2), 127–141. https://doi.org/10.1016/S0048-7333(98)00033-X
Assink, M. (2006). Inhibitors of disruptive innovation capability: A conceptual model. European Journal of Innovation Management, 9(2), 215–233. https://doi.org/10.1108/14601060610663587
Bagozzi, R. P., Yi, Y., & Phillips, L. W. (1991). Assessing construct validity in organizational research. Administrative Science Quarterly, 36(3), 421–458. https://doi.org/10.2307/2393203
Bamberger, P. (2017). Construct validity research. Academy of Management Discoveries, 3(3), 235–238. https://doi.org/10.5465/amd.2017.0074
Beresniak, A., Auray, J., Duru, G., Medina-Lara, A., Tarricone, R., Sambuc, R., & Lamure, M. (2012). PRM14 European assessment of the validity of the QALY outcome measure: Results from the experiment conducted by the Echoutcome project. Value in Health, 15(7), A462.
Beresniak, A., Medina-Lara, A., Auray, J. P., De Wever, A., Praet, J. C., Tarricone, R., & Duru, G. (2015). Validation of the underlying assumptions of the quality-adjusted life-years outcome: Results from the ECHOUTCOME European project. Pharmacoeconomics, 33(1), 61–69.
Branch, S. K., & Agranat, I. (2014). “New drug” designations for new therapeutic entities: New active substance, new chemical entity, new biological entity, new molecular entity. Journal of Medicinal Chemistry, 57(21), 8729–8765. https://doi.org/10.1021/jm402001w
Brem, A., Maier, M., & Wimschneider, C. (2016). Competitive advantage through innovation: The case of Nespresso. European Journal of Innovation Management, 19(1), 133–148. https://doi.org/10.1108/EJIM-05-2014-0055
Cantner, U., Joel, K., & Schmidt, T. (2011). The effects of knowledge management on innovative success – An empirical analysis of German firms. Research Policy, 40(10), 1453–1462. https://doi.org/10.1016/j.respol.2011.06.007
Cardinal, L. B., & Hatfield, D. E. (2000). Internal knowledge generation: The research laboratory and innovative productivity in the pharmaceutical industry. Journal of Engineering and Technology Management, 17(3–4), 247–271. https://doi.org/10.1016/S0923-4748(00)00025-4
Chambers, J. D., Thorat, T., Wilkinson, C. L., & Neumann, P. J. (2017). Drugs cleared through the FDA’s Expedited Review offer greater gains than drugs approved by conventional process. Health Affairs, 36(8), 1408–1415. https://doi.org/10.1377/hlthaff.2016.1541
Chandy, R. K., & Tellis, G. J. (1998). Organizing for radical product innovation: The overlooked role of willingness to cannibalize. Journal of Marketing Research, 35(4), 474. https://doi.org/10.2307/3152166
Chang, Y.-C., Chang, H.-T., Chi, H.-R., Chen, M.-H., & Deng, L.-L. (2012). How do established firms improve radical innovation performance? The organizational capabilities view. Technovation, 32(7–8), 441–451.
Chary, K. V. (2016). Expedited drug review process: Fast, but flawed. Journal of Pharmacology and Pharmacotherapeutics, 7(2), 57.
Chiesa, V., Frattini, F., Lamberti, L., & Noci, G. (2009). Exploring management control in radical innovation projects. European Journal of Innovation Management, 12(4), 416–443. https://doi.org/10.1108/14601060910996909
Cho, S. Y., & Kim, S. K. (2017). Horizon problem and firm innovation: The influence of CEO career horizon, exploitation and exploration on breakthrough innovations. Research Policy, 46(10), 1801–1809. https://doi.org/10.1016/j.respol.2017.08.007
Ciani, O., Armeni, P., Boscolo, P. R., Cavazza, M., Jommi, C., & Tarricone, R. (2016). De innovatione: The concept of innovation for medical technologies and its implications for healthcare policy-making. Health Policy and Technology, 5(1), 47–64. https://doi.org/10.1016/j.hlpt.2015.10.005
Cohen, S. K., & Caner, T. (2016). Converting inventions into breakthrough innovations: The role of exploitation and alliance network knowledge heterogeneity. Journal of Engineering and Technology Management, 40, 29–44. https://doi.org/10.1016/j.jengtecman.2016.03.002
Cohen, W. M., & Levinthal, D. A. (1990). Absorptive capacity: A new perspective on learning and innovation. Administrative Science Quarterly, 35(1), 128–152.
