@article{nokey,

title = {Understanding the patient journey: Barriers, facilitators, and expectations in joining a chemotherapy de-escalation trial among premenopausal patients with breast cancer},

url = {https://www.sciencedirect.com/science/article/pii/S0960977626000809},

doi = { 10.1016/j.breast.2026.104770},

issn = {0960-9776},

year  = {2026},

date = {2026-03-25},

urldate = {2026-03-25},

journal = {The Breast},

volume = {87},

pages = {11},

abstract = {Background

De-escalation trials aim to balance clinical outcomes and quality of life (QoL), especially for premenopausal women with early breast cancer (BC), who often experience a greater treatment burden affecting their physical and psychosocial well-being. We sought to understand their patient journey—barriers, facilitators, and expectations—when joining de-escalation trials to inform patient-centered design and implementation.



Methods

OPTIMA-YOUNG, an EU-co-funded international trial, investigates a genomic assay-guided approach to de-escalate chemotherapy in premenopausal patients with early-stage hormone receptor (HR) + BC. A Co-creation Board of patients and healthcare professionals (HCPs) ensured stakeholder involvement throughout the trial. Focus groups (FGs) explored decision-making, needs, and QoL priorities related to joining a de-escalation clinical trial. Discussions were recorded, transcribed, anonymized, and analyzed using MAXQDA software.



Results

The three FGs included 20 participants (11 patients, 9 HCPs) from 14 countries. Three themes emerged: 1) emotional and cognitive responses to BC diagnosis/treatment; 2) environmental, HCP, and social influences on choices; 3) coping with side effects and QoL challenges. Barriers to joining a de-escalation trial included limited emotional support at diagnosis, cross-country variations in shared decision-making, poor communication on long-term side effects, fear of recurrence, and HCPs’ tendency to overtreat younger patients. Developing training for patients and HCPs was seen essential for improving communication, shared decision-making skills, and enhancing symptom management and QoL.



Conclusions

This pre-implementation study identified factors at the patient, HCP, and system levels that, if addressed, could improve the trial experience. Insights helped refine the OPTIMA-YOUNG protocol and implementation plan and may inform future de-escalation trials.

},

note = {Source: This research is part of the Path-for-Young EU-funded project.},

keywords = {Clinical Development / Trials, Patient Involvement},

pubstate = {published},

tppubtype = {article}

}

@article{nokey,

title = {The READI European project: Enhancing inclusivity in  clinical research},

url = {https://onlinelibrary.wiley.com/doi/10.1111/eci.70146},

doi = {10.1111/eci.70146 },

year  = {2025},

date = {2025-10-28},

urldate = {2025-10-28},

journal = {European Journal of Clinical Investigation},

volume = {56},

note = {Source: It is produced within the READI project consortium.},

keywords = {Clinical Development / Trials, Inclusion and Representativeness in Clinical Research},

pubstate = {published},

tppubtype = {article}

}

@article{nokey,

title = {Lessons learnt from developing an ethnically diverse patient and public involvement group for breast cancer research},

url = {https://bmjopen.bmj.com/content/15/3/e091888},

doi = {10.1136/bmjopen-2024-091888},

year  = {2025},

date = {2025-03-03},

urldate = {2025-03-03},

journal = {BMJ Open},

volume = {15},

abstract = {Objective: There is evidence that those who typically contribute to patient and public involvement (PPI) activities do not reflect the diversity of the population, and individuals from underserved groups are less likely to participate in healthcare research. For some researchers, understanding how to embed diversity into their PPI work can be confusing and challenging. The aim of this communication article is to reflect on our experiences and share the lessons learnt from developing an ethnically diverse PPI group to co-deliver breast cancer research.



Key points: Researchers must be realistic about timelines at both the grant application stage and during the research project, as finding contributors for inclusive and diverse PPI work takes time. Researchers will benefit from utilisation of existing expertise and resources within existing PPI teams at research institutions. It is vitally important to be clear about what researchers need in terms of contributors and what the PPI activities will be at different stages of the research project.



