BackgroundPatient engagement is an essential aspect in the research/development of biopharmaceutical products and disease management. Improving the lives of patients requires a deep understanding of their medical conditions, experiences, needs and priorities. However, a consistent definition of patient centricity is lacking. A series of initiatives was conducted to define patient centricity and its important principles impacting the biopharmaceutical industry.MethodsInterviews, questionnaires and literature reviews were conducted involving key stakeholders to initially identify issues of importance to patients, healthcare providers and payers. Subsequently, two identical workshops which included 22 patients/carers created a definition of patient centricity and the healthcare values important to patients/caregivers. Outputs were tested in a validation exercise involving patients in predominantly US (n=470) and European (n=703) patient forums.ResultsInitial research provided deeper understanding of patient needs and key topics of interest that were used to cocreate a definition of patient centricity and 10 associated principles of importance to the biopharmaceutical industry. Wider testing of these outputs among predominantly US/European patient communities confirmed their validity. Patient centricity should be defined as ‘Putting the patient first in an open and sustained engagement of the patient to respectfully and compassionately achieve the best experience and outcome for that person and their family’. Important principles for patients focused on education/information, cocreation, access and transparency.ConclusionsThe development of a consistent definition of patient centricity and its associated principles provides an opportunity for biopharmaceutical companies to adopt and use these as a reference point for consistent patient engagement throughout the product life cycle.
Background: Monocyte activation in cancer patients may be reflective of anticancer activity. However, studies indicate that recruitment of macrophages can actually promote tumor growth and angiogenesis. Assessment of other microenvironmental cells such as circulating endothelial cells (CECs) may provide additional information regarding disease progression. The objective of this study was to assess monocyte activation and CECs in breast cancer patients and determine the potential clinical relevance during disease progression.Methods: Patients (n = 41) with localized or metastatic breast cancer who were not currently receiving treatment were eligible for study inclusion. Peripheral blood was collected and analyzed by flow cytometry for monocyte activation (Leuko64 TM assay kit), and for CECs (CD146 + CD45 2 phenotype).Results: Metastatic breast cancer patients demonstrated a higher monocyte CD64 index relative to normal donors and localized breast cancer patients (P < 0.05). Furthermore, breast cancer patients had a lower monocyte CD163 index relative to normal donors (P = 0.008). Localized breast cancer patients demonstrated higher levels of CD146 + CD45 2 cells CECs relative to metastatic breast cancer patients and normal donors. Within the localized breast cancer population, levels of CD146 + CD45 2 cells increased with disease stage (P < 0.05).Conclusions: These results suggest that monocyte activation and CECs may play a role in breast cancer progression. We speculate that monocyte activation may reflect a reaction to metastatic cells and/or response to tissue damage caused by metastatic growth in distant organs. Furthermore, the observation that CECs increase with disease stage in localized breast cancer suggests that CECs could be a useful surrogate marker for disease progression in this patient population. q
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