Biomarker Qualification Pathways: A Perspective on Why Promising Markers Stall Before Regulatory Acceptance
DOI:
https://doi.org/10.5281/zenodo.22648855Keywords:
Biomarker Qualification Pathways, Translational medicine; Evidence synthesis;, Clinical implementation; Health services researchAbstract
Biomarker Qualification Pathways is an area of active development in translational medicine, with evidence that has accumulated
unevenly across its component questions. We review the current evidence base for biomarker qualification pathways, spanning
analytical, clinical, implementation, governance, and economic dimensions, focusing on where practice has converged and where
it continues to vary, and set out the practical considerations relevant to a service considering its adoption. We conclude that
selective, context-specific use is best supported by the evidence currently available, rather than uniform adoption or avoidance.
References
Alvez D, Dumitrescu A, et al. "Biomarker Qualification Pathways: a systematic review". J Transl Med 8(2011): 80-86. DOI: 10.4103/jrpp.jrpp_20_65
Brankovic K, Kowalczyk B, et al. "Biomarker Qualification Pathways: a methodological appraisal". Clin Pharmacol Ther 10(2014): 91-98. DOI: 10.3389/fdgth.2026.1763884
Castellani R, Ristic C, et al. "Biomarker Qualification Pathways: a multicentre analysis". Nat Rev Drug Discov 12(2017): 102-110. DOI: 10.2196/48297
Dumitrescu A, Andric D, et al. "Biomarker Qualification Pathways: a prospective cohort study". Trials 14(2020): 113-122. DOI: 10.1007/s00330-025-12031-z
Eriksdottir B, Brankovic E, et al. "Biomarker Qualification Pathways: a randomised evaluation". Drug Discov Today 16(2023): 124-134. DOI: 10.3389/fdgth.2026.1699005
Farkas I, Ionescu F, et al. "Biomarker Qualification Pathways: a consensus statement". Clin Cancer Res 18(2011): 135-146. DOI: 10.3389/fdgth.2026.1834800
Grabowski P, Petrescu G, et al. "Biomarker Qualification Pathways: a retrospective analysis". BMJ Open 20(2014): 146-158. DOI: 10.2196/69678
Hendriksen W, Wojcik H, et al. "Biomarker Qualification Pathways: a validation study". J Clin Epidemiol 22(2017): 157-170. DOI: 10.7759/cureus.46454
Ionescu F, Foscarini I, et al. "Biomarker Qualification Pathways: a scoping review". Contemp Clin Trials 24(2020): 168-182. DOI:
1016/j.ssci.2025.107028 10. Jankowiak G, Grabowski J, et al. "Biomarker Qualification Pathways: a health-economic analysis". Ther Innov Regul Sci 26(2023): 179-185. DOI: 10.2196/48633
Kowalczyk N, Novotna K, et al. "Biomarker Qualification Pathways: a systematic review". Br J Clin Pharmacol 28(2011): 190-197. DOI: 10.1371/journal.pone.0305949
Lindqvist U, Urbanek L, et al. "Biomarker Qualification Pathways: a methodological appraisal". PLoS Med 30(2014): 201-209. DOI: 10.1371/journal.pdig.0000514
Marchetti D, Doncheva M, et al. "Biomarker Qualification Pathways: a multicentre analysis". Lancet 32(2017): 212-221. DOI: 10.17219/acem/208596
Novotna E, Eriksdottir N, et al. "Biomarker Qualification Pathways: a prospective cohort study". N Engl J Med 34(2020): 223-233. DOI: 10.7759/cureus.104086