Collins, F. S., & Varmus, H. (2015). A new initiative on precision medicine. The New England Journal of Medicine, 372(9), 793–795. https://doi.org/10.1056/NEJMp1500523
Colombo, M. G., von Krogh, G., Rossi-Lamastra, C., & Stephan, P. E. (2017). Organizing for radical innovation: Exploring novel insights. Journal of Product Innovation Management, 34(4), 394–405. https://doi.org/10.1111/jpim.12391
Cruz-Cázares, C., Bayona-Sáez, C., & García-Marco, T. (2013). You can’t manage right what you can’t measure well: Technological innovation efficiency. Research Policy, 42(6–7), 1239–1250. https://doi.org/10.1016/j.respol.2013.03.012
Dabisch, I., Dethling, J., Dintsios, C.-M., Drechsler, M., Kalanovic, D., Kaskel, P., et al. (2014). Patient relevant endpoints in oncology: Current issues in the context of early benefit assessment in Germany. Health Economics Review, 4(1), 2. https://doi.org/10.1186/2191-1991-4-2
Dahlin, K. B., & Behrens, D. M. (2005). When is an invention really radical? Research Policy, 34(5), 717–737. https://doi.org/10.1016/j.respol.2005.03.009
Danneels, E., & Kleinschmidt, E. (2001). Product innovativeness from the firm’s perspective: Its dimensions and their relation with project selection and performance. Journal of Product Innovation Management, 18(6), 357–373.
Darrow, J. J., Avorn, J., & Kesselheim, A. S. (2020). FDA approval and regulation of pharmaceuticals, 1983–2018. Journal of the American Medical Association, 323(2), 164–176.
Davis, C., & Abraham, J. (2011). Rethinking innovation accounting in pharmaceutical regulation: A case study in the deconstruction of therapeutic advance and therapeutic breakthrough. Science, Technology and Human Values, 36(6), 791–815. https://doi.org/10.1177/0162243910374809
de Solà-Morales, O., Cunningham, D., Flume, M., Overton, P. M., Shalet, N., & Capri, S. (2018). Defining innovation with respect to new medicines: A systematic review from a payer perspective. International Journal of Technology Assessment in Health Care, 34(3), 224–240. https://doi.org/10.1017/S0266462318000259
Dewar, R., & Dutton, J. (1986). The adoption of radical and incremental innovations: An empirical analysis. Management Science, 32(11), 1422–1433.
Dunlap, D., Marion, T., & Friar, J. (2013). The role of cross-national knowledge on organizational ambidexterity: A case of the global pharmaceutical industry. Management Learning. https://doi.org/10.1177/1350507613480099
Dunlap, D., McDonough, E. F., Mudambi, R., & Swift, T. (2016). Making up is hard to do: Knowledge acquisition strategies and the nature of new product innovation. Journal of Product Innovation Management, 33(4), 472–491. https://doi.org/10.1111/jpim.12298
Dunlap-Hinkler, D., Kotabe, M., & Mudambi, R. (2010). A story of breakthrough versus incremental innovation: Corporate entrepreneurship in the global pharmaceutical industry. Strategic Entrepreneurship Journal, 4(2), 106–127. https://doi.org/10.1002/sej.86
Eder, J., Sedrani, R., & Wiesmann, C. (2014). The discovery of first-in-class drugs: Origins and evolution. Nature Reviews Drug Discovery, 13(8), 577–587.
European Medicines Agency. (n.d.). Annual Reports and Work Programmes. https://www.ema.europa.eu/ema/index.jsp?curl=pages/about_us/document_listing/document_listing_000208.jsp&mid=WC0b01ac058002933a. Last Retrieved on May 7 2018.
European Medicines Agency. (2013). Stivarga. https://www.ema.europa.eu/en/medicines/human/EPAR/stivarga. Last Retrieved on September 7 2020.
European Medicines Agency. (2014). Mekinist. https://www.ema.europa.eu/en/medicines/human/EPAR/mekinist. Last Retrieved on September 7 2020.
European Patent Office. (n.d.). PATSTAT. https://www.epo.org/searching-for-patents/business/patstat.html. Last Retrieved on July 30 2020.
Fagerberg, J., Mowery, D. C., & Nelson, R. R. (2005). The Oxford handbook of innovation. Oxford: University Press.
