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Editorial
. 2020 Sep 1;6(9):1334-1335.
doi: 10.1001/jamaoncol.2020.1847.

What Constitutes a Valid Surrogate End Point in Cancer Clinical Trials?

Yu Shyr  1   2   3 , Derek Shyr  4
Affiliations
Editorial

What Constitutes a Valid Surrogate End Point in Cancer Clinical Trials?

Yu Shyr et al. JAMA Oncol. .
No abstract available

PubMed Disclaimer

Conflict of interest statement

Conflict of Interest Disclosures: None reported.

Comment on

  • Association of Event-Free and Distant Recurrence-Free Survival With Individual-Level Pathologic Complete Response in Neoadjuvant Treatment of Stages 2 and 3 Breast Cancer: Three-Year Follow-up Analysis for the I-SPY2 Adaptively Randomized Clinical Trial.
    I-SPY2 Trial Consortium; Yee D, DeMichele AM, Yau C, Isaacs C, Symmans WF, Albain KS, Chen YY, Krings G, Wei S, Harada S, Datnow B, Fadare O, Klein M, Pambuccian S, Chen B, Adamson K, Sams S, Mhawech-Fauceglia P, Magliocco A, Feldman M, Rendi M, Sattar H, Zeck J, Ocal IT, Tawfik O, LeBeau LG, Sahoo S, Vinh T, Chien AJ, Forero-Torres A, Stringer-Reasor E, Wallace AM, Pusztai L, Boughey JC, Ellis ED, Elias AD, Lu J, Lang JE, Han HS, Clark AS, Nanda R, Northfelt DW, Khan QJ, Viscusi RK, Euhus DM, Edmiston KK, Chui SY, Kemmer K, Park JW, Liu MC, Olopade O, Leyland-Jones B, Tripathy D, Moulder SL, Rugo HS, Schwab R, Lo S, Helsten T, Beckwith H, Haugen P, Hylton NM, Van't Veer LJ, Perlmutter J, Melisko ME, Wilson A, Peterson G, Asare AL, Buxton MB, Paoloni M, Clennell JL, Hirst GL, Singhrao R, Steeg K, Matthews JB, Asare SM, Sanil A, Berry SM, Esserman LJ, Berry DA. I-SPY2 Trial Consortium, et al. JAMA Oncol. 2020 Sep 1;6(9):1355-1362. doi: 10.1001/jamaoncol.2020.2535. JAMA Oncol. 2020. PMID: 32701140 Free PMC article. Clinical Trial.

References

    1. US Food and DrugAdministration. Guidance for industry: pathological complete response in neoadjuvant treatment of high-risk early-stage breast cancer: use as an endpoint to support accelerated approval. Accessed June 22, 2020 https://www.fda.gov/media/83507/download
    1. I-SPY2 Trial Consortium. Association of event-free and distant recurrence-free survival with individual-level pathologic complete response in neoadjuvant treatment of stages 2 and 3 breast cancer: three-year follow-up analysis for the I-SPY2 adaptively randomized clinical trial. JAMA Oncol. Published online July 23, 2020. doi: 10.1001/jamaoncol.2020.2535 - DOI - PMC - PubMed
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