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Sacristan J.A.,Lilly Spain
BMC Medical Research Methodology | Year: 2015

Background: Despite their close relationship, clinical research and medical care have become separated by clear boundaries. The purpose of clinical research is to generate generalizable knowledge useful for future patients, whereas medical care aims to promote the well-being of individual patients. The evolution towards patientcentered medicine and patient-oriented research, and the gradual standardization of medicine are contributing to closer ties between clinical research and medical practice. But the integration of both activities requires addressing important ethical and methodological challenges. Discussion: From an ethical perspective, clinical research should evolve from a position of paternalistic beneficence to a situation in which the principle of non-maleficence and patient autonomy predominate. The progressive adoption of "patient-oriented informed consent", "patient equipoise", and "altruism-based research", and the application of risk-based ethical oversight, in which the level of regulatory scrutiny is adapted to the potential risk for patients, are crucial steps to achieve the integration between research and care. From a methodological standpoint, careful and systematic observations should have greater relevance in clinical research, and experiments should be embedded into usual clinical practice. Clinical research should focus on individuals through the development of patient-oriented research. In a complementary way, the integration of experiments into medical practice through the systematic application of "point of care research" could help to generate knowledge for the individuals and for the populations. Summary: The integration of clinical research and medical care will require researchers, clinicians, health care managers, and patients to reevaluate the way they understand both activities. The development of an integrated learning health care system will contribute to generating and applying clinically relevant medical knowledge, producing benefits for present and future patients. © 2015 Sacristán; licensee BioMed Central.

Sacristan J.A.,Lilly Spain
BMC Medical Informatics and Decision Making | Year: 2013

Background: Patient-centered medicine is developing alongside the concepts of personalized medicine and tailored therapeutics. The main objective of patient-centered medicine is to improve health outcomes of individual patients in everyday clinical practice, taking into account the patient's objectives, preferences, values as well as the available economic resources. Discussion. Patient-centered medicine implies a paradigm shift in the relationship between doctors and patients, but also requires the development of patient-oriented research. Patient-oriented research should not be based on the evaluation of medical interventions in the average patient, but on the identification of the best intervention for every individual patient, the study of heterogeneity and the assignment of greater value to observations and exceptions. The development of information-based technologies can help to close the gap between clinical research and clinical practice, a fundamental step for any advance in this field. Summary. Evidence-based medicine and patient centered medicine are not contradictory but complementary movements. It is not possible to practice patient-centered medicine that is not based on evidence, nor is it possible to practice evidence-based medicine at a distance from the individual patient. © 2013 Sacristán; licensee BioMed Central Ltd.

Sacristan J.A.,Lilly Spain | Avendano-Sola C.,Hospital Universitario Puerta Of Hierro
International Journal of Clinical Practice | Year: 2015

Three decades ago, John R Hampton announced the death of clinical freedom. Since then, evidence-based medicine has been the predominant paradigm in clinical research. By applying a population-based approach, the randomised controlled trial has become the cornerstone for demonstrating the overall effect of a treatment and for developing guidelines. The new patient-centred medicine movement is rediscovering the important implications of heterogeneity of treatment effects for clinical practice and that a better understanding of such variability can contribute to improve health outcomes for individual patients through practicing a science-based clinical freedom. © 2015 The Authors. International Journal of Clinical Practice Published by John Wiley & Sons Ltd.

Tinahones F.J.,CIBER ISCIII | Onaca A.,Pelican Hospital of Oradea | Cleall S.,Eli Lilly and Company | Rodriguez A.,Lilly Spain
Diabetes, Obesity and Metabolism | Year: 2014

Aims: To compare the efficacy and safety of two insulin intensification strategies in patients with type 2 diabetes inadequately controlled on basal insulin glargine with metformin and/or pioglitazone. Methods: A multinational, randomized, open-label trial that compared insulin lispro low mixture (LM25; n=236) twice daily with a basal-prandial regimen of insulin glargine once daily and insulin lispro once daily (IGL; n=240) over 24weeks in patients with HbA1c 7.5-10.5% and fasting plasma glucose =6.7 mmol/l. The primary objective was to assess non-inferiority [per-protocol (PP) population], and then superiority [intention-to-treat (ITT) population], of LM25 versus IGL according to change in HbA1c after 24weeks (non-inferiority margin 0.4%, two-sided significance level 0.05). Results: Estimated change [least squares (LS) mean (95% CI)] in HbA1c after 24 weeks: -1.30 (-1.44, -1.16)% with LM25 and -1.08 (-1.22, -0.94)%with IGL. Non-inferioritywas shown [LSmean (95% CI) HbA1c treatment difference-0.21 (-0.38,-0.04) (PP population)]; gated superiority assessment showed a statistically significant advantage for LM25 (p=0.010; ITT population). Mean blood glucose, glycaemic variability, overall tolerability and hypoglycaemic episodes per patient-year did not show significant differences between treatments during the study. Conclusions: In patients with type 2 diabetes inadequately controlled on once-daily basal insulin glargine and metformin and/or pioglitazone, intensification with LM25 was superior to a basal-prandial approach in terms of reduction in HbA1c after 24 weeks and did not increase hypoglycaemia episodes. © 2014 John Wiley & Sons Ltd.

Blanco R.,Oncology Service | Maestu I.,Hospital Universitario Dr Peset | de la Torre M.G.,Lilly Spain | Cassinello A.,Lilly Spain | Nunez I.,Lilly Spain
Annals of Oncology | Year: 2015

Most patients with non-small-cell lung cancer (NSCLC) are elderly but evidence to guide appropriate treatment decisions for this age group is generally scant. Careful evaluation of the elderly should be undertaken to ensure that treatment appropriate for the stage of the tumour is guided by patient characteristics and not by age. The Comprehensive Geriatric Assessment (CGA) remains the preferred option, but briefer tools may be appropriate to select patients for further evaluation. The predicted outcome should be used to guide management decisions together with a reappraisal of polypharmacy. Patient expectations should also be taken into account. Management recommendations are generally similar to those of general guidelines for the NSCLC population, although the risks of surgery and toxicity of chemotherapy and radiotherapy are often increased in the elderly compared with younger patients; therefore, patients should be closely scrutinised and subjected to a CGA to ensure suitability of the planned treatment. If surgery is indicated, then lobectomy is generally the preferred option, although limited resection may be more feasible for some. Radiotherapy with curative intent is an alternative, with stereotactic body radiotherapy the most likely preferred modality. Adjuvant chemotherapy is also an appropriate approach, whereas adjuvant radiotherapy is generally not recommended. Concurrent chemoradiotherapy should be considered for elderly patients with inoperable locally advanced disease and chemotherapy for advanced/metastatic disease. Efforts should also be made to increase participation of elderly patients with NSCLC in clinical trials, thereby enhancing evidence-based treatment decisions for this majority group. This will require overcoming barriers relating to trial design and to physician and patient awareness and attitudes. © The Author 2014. Published by Oxford University Press on behalf of the European Society for Medical Oncology.

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