Fernald, K., Pennings, H., Van Den Bosch, J., Commandeur, H., & Claassen, E. (2017). The moderating role of absorptive capacity and the differential effects of acquisitions and alliances on Big Pharma firms’ innovation performance. PLoS ONE, 12(2), e0172488.
Fricke, F.-U., & Dauben, H. P. (2009). Health technology assessment: A perspective from Germany. Value in Health, 12, S20–S27. https://doi.org/10.1111/j.1524-4733.2009.00555.x
Garcia, R., & Calantone, R. (2002). A critical look at technological innovation typology and innovativeness terminology: A literature review. Journal of Product Innovation Management, 19(2), 110–132.
Gemeinsamer Bundesausschuss. (n.d.). The benefit assessment of medicinal products in accordance with the german social code, book five (Sgb V), Section 35a. https://www.g-ba.de/english/benefitassessment. Last Retrieved on September 9 2020.
Gemeinsamer Bundesausschuss. (2016a, March). Tragende Gründe zum Beschluss des Gemeinsamen Bundesausschusses über eine Änderung der Arzneimittel-Richtlinie (AM-RL): Anlage XII - Beschlüsse über die Nutzenbewertung von Arzneimitteln mit neuen Wirkstoffen nach § 35a SGB V - Regorafenib. https://www.g-ba.de/downloads/40-268-3667/2016-03-17_AM-RL-XII_Regorafenib_2015-10-01-D-189_TrG.pdf. Last Retrieved on September 7 2020.
Gemeinsamer Bundesausschuss. (2016b). Tragende Gründe zum Beschluss des Gemeinsamen Bundesausschusses über eine Änderung der Arzneimittel-Richtlinie (AM-RL): Anlage XII - Beschlüsse über die Nutzenbewertung von Arzneimitteln mit neuen Wirkstoffen nach § 35a SGB V - Trametinib. https://www.g-ba.de/downloads/40-268-3668/2016-03-17_AM-RL-XII_Trametinib_2015-10-01-D-183_TrG.pdf. Last Retrieved on September 7 2020.
Gopalakrishnan, S., & Damanpour, F. (1997). A review of innovation research in economics, sociology and technology management. Omega, 25(1), 15–28.
Green, S. G., Gavin, M. B., & Aiman-Smith, L. (1995). Assessing a multidimensional measure of radical technological innovation. IEEE Transactions on Engineering Management, 42(3), 203–214. https://doi.org/10.1109/17.403738
Hagedoorn, J., & Cloodt, M. (2003). Measuring innovative performance: Is there an advantage in using multiple indicators? Research Policy, 32(8), 1365–1379.
Hair, J. F., Risher, J. J., Sarstedt, M., & Ringle, C. M. (2019). When to use and how to report the results of PLS-SEM. European Business Review, 31(1), 2–24.
Hair, J. F., Jr., Hult, G. T. M., Ringle, C., & Sarstedt, M. (2016). A primer on partial least squares structural equation modeling (PLS-SEM). London: Sage Publications.
Hernandez-Espallardo, M., Molina-Castillo, F., & Rodriguez-Orejuela, A. (2012). Learning processes, their impact on innovation performance and the moderating role of radicalness. European Journal of Innovation Management, 15(1), 77–98. https://doi.org/10.1108/14601061211192843
Herpers, M., & Dintsios, C.-M. (2018). Methodological problems in the method used by IQWiG within early benefit assessment of new pharmaceuticals in Germany. The European Journal of Health Economics, 2(1), 45–57.
Hohberger, J. (2016). Does it pay to stand on the shoulders of giants? An analysis of the inventions of star inventors in the biotechnology sector. Research Policy, 45(3), 682–698.
Hwang, T. J., Franklin, J. M., Chen, C. T., Lauffenburger, J. C., Gyawali, B., Kesselheim, A. S., & Darrow, J. J. (2018). Efficacy, safety, and regulatory approval of food and drug Administration-designated breakthrough and nonbreakthrough cancer medicines. Journal of Clinical Oncology, 36(18), 1805–1812.
