Overcoming the "valley of death" in medical research and development: relevance and key issues

This article examines the challenge of bridging the "valley of death" in medical research and development (R&D) — a critical phase where many promising projects fail to advance to implementation and commercialization. This study analyzes organizational, legal, financial, economic, and methodological obstacles that hinder the translation of scientific discoveries into practical healthcare. This study focuses on the Russian legislative framework governing scientific research and analyzes the socioeconomic impact of adopting new medical technologies based on international experience. The article highlights a paradox: despite substantial investments in medical R&D, many projects fail due to difficulties in assessing their innovative potential, inadequate coordination among stakeholders, and stringent regulatory requirements. The authors propose potential solutions, such as fostering public-private partnerships, streamlining regulatory processes, advancing translational medicine, and implementing knowledge management systems. This article is intended for researchers, regulators, pharmaceutical industry representatives, and healthcare policymakers seeking to accelerate the adoption of medical innovations.

1. Zudin AB, Gurtskoy LD, Ananchenkova PI. Knowledge management as a management function. City Healthcare. 2023;4(1):98-104. (In Russ.).

2. Aggestam L, Durst S, Persson A. Critical Success Factors in Capturing Knowledge for Retention in IT-Supported Repositories. Information. 2014; 5(4):558-569. Doi: 10.3390/info5040558.

3. Wu I-L, Chen J-L. Knowledge Management Driven Firm Performance: The Roles of Business Process Capabilities and Organisational Learning. Journal of Knowledge Management. 2014;18: 1141-1164. Doi: 10.1108/JKM-05-2014-0192.

4. Lyu H, Zhou Z, Zhang Z. Measuring Knowledge Management Performance in Organizations: An Integrative Framework of Balanced Scorecard and Fuzzy Evaluation. Information. 2016;7(2):29. DOI: 10.3390/info7020029.

5. Bui V, Stolpe M. The impact of new drug launches on the loss of labor from disease and injury: evidence from German panel data. Int J Health Care Finance Econ. 2010;10:315-346. DOI: 10.1007/s10754-010-9083-1.

6. Zozaya N, Alcalá B, Galindo J. The offset effect of pharmaceutical innovation: A review study. Global & Regional Health Technology Assessment. 2019;2019. doi: 10.1177/2284240319875108.

7. Shatkovskaya TV. Scientific Results of Intellectual Activity as Objects of Exclusive Rights: Concept and Features of Legal Protection. North Caucasian Law Bulletin. 2019;(2):9–14.

8. Morozova Yu. A., Boshkovich R. Strategic planning in medical organizations. Features of corporate strategy formation. Strategizing: Theory and Practice. 2024;4(11):133-148..

9. Egorov M.A., Bazhenova S.A., Rastegaeva N.A., et al. Review of investments in the development of the Russian Medtech market and the prospects for the impact of digitalization in medicine on the economic performance of companies until 2030. Problems of Social Hygiene, Healthcare and the History of Medicine. 2024;32(S1):588-593..

10. Khrustalev M.B., Maksimova A.A. Effective search for potentially innovative scientific results in medicine. FARMAKOEKONOMIKA. Modern Pharmacoeconomics and Pharmacoepidemiology. 2019;12(1):27-33. (In Russ.).

11. Habib AR, Lin AL, Grant RW. The Epic Sepsis Model Falls Short-The Importance of External Validation. JAMA Intern Med. 2021 Aug 1;181(8): 1040-1041. doi: 10.1001/jamainternmed.2021.3333.

12. Edelson DP, Churpek MM, Carey KA, Lin Z, Huang C, Siner JM, Johnson J, Krumholz HM, Rhodes DJ. Early Warning Scores With and Without Artificial Intelligence. JAMA Netw Open. 2024 Oct 1;7(10):e2438986. doi: 10.1001/jamanetworkopen.2024.38986. Erratum in: JAMA Netw Open. 2024 Nov 4;7(11):e2448969. doi: 10.1001/jamanetworkopen.2024.48969.

13. Byrd TF 4th, Southwell B, Ravishankar A, Tran T, Kc A, Phelan T, Melton-Meaux GB, Usher MG, Scheppmann D, Switzer S, Simon G, Tignanelli CJ. Validation of a Proprietary Deterioration Index Model and Performance in Hospitalized Adults. JAMA Netw Open. 2023 Jul 3;6(7):e2324176. doi: 10.1001/jamanetworkopen.2023.24176.

14. van Buchem MM, Boosman H, Bauer MP, Kant IMJ, Cammel SA, Steyerberg EW. The digital scribe in clinical practice: a scoping review and research agenda. NPJ Digit Med. 2021 Mar 26;4(1):57. doi: 10.1038/s41746-021-00432-5.

15. Mitchell WG, Wawira JG, Celi LA. Rebooting artificial intelligence for health. PLOS Glob Public Health. 2025 Jan 17;5(1):e0004171. doi: 10.1371/journal.pgph.0004171.

16. Venkatakrishnan K, Ecsedy JA. Enhancing value of clinical pharmacodynamics in oncology drug development: An alliance between quantitative pharmacology and translational science. Clin Pharmacol Ther. 2017 Jan;101(1):99-113. doi: 10.1002/cpt.544.

17. David E, Tramontin T, Zemmel R. Pharmaceutical R&D: the road to positive returns. Nat Rev Drug Discov. 2009 Aug;8(8):609-10. doi: 10.1038/nrd2948.

18. Seruga B, Ocana A, Amir E, Tannock IF. Failures in Phase III: Causes and Consequences. Clin Cancer Res. 2015 Oct 15;21(20):4552-60. doi: 10.1158/1078-0432.CCR-15-0124.

19. Volodin N.N. New approaches to solving old problems: history lessons. PULMONOLOGIYA. 2024;34(3):334-339. (In Russ.).

20. Smith DP, Perez JA. Noninvasive inhaled nitric oxide for persistent pulmonary hypertension of the newborn: A single center experience. J Neonatal Perinatal Med. 2016 May 19;9(2):211-5. doi: 10.3233/NPM-16915092.

21. Donate MJ, Sánchez de Pablo JD. The role of knowledge-oriented leadership in knowledge management practices and innovation. Journal of business research. 2015;68(2):360-370. DOI: 10.1016/j.jbusres.2014.06.022.