Conclusions: Conducting effective, diverse and meaningful PPI is a research skill that needs to be learnt and practised just like any other. Well-developed inclusive PPI has significant benefits for both researchers and the public.},

note = {Source: BMJ Open},

keywords = {Inclusion and Representativeness in Clinical Research, Patient Involvement},

pubstate = {published},

tppubtype = {article}

}

@article{nokey,

title = {Embedding patient engagement in the R&D process of a life sciences company through co-creation with a patient expert R&D board: a case study},

url = {https://link.springer.com/article/10.1186/s40900-024-00631-w},

doi = {10.1186/s40900-024-00631-w},

issn = {2056-7529},

year  = {2024},

date = {2024-11-06},

urldate = {2024-11-06},

journal = {Research Involvement and Engagement},

volume = {10},

number = {116},

pages = {17},

abstract = {Patient involvement is crucial in healthcare, a factor increasingly recognised by life sciences companies and research institutes. This article presents a case study on Servier, a life sciences company that founded a patient expert board, ahead of launching a new research and development (R&D) institute. The aim was to foster a patient-centric culture within the company. The case study explores key developments in patient and public involvement, emphasising a shift from paternalistic to patient-centred approaches, noting few available case studies on patient board collaborations in life sciences. It outlines the evolution of the board, its impact, and practical lessons learned, with related recommendations. The patient board resulted from a three-way collaboration between the company, Patvocates (a patient consultancy), and patient experts recruited. The patient consultancy played a crucial role in project management, governance, and facilitating relationships. The case study provides the context, timeframe, foundations laid, engagement of patient experts, and foundational values, including: co-creation, fair market value remuneration, voluntary participation, and patient-centric meeting protocol. Eighteen patient experts, representing ten disease areas and ten European countries, joined the board and helped prioritise and co-create projects. Ideas for activities were sourced from brainstorming sessions and an in-company challenge. The collaboration yielded five core ideas, each forming a working group. The study describes the groups and their outputs: a patient advisory council, an interactive gallery of patient experience in R&D, patient engagement and entrepreneurship in life sciences, creating patient-focused decentralised trials (DCTs), and staff training on patient engagement. The article emphasises how the organic evolution of the collaboration led to significant insights. Hurdles faced by the company included: upstream planning, cross-company buy-in, compliance, and internal resource allocation. Recommendations for the wider community included: identifying and contracting patient partners; clarifying roles; managing expectations; building trust; logistics; and sustainability. This case study presents a practical, positive example of patient engagement within a life sciences company, offering insights into the establishing, running, and the impact of collaborating with a patient expert board. Lessons learned and recommendations may serve as a model for other companies seeking to engage with patients and evolve towards a more patient-centric approach in their strategies.},

note = {Source: Springer Nature },

keywords = {Patient Engagement Case Studies},

pubstate = {published},

tppubtype = {article}

}

@article{nokey,

title = {Patient engagement in drug development: dialogically problematizing participation},

url = {https://www.tandfonline.com/doi/full/10.1080/09505431.2024.2410719},

doi = {10.1080/09505431.2024.2410719},

year  = {2024},

date = {2024-10-28},

journal = {Science as Culture},

volume = {34},

number = {1 },

pages = {31–51},

abstract = {For many years, the field of drug development remained insulated from patient engagement initiatives that became commonplace in healthcare, it is currently experiencing a participatory turn. This has been informed by a re-evaluation of the patients' insights and of the roles they can play in drug development, with both democratising and technocratic arguments invoked in support of their more substantial engagement. This article problematises the democratising potential of drug development through a knowledge co-production process between the authors of this paper - two scholars and two practitioners in this field. It scrutinises what patients can participate in drug development by zooming in on the Patient Expert Training provided by EUPATI, arguably the most influential and reputable patient education provider in Europe currently. Through their dialogue, the authors highlight the considerable epistemic requirements placed upon patients and warn about the risk of the emergence of participatory practices that rely exclusively on a narrow patient elite. They also reflect upon the benefits and challenges of close collaborations between researchers and practitioners and call for the systemic transformations needed for such knowledge co-production initiatives to become commonplace in academia.},

note = {Source: Taylor & Francis Online (tandfonline.com)},

keywords = {Pharmaceutical Development},

pubstate = {published},

tppubtype = {article}

}