Jayadev, A., & Stiglitz, J. (2009). Two ideas to increase innovation and reduce pharmaceutical costs and prices. Health Affairs, 28(1), 165–168. https://doi.org/10.1377/hlthaff.28.1.w165
Jiménez-Jimenez, D., Sanz Valle, R., & Hernandez-Espallardo, M. (2008). Fostering innovation: The role of market orientation and organizational learning. European Journal of Innovation Management, 11(3), 389–412. https://doi.org/10.1108/14601060810889026
Johannessen, J., Olsen, B., & Lumpkin, G. T. (2001). Innovation as newness: What is new, how new, and new to whom? European Journal of Innovation Management, 4(1), 20–31. https://doi.org/10.1108/14601060110365547
Kanter, R. (1983). The change masters. New York: Simon and Schuster.
Kaplan, S., & Vakili, K. (2015). The double-edged sword of recombination in breakthrough innovation. Strategic Management Journal, 36(10), 1437–1457.
Kennedy, I. (2009). Appraising the value of innovation and other benefits: A short study for London: NICE.
Kesselheim, A. S., Wang, B., & Avorn, J. (2013). Defining “innovativeness” in drug development: A systematic review. Clinical Pharmacology and Therapeutics, 94(3), 336–348. https://doi.org/10.1038/clpt.2013.115
Keupp, M. M., & Gassmann, O. (2013). Resource constraints as triggers of radical innovation: Longitudinal evidence from the manufacturing sector. Research Policy, 42(8), 1457–1468. https://doi.org/10.1016/j.respol.2013.04.006
Kneller, R. (2010). The importance of new companies for drug discovery: Origins of a decade of new drugs. Nature Reviews Drug Discovery, 9(11), 867–882. https://doi.org/10.1038/nrd3251
Kuhn, J., Younge, K., & Marco, A. (2020). Patent citations reexamined. The RAND Journal of Economics, 51(1), 109–132.
Lauenroth, V. D., & Stargardt, T. (2017). Pharmaceutical pricing in Germany: How is value determined within the scope of AMNOG? Value in Health, 20(7), 927–935. https://doi.org/10.1016/j.jval.2017.04.006
Lazzeri, F., Pisano, G. P. (2014). The Organizational and geographic drivers of absorptive capacity: An empirical analysis of pharmaceutical R&D laboratories. Harvard Business School Technology & Operations Mgt. Unit Working Paper No. 14–098.
Leverkus, F., & Chuang-Stein, C. (2016). Implementation of AMNOG: An industry perspective. Biometrical Journal, 58(1), 76–88. https://doi.org/10.1002/bimj.201300256
Lexchin, J. (2016). How safe and innovative are first-in-class drugs approved by health Canada: A cohort study. Healthcare Policy, 12(2), 65.
Malva, A. D., Kelchtermans, S., Leten, B., & Veugelers, R. (2015). Basic science as a prescription for breakthrough inventions in the pharmaceutical industry. Journal of Technology Transfer, 40(4), 670–695. https://doi.org/10.1007/s10961-014-9362-y
McDermott, C. M., & O’Connor, G. C. (2002). Managing radical innovation: An overview of emergent strategy issues. Journal of Product Innovation Management, 19(6), 424–438.
Midgley, D. F., & Dowling, G. R. (1978). Innovativeness: The concept and its measurement. Journal of Consumer Research, 4(4), 229–242.
Morgan, S., Lopert, R., & Greyson, D. (2008). Toward a definition of pharmaceutical innovation. Open Medicine, 2(1), e4.
Mostaghim, S. R., Gagne, J. J., & Kesselheim, A. S. (2017). Safety related label changes for new drugs after approval in the US through expedited regulatory pathways: Retrospective cohort study. British Medical Journal, 358, j3837.
Noblet, J.-P., Simon, E., & Parent, R. (2011). Absorptive capacity: A proposed operationalization. Knowledge Management Research and Practice, 9(4), 367–377. https://doi.org/10.1057/kmrp.2011.26
OECD (2015). New Sources of Growth: Phase 2, Knowledge-based Capital. Enquiries into Intellectual Property's Economic Impact. Retrieved August 23 2020 from https://www.oecd.org/sti/ieconomy/intellectual-property-economic-impact.htm.
Olson, M. K. (2008). The risk we bear: the effects of review speed and industry user fees on new drug safety. Journal of Health Economics, 27(2), 175–200.
Orianaa, C., Patrizioa, A., Robertaa, B. P., Mariannaa, C., Claudioa, J., & Rosanna, T. (2016). De innovatione: The concept of innovation for medical technologies and its implications for healthcare policy-making. Health Policy and Technology, 5(1), 47–64.