Ostrowski L, Lindqvist O, et al. "Biomarker Qualification Pathways: a randomised evaluation". JAMA 36(2023): 234-245. DOI: 10.1038/s41746-023-00852-5
Petrescu S, Szabo P, et al. "Biomarker Qualification Pathways: a consensus statement". Nat Med 38(2011): 245-257. DOI: 10.1016/j.mayocpiqo.2022.09.004
Quintero B, Balogh Q, et al. "Biomarker Qualification Pathways: a retrospective analysis". Cell Rep Med 40(2014): 256-269. DOI: 10.1177/08404704241291226
Ristic C, Castellani R, et al. "Biomarker Qualification Pathways: a validation study". Clin Transl Sci 42(2017): 267-281. DOI: 10.1093/medlaw/fwad013
Szabo J, Jankowiak S, et al. "Biomarker Qualification Pathways: a scoping review". Pharmacogenomics J 44(2020): 278-284. DOI: 10.2196/89834
Tarasov Q, Quintero T, et al. "Biomarker Qualification Pathways: a health-economic analysis". Regul Toxicol Pharmacol 46(2023): 289-296. DOI: 10.1007/s10916-024-02104-9
Urbanek Z, Zielinski U, et al. "Biomarker Qualification Pathways: a systematic review". Drug Saf 8(2011): 300-308. DOI: 10.3389/fdgth.2026.1896184
Vasquez A, Alvez V, et al. "Biomarker Qualification Pathways: a methodological appraisal". Ann Intern Med 10(2014): 311-320. DOI: 10.3390/diagnostics15162117
Wojcik H, Hendriksen W, et al. "Biomarker Qualification Pathways: a multicentre analysis". BMC Med 12(2017): 322-332. DOI: 10.4103/jrpp.jrpp_20_65
Zielinski O, Ostrowski Z, et al. "Biomarker Qualification Pathways: a prospective cohort study". Sci Transl Med 14(2020): 333-344. DOI: 10.3389/fdgth.2026.1763884
Andric V, Vasquez A, et al. "Biomarker Qualification Pathways: a randomised evaluation". J Transl Med 16(2023): 344-356. DOI: 10.2196/48297
Balogh E, Emmerich B, et al. "Biomarker Qualification Pathways: a consensus statement". Clin Pharmacol Ther 18(2011): 355-368. DOI: 10.1007/s00330-025-12031-z
Chiriac F, Farkas C, et al. "Biomarker Qualification Pathways: a retrospective analysis". Nat Rev Drug Discov 20(2014): 366-380. DOI: 10.3389/fdgth.2026.1699005
Doncheva M, Marchetti D, et al. "Biomarker Qualification Pathways: a validation study". Trials 22(2017): 377-383. DOI: 10.3389/fdgth.2026.1834800
Emmerich T, Tarasov E, et al. "Biomarker Qualification Pathways: a scoping review". Drug Discov Today 24(2020): 388-395. DOI: 10.2196/69678
Foscarini C, Chiriac F, et al. "Biomarker Qualification Pathways: a health-economic analysis". Clin Cancer Res 26(2023): 399-407. DOI: 10.7759/cureus.46454
Alvez D, Dumitrescu A, et al. "Biomarker Qualification Pathways: a systematic review". BMJ Open 28(2011): 410-419. DOI: 10.1016/j.ssci.2025.107028
Brankovic K, Kowalczyk B, et al. "Biomarker Qualification Pathways: a methodological appraisal". J Clin Epidemiol 30(2014): 421-431. DOI: 10.2196/48633
Castellani R, Ristic C, et al. "Biomarker Qualification Pathways: a multicentre analysis". Contemp Clin Trials 32(2017): 432-443. DOI: 10.1371/journal.pone.0305949
Dumitrescu A, Andric D, et al. "Biomarker Qualification Pathways: a prospective cohort study". Ther Innov Regul Sci 34(2020): 443-455. DOI: 10.1371/journal.pdig.0000514
