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. 2025 Jul 10;11(1):71.
doi: 10.1038/s41523-025-00768-1.

Advancing equitable access to innovation in breast cancer

Seamus O'Reilly  1 , Ines Vaz Luis  2 , Virginie Adam  3 , Evangelia D Razis  4 , Ander Urruticoechea  5 , Amal Arahmani  3 , Eva Carrasco  6 , Boon H Chua  7 , Judith Bliss  8 , Carolyn Straehle  3 , Theodora Goulioti  3 , Barbro Lindholm  9 , Gustavo Werustsky  10 , Etienne Brain  11 , Philippe L Bedard  12 , Giuseppe Curigliano  13 , Sherene Loi  14 , Shigehira Saji  15 , David Cameron  16
Affiliations

Advancing equitable access to innovation in breast cancer

Seamus O'Reilly et al. NPJ Breast Cancer. .

Abstract

This manuscript critically examines the challenges associated with the design and conduct of academic global breast cancer trials outside the influence of pharmaceutical companies, leveraging insights from the Breast International Group (BIG). In the past 4 decades significant declines in breast cancer mortality have occurred, partly related to industry-academic clinical and translational partnerships with long term study follow up. However, in the past decade these partnerships have largely uncoupled. The increasing complexity and non-alignment of trials, funding constraints, regulatory complexity, declining academic freedom, lack of transparency, and lack of affordability of new agents have become key barriers to equitably improving cancer outcomes. Industry research expenditure in the United States is now 5 fold greater than publically funded academic research. To address these challenges, we advocate for patient centred systemic reforms, with trials balancing commercial interests with public health imperatives. These reforms should include equitable research funding models, streamlined international clinical trial regulatory processes, and increased collaboration across diverse stakeholders. Practical solutions to enhance global trial accessibility and efficacy include leveraging digital technologies, artificial intelligence, real world data, decentralizing clinical trial infrastructure, and embedding translational research frameworks across countries.

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Conflict of interest statement

Competing interests: Conflict of Interest Travel: Servier (ER), Gilead (ER, EB) Astra Zeneca (ER, EB, GC) Integris (ER), Pfizer (ER, EB), Genesis Pharma (ER), Bristol Myers Squibb (ER), Roche (ER, GC), Daichi Sankyo (EB, GC, SOR), Exact Sciences (EB), Novartis (EB,IVL, SOR), Merck (SOR), Nordic Pharma (SOR)Stocks: Eli Lilly (EC)Honoraria/Lecture Fees: Chugai (SS), Kyowa Kirin (SS), Merck Sharp Dohme (SS, GW), Takeda (SS, EB), Novartis (SS, GW, ER, EB, GC), Daichi Sankyo (SS, GW, EB,GC,BL), Eisai (SS), Eli Lilly (SS, EB, GC), Astra Zeneca (SS, GW, ER, EB, GC), Pfizer (EB, GC, GW,SS), Taiho (SS), Oho (SS), Nippon Kayaku (SS), Gilead (SS, ER), Exact Sciences (SS, GC,EB), Myriad Genetics (SS), Roche (GW,GC), Ser-vier (ER), Foundation Medicine (GC), Samsung (GC), Incyte (EB), Seagen (GC), Menarini (GC), Gilead Sciences (GC), Ellipses Pharma (GC).Consultancy/Advisory RolesGlaxo Smith Kline (GC), Zymeworks (PB), Astra Zeneca (GW,GC, BL, SL), Roche (SL, GC), Janssen (PB), Repare (PB), Eli Lilly (GC, SL, BL,PB), Exact Sciences (SL,EB), Gilead Sciences (GC, SL, BL), Amgen (PB), Foundation Medicine (GC), Bristol Myers Squibb (GC,SL), Samsung (GC), Boehringer Ingelheim (GC), Merck (GC, PB), Blueprint Medicines (GC), Sandoz (EB), Pfizer (EB, GC, BL), Menarini (EB, GC, BL), Exnet Science (GC), Daichi Sankyo (GW, EB, BL), Novartis (GW, GC,SL), Merck Sharp Dohme (GW), Seagen (GC,PB), Guardant Health (GC), Celulicity (GC), Hengrini Therapeutics (GC), Amaroq Therpeutics (SL), Mersana Therpeutics (SL), Domain Therpeutics (SL), BioNTech (SL), Menarini Asia Pacific (SL), Bicycle Therpeutics (SL), Saga Diagnostics (SL), Adanate (SL), Research Funding to InstitutionAmgen (PB, IVL), Signal Chem (PB) Seagen (PB), Servier (PB), Sanofi Aventis (SS, PB, AA, VA, TG, CS), Janssen (JB, GW), Clovis (JB), Bristol Myers Squibb (SL, PB), Lilly Loxo (PB), Medice-na (PB), PTC Thereputics (PB), Life Sciences (PB), Zymeworks (PB), Veracyte (BC, PB), Taiho (SS), Eisai (SS), Chugai (SS), Medimmune (GW), Novartis (IVL, SL, DC, GW, EC, AA, VA, TG, CS, JB, PB), Pfizer (DC, SL, GW, EC, AA, VA, CS, TG, JB), Merck Sharp Doehm (SL,JB,SS), Takeda (SS, GW), Astra Zeneca (SL, DC, SS, PB, GW, EC, BL, IVL), Daichi Sankyo (DC,SS), Roche (SL, DC, GW, EC, AA, VA, CS, TG), Merck (GW, GC,PB), Bayer (GW), Astellas (GW), PUMA biotech (JB), Gilead (SL, SS, GC, PB), Eli Lilly (SS, SL, EC, PB), Glaxo Smith Kline (GW, PB, AA, VA, TG, CS), Libos (GW), Boehringer Ingelheim (PB), Greenwich Lifesciences (EC), Nektar (PB), Exact Sciences (DC), Ely Lilly (DC), Menarini (DC), Resilience Care (IVL), Pfizer Edimark (IVL), Sandoz (IVL), Chugai (IVL), Servier Monde (IVL),Doctaform Medical Market-ing (IVL), Nektar Therapeutics (SL),No Conflicts to DeclareAU.

Figures

Fig. 1
Fig. 1. Challenges for breast cancer trials.
Barriers to clinical investigation in breast cancer therapeutics include lack of co-ordination and lack of data sharing between trials, climate toxicity associated with research, entanglement between industry and investigators and growing trial complexity compounded by lack of funding.
Fig. 2
Fig. 2. The use of digital tools in the path for young research pathway (EU funded international chemotherapy de-escalation trial in pre-menopausal women with breast cancer (BC)) – Figure adapted ref. .
The trial includes digital information resources for patients, family members and the general population to improve trial understanding and real-time communication; workshops with patients representatives regarding study procedures, recruitment, results, and monitoring of inclusion metrics with automated alerts relating to the risk of under-representation of patient groups, an equity toolbox to boost and support diverse participation hosted in WeShare, and implicit bias training programs for investigators.
Fig. 3
Fig. 3
Opportunities to Optimise Patient Benefit and Integration in Clinical Trials in Breast Cancer.
See this image and copyright information in PMC

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