Ouellette, L. L. (2010). How many patents does it take to make a drug? Follow-on pharmaceutical patents and university licensing. Michigan Telecommunications and Technology Law Review, 17(299), 2010–2011.
Panteli, D., Eckhardt, H., Nolting, A., Busse, R., & Kulig, M. (2015). From market access to patient access: Overview of evidence-based approaches for the reimbursement and pricing of pharmaceuticals in 36 European countries. Health Research Policy and Systems. https://doi.org/10.1186/s12961-015-0028-5
Phene, A., Fladmoe-Lindquist, K., & Marsh, L. (2006). Breakthrough innovations in the US biotechnology industry: The effects of technological space and geographic origin. Strategic Management Journal, 27(4), 369–388.
Pinnow, E., Amr, S., Bentzen, S. M., Brajovic, S., Hungerford, L., & George DalPan, D. M. G. (2018). Postmarket safety outcomes for new molecular entity (NME) drugs approved by the Food and Drug Administration between 2002 and 2014. Clinical Pharmacology and Therapeutics, 104(2), 390–400.
Postma, M. J., Boersma, C., Vandijck, D., Vegter, S., Le, H. H., & Annemans, L. (2011). Health technology assessments in personalized medicine: Illustrations for cost–effectiveness analysis. Expert Review of Pharmacoeconomics and Outcomes Research, 11(4), 367–369. https://doi.org/10.1586/erp.11.50
Salavou, H. (2004). The concept of innovativeness: Should we need to focus? European Journal of Innovation Management, 7(1), 33–44. https://doi.org/10.1108/14601060410515628
Scheithauer, W. (2012). Faculty opinions recommendation of Grothey A et al. Lancet. Faculty Opinions. https://doi.org/10.3410/f.717965145.793466450
Schlette, S., & Hess, R. (2013). Issues in international health policy. Issue brief (Commonwealth Fund), 29, 1–9.
Schmid, E. F., & Smith, D. A. (2005). Managing innovation in the pharmaceutical industry. Journal of Commercial Biotechnology, 12(1), 50–57.
Shane, S. (2001). Technological opportunities and new firm creation. Management Science, 47(2), 205–220.
Singh, J., & Fleming, L. (2010). Lone inventors as sources of breakthroughs: Myth or reality? Management Science, 56(1), 41–56. https://doi.org/10.1287/mnsc.1090.1072
Skipka, G., Wieseler, B., Kaiser, T., Thomas, S., Bender, R., Windeler, J., et al. (2016). Methodological approach to determine minor, considerable, and major treatment effects in the early benefit assessment of new drugs: Determine minor, considerable and major treatment effects. Biometrical Journal, 58(1), 43–58. https://doi.org/10.1002/bimj.201300274
Smith, K. J., & Roberts, M. S. (2000). The cost–effectiveness of sildenafil. Annals of Internal Medicine, 132, 933–937.
Sorescu, A. B., Chandy, R. K., & Prabhu, J. C. (2003). Sources and financial consequences of radical innovation: Insights from pharmaceuticals. Journal of Marketing, 67(4), 82–102.
Stafford, R. S., Wagner, T. H., & Lavori, P. W. (2009). New, but not improved? Incorporating comparative-effectiveness information into FDA labeling. New England Journal of Medicine, 361(13), 1230–1233. https://doi.org/10.1056/NEJMp0906490
Sternitzke, C. (2010). Knowledge sources, patent protection, and commercialization of pharmaceutical innovations. Research Policy, 39(6), 810–821.
Suzuki, O., & Methe, D. T. (2014). Local search, exploration frequency, and exploration valuableness: Evidence from new pharmaceuticals development. International Journal of Innovation Management, 18(02), 1450014. https://doi.org/10.1142/S1363919614500145
thinkBiotech LLC. (n.d.). Drug patent watch. https://www.drugpatentwatch.com. Last Retrieved on July 7 2020.
Tijssen, R. J. W. (2001). Global and domestic utilization of industrial relevant science: Patent citation analysis of science-technology interactions and knowledge flows. Research Policy, 30(1), 35–54. https://doi.org/10.1016/S0048-7333(99)00080-3
Trajtenberg, M. (1990). A penny for your quotes: Patent citations and the value of innovations. The Rand Journal of Economics, 21, 172–187.
Trajtenberg, M., Henderson, R., & Jaffe, A. (1997). University versus corporate patents: A window on the basicness of invention. Economics of Innovation and New Technology, 5(1), 19–50.
