The Spanish Agency of Medicines and Medical Devices (Spanish: Agencia Española de Medicamentos y Productos Sanitarios; AEMPS) is a regulatory and autonomous agency of the Government of Spain that acts as the highest sanitary authority in the country in terms of medical safety on medicines, health products, cosmetics and personal care products.The agency is responsible for the regulation and authorization of clinical trials and the commercialization of sanitary products for human use, the planification and evaluation of those products along with the European Medicines Agency (EMA); the authorization of clinical laboratories, develop the specific rules to ensure the quality of the medical products and inspect all sanitary products of the central government competence. Since 1998, the agency has powers over the control, evaluation and authorization of animal health products.The agency was created under the name of Agencia Española del Medicamento by the Fiscal, Administrative and Social Order Measures Act of 1997 and its powers were extended (to fields such as veterinary drugs) by another law of the same name from 1998 and by the Cohesion and Quality of the National Health System Act of 2003. The statute of the agency was approved in 1999. It was renamed as Agencia Española de Medicamentos y Productos Sanitarios in August 2003. It depends directly from the Ministry of Health.The agency is chaired by a President and a Vice President. Both officials are Under Secretaries of the Ministry of Health and Agriculture. The real chief executive of the agency is the Director.
To use the conventional f_2 method to compare dissolution profiles, at least 3 time points should be included; however, when the bootstrap f_2 method is applied, there are no clear criteria in regulatory guidelines in this regard. The effects of applying the minimum number of time points on the accuracy, precision, type I error (TIE), and statistical power have been investigated in the current study. Four scenarios were simulated where the reference product (R) dissolves at different rates. For each scenario, 17 population dissolution profiles of the test product (T) were simulated with predefined target population f_2 values with different variability and samples sizes. For each bootstrapped data set, the expected f_2 was calculated twice to obtain the 90 3 time points (TP3) or at least 1 time point (TP1). The whole process was repeated 10000 times to evaluate the statistical properties. Effects on TIE and statistical power of TP1 and TP3 are similar for scenario B to D but different for A due to lack of enough time points in the bootstrapped data set. For A, TP3 shows much higher power than TP1, and TIE can be controlled at an acceptable level. It is recommended to calculate the expected f_2 with at least 3 time points for each bootstrapped data set, and there should be enough number of calculable expected f_2 from the bootstrapped samples to obtain 90 is high, sample size should be increased to improve statistical power.
Background and purpose: Chondrosarcoma is a rare bone malignancy with a poor response to systemic therapy in advanced stages. European-level epidemiological data remain scarce. This study aimed to characterise patient demographics, treatments and survival using real-world data to inform regulatory decisions about the feasibility and design of new trials for the systemic treatment of chondrosarcoma. Patient/material and methods: This cohort study, part of the DARWIN EU® initiative, analysed data from six healthcare databases in Finland, France, the Netherlands, Spain and the UK. Patients diagnosed with chondrosarcoma between 2010 and 2022 were identified. Standardised analyses were performed within a federated network using the Observational Medical Outcomes Partnership (OMOP) Common Data Model. Results: A total of 2,498 chondrosarcoma patient records were identified, covering at least 2,356 unique patients. Median age at diagnosis was 52–55 years, with a balanced sex distribution. Surgical treatment was the most common intervention, recorded in 15.2% to 88.9% of patients, depending on the database. Fewer than 5% received systemic anticancer therapy, and radiotherapy was reported in fewer than 7%. The 10-year overall survival (OS) ranged from 58% (95% confidence interval [CI]: 43–78) to 80% (95% CI: 78–82), with restricted mean survival between 7.4 and 8.7 years. In the Netherlands, patients with late-stage, metastatic or high-grade disease showed significantly poorer outcomes. Interpretation: This study demonstrates the feasibility of using real-world data across Europe to describe chondrosarcoma patients. Most had early-stage, low-grade disease amenable to surgery, with limited use of systemic therapies. Survival was generally favourable, except in advanced disease. Clinical trials remain difficult due to the rarity of advanced chondrosarcoma and the lack of standards.
La participación de pacientes y ciudadanos en la investigación contribuye a mejorar la relevancia de los estudios, aunque su presentación en la literatura es inconsistente y poco clara. Para mejorar la transparencia y la calidad de esta participación se desarrollaron las guías GRIPP2 (Guidance for Reporting Involvement of Patients and the Public), que ofrecen orientación específica para una presentación sistemática y transparente. Esta nota metodológica describe la adaptación y traducción al español de dichas guías, con el objetivo de fomentar la calidad, la coherencia y la transparencia en la evidencia sobre la participación de pacientes y ciudadanos en la investigación. Se presentan dos versiones: GRIPP2 formulario largo, con 34 ítems orientados a estudios en los que la participación de pacientes y ciudadanos es el foco principal, y GRIPP2 formulario corto, con 5 ítems para estudios en los que esta participación es un componente secundario. Las guías están dirigidas fundamentalmente a investigadores y autores que quieran incorporar la participación de pacientes y ciudadanos en sus investigaciones, así como a revisores y editores de revistas. Además, también pueden ser de interés para responsables de políticas de investigación, agencias financiadoras, agencias de evaluación de tecnologías sanitarias y, por supuesto, pacientes y ciudadanos.
Patient and public involvement in research contributes to improving the relevance of studies, although its reporting in the literature is inconsistent and lacks clarity. To enhance the transparency and quality of this involvement, the GRIPP2 (Guidance for Reporting Involvement of Patients and the Public) guidelines were developed, providing specific guidance for systematic and transparent reporting. This methodological note describes the adaptation and translation of these guidelines into Spanish, with the aim of promoting quality, consistency, and transparency in the evidence on patient and public involvement in research. Two versions are presented: GRIPP2 long form, with 34 items aimed at studies where patient and public involvement is the primary focus, and GRIPP2 short form, with 5 items for studies where involvement is a secondary component. The guidelines are primarily intended for researchers and authors wishing to incorporate patient and public involvement in their research, as well as for reviewers and journal editors. Additionally, they may be of interest to research policy makers, funding agencies, health technology assessment bodies, and, of course, patients and the public.
Osteoporosis and osteoarthritis are key diseases of musculoskeletal ageing and are increasing in prevalence and burden with the progressively ageing population worldwide. These conditions are thus particularly common in 'the oldest old', and there are complexities of managing them within the context of extensive multimorbidity, physical and mental disability, and polypharmacy, the rates for all of which are high in this population. In this narrative review, we explore the epidemiology of osteoporosis and osteoarthritis in the oldest old before examining trials and real-world data relating to the pharmacological treatment of these diseases in older adults, including anti-resorptives and bone-forming agents in osteoporosis and symptomatic slow-acting drugs for osteoarthritis, paracetamol, and non-steroidal anti-inflammatory drugs in osteoarthritis, recognising that the oldest old are usually excluded from clinical trials. We then review the potential benefits of nutritional interventions and exercise therapy before highlighting the health economic benefits of interventions for osteoporosis and osteoarthritis. The high prevalence of risk factors for both disease and adverse events associated with treatment in the oldest old mean that careful attention must be paid to the potential benefits of intervention (including fracture risk reduction and improvements in osteoarthritis pain and function) versus the potential harms and adverse effects. Further direct evidence relating to such interventions is urgently needed from future research.