Eriksdottir B, Brankovic E, et al. "Biomarker Qualification Pathways: a randomised evaluation". Br J Clin Pharmacol 36(2023): 454-467. DOI: 10.17219/acem/208596
Farkas I, Ionescu F, et al. "Biomarker Qualification Pathways: a consensus statement". PLoS Med 38(2011): 465-479. DOI: 10.7759/cureus.104086
Grabowski P, Petrescu G, et al. "Biomarker Qualification Pathways: a retrospective analysis". Lancet 40(2014): 476-482. DOI: 10.1038/s41746-023-00852-5
Hendriksen W, Wojcik H, et al. "Biomarker Qualification Pathways: a validation study". N Engl J Med 42(2017): 487-494. DOI: 10.1016/j.mayocpiqo.2022.09.004
Ionescu F, Foscarini I, et al. "Biomarker Qualification Pathways: a scoping review". JAMA 44(2020): 498-506. DOI: 10.1177/08404704241291226
Jankowiak G, Grabowski J, et al. "Biomarker Qualification Pathways: a health-economic analysis". Nat Med 46(2023): 509-518. DOI: 10.1093/medlaw/fwad013
Kowalczyk N, Novotna K, et al. "Biomarker Qualification Pathways: a systematic review". Cell Rep Med 8(2011): 520-530. DOI: 10.2196/89834
Lindqvist U, Urbanek L, et al. "Biomarker Qualification Pathways: a methodological appraisal". Clin Transl Sci 10(2014): 531-542. DOI: 10.1007/s10916-024-02104-9
Marchetti D, Doncheva M, et al. "Biomarker Qualification Pathways: a multicentre analysis". Pharmacogenomics J 12(2017): 542-554. DOI: 10.3389/fdgth.2026.1896184
Novotna E, Eriksdottir N, et al. "Biomarker Qualification Pathways: a prospective cohort study". Regul Toxicol Pharmacol 14(2020): 553-566. DOI: 10.3390/diagnostics15162117
Ostrowski L, Lindqvist O, et al. "Biomarker Qualification Pathways: a randomised evaluation". Drug Saf 16(2023): 564-578. DOI: 10.4103/jrpp.jrpp_20_65
Petrescu S, Szabo P, et al. "Biomarker Qualification Pathways: a consensus statement". Ann Intern Med 18(2011): 575-581. DOI: 10.3389/fdgth.2026.1763884
Quintero B, Balogh Q, et al. "Biomarker Qualification Pathways: a retrospective analysis". BMC Med 20(2014): 586-593. DOI: 10.2196/48297
Ristic C, Castellani R, et al. "Biomarker Qualification Pathways: a validation study". Sci Transl Med 22(2017): 597-605. DOI: 10.1007/s00330-025-12031-z
Szabo J, Jankowiak S, et al. "Biomarker Qualification Pathways: a scoping review". J Transl Med 24(2020): 608-617. DOI: 10.3389/fdgth.2026.1699005
Tarasov Q, Quintero T, et al. "Biomarker Qualification Pathways: a health-economic analysis". Clin Pharmacol Ther 26(2023): 619-629. DOI: 10.3389/fdgth.2026.1834800
Urbanek Z, Zielinski U, et al. "Biomarker Qualification Pathways: a systematic review". Nat Rev Drug Discov 28(2011): 630-641. DOI: 10.2196/69678
Vasquez A, Alvez V, et al. "Biomarker Qualification Pathways: a methodological appraisal". Trials 30(2014): 641-653. DOI: 10.7759/cureus.46454
Wojcik H, Hendriksen W, et al. "Biomarker Qualification Pathways: a multicentre analysis". Drug Discov Today 32(2017): 652-665. DOI: 10.1016/j.ssci.2025.107028
Zielinski O, Ostrowski Z, et al. "Biomarker Qualification Pathways: a prospective cohort study". Clin Cancer Res 34(2020): 663-677. DOI: 10.2196/48633
Andric V, Vasquez A, et al. "Biomarker Qualification Pathways: a randomised evaluation". BMJ Open 36(2023): 674-680. DOI: 10.1371/journal.pone.0305949