Tushman, M. L., & Anderson, P. (1986). Technological discontinuities and organizational environments. Administrative Science Quarterly, 31(3), 439. https://doi.org/10.2307/2392832
US Food & Drug Administration. (n.d.-a). Orange Book: Approved drug products with therapeutic equivalence evaluations. https://www.accessdata.fda.gov/scripts/cder/ob/index.cfm. Last Retrieved on August 20 2020.
US Food & Drug Administration. (n.d.-b). Purple book database of licensed biological products. https://purplebooksearch.fda.gov. Last Retrieved on August 20 2020.
US Food & Drug Administration. (n.d.-c). Drugs@FDA: FDA-Approved Drugs. https://www.fda.gov/drugsatfda. Last Retrieved on May 7 2018.
US Food & Drug Administration. (2012, September 20). Center for Drug Evaluation and Research Application Number 203085Orig1s000 Summary Review. https://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/203085Orig1s000SumR.pdf. Last Retrieved on September 7 2020.
US Food & Drug Administration. (2013, May 28). Center for Drug Evaluation and Research Application Number 204114Orig1s000 Summary Review. https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/204114Orig1s000SumR.pdf. Last Retrieved on September 7 2020.
US Food & Drug Administration. (2018, February 23). Fast Track, Breakthrough Therapy, Accelerated Approval, Priority Review. https://www.fda.gov/patients/learn-about-drug-and-device-approvals/fast-track-breakthrough-therapy-accelerated-approval-priority-review. Last Retrieved on September 5 2020.
US Food & Drug Administration. (2020). Advancing health through innovation: New drug therapy approvals 2019. https://www.fda.gov/drugs/new-drugs-fda-cders-new-molecular-entities-and-new-therapeutic-biological-products/new-drug-therapy-approvals-2019. Last Retrieved on August 20 2020.
US National Library of Medicine. (2015, June 24). Patients with metastatic colorectal cancer treated with regorafenib or placebo after failure of standard therapy. https://clinicaltrials.gov/ct2/show/NCT01103323. Last Retrieved on September 7 2020.
US National Library of Medicine. (2018, April 5). GSK1120212 vs Chemotherapy in advanced or metastatic BRAF V600E/K Mutation-positive Melanoma. https://clinicaltrials.gov/ct2/show/NCT01245062. Last Retrieved on September 7 2020.
Verhoeven, D., Bakker, J., & Veugelers, R. (2016). Measuring technological novelty with patent-based indicators. Research Policy, 45(3), 707–723. https://doi.org/10.1016/j.respol.2015.11.010
Wallach, J. D., Ross, J. S., & Naci, H. (2018). The US Food and Drug Administration’s expedited approval programs: Evidentiary standards, regulatory trade-offs, and potential improvements. Clinical Trials, 15(3), 219–229.
Wang, C. L., & Ahmed, P. K. (2004). The development and validation of the organisational innovativeness construct using confirmatory factor analysis. European Journal of Innovation Management, 7(4), 303–313.
Weinstein, M. C., Russell, L. B., Gold, M. R., & Siegel, J. E. (1996). Cost-effectiveness in health and medicine. New York: Oxford University Press.
Wieseler, B., McGauran, N., & Kaiser, T. (2019). New drugs: Where did we go wrong and what can we do better? British Medical Journal, 366, l4340.
Yamin, M., & Otto, J. (2004). Patterns of knowledge flows and MNE innovative performance. Journal of International Management, 10(2), 239–258. https://doi.org/10.1016/j.intman.2004.02.001
Zucker, L. G., Darby, M. R., & Armstrong, J. S. (2002). Commercializing knowledge: University science, knowledge capture, and firm performance in biotechnology. Management Science, 48(1), 138–153. https://doi.org/10.1287/mnsc.48.1.138.14274
Author information
Authors and Affiliations
Corresponding author
Additional information
The paper represents the author’s personal opinion and does not necessarily reflect the views of F. Hoffmann – La Roche AG or its staff.
Rights and permissions
About this article
Cite this article
Stiller, I., van Witteloostuijn, A. & Cambré, B. Do current radical innovation measures actually measure radical drug innovation?. Scientometrics 126, 1049–1078 (2021). https://doi.org/10.1007/s11192-020-03778-x
Received:
Published:
Issue Date:
DOI: https://doi.org/10.1007/s11192-020-03778-x