Meeting of the Ethics Committee for Research involving Medicines and Medical Devices

CEIM Meeting

Meeting of the Ethics Committee for Research involving Medicines and Medical Devices


Meeting of the Ethics Committee for Research involving Medicines and Medical Devices

CEIm Meeting

Meeting of the Ethics Committee for Research involving Medicines and Medical Devices


Meeting of the Ethics Committee for Research involving Medicines and Medical Devices

CEIm Meeting

Meeting of the Ethics Committee for Research involving Medicines and Medical Devices


Meeting of the Ethics Committee for Research involving Medicines and Medical Devices

CEIm Meeting

Meeting of the Ethics Committee for Research involving Medicines and Medical Devices


It will allow Cantabria to implement pilot initiatives to promote healthier environments and reduce social inequalities

 

The EU recently approved a proposal for a Joint Action for the prevention of Cancer and other Non Communicable Diseases (NCDs) with an amount of 75 million euros, which makes it a landmark initiative in public health. A project in which more than 20 EU member states participate together with Norway, the coordinating country, Iceland and Ukraine. Cantabria, Valencia, Catalonia and the Food Safety and Nutrition Agency of the Ministry of Health are the communities and entities participating on the Spanish side.

The aim of this Joint Action is to support strategies and policies designed to reduce the burden of cancer and other NCDs, diseases that constitute a large proportion of the total burden of disease in Europe, much of which can be prevented with appropriate policies.

The objectives of this initiative are:

– To improve the joint capacities of Member States to plan and implement policies and activities for the prevention of cancer and other NCDs at national, regional and local levels.

– Improve the data and monitoring system for cancer and other NCDs and their common risk factors.

– Contribute to the reduction of social inequalities in cancer and other NCDs.

– Engage and support key stakeholders in the field of cancer and NCD prevention, including decision makers at all levels of government, civil society organizations, professionals, the general population and patient groups to facilitate cooperation and joint efforts.

The IDIVAL Research Institute will lead the work on behalf of Cantabria, bringing together the participation of other health institutions, such as the Ministry of Health of the Government of Cantabria, the Cantabrian Health Service, the Marqués de Valdecilla University Hospital and others.

 

The IDIVAL Research Institute will lead the work on behalf of Cantabria, bringing together the participation of other health institutions, such as the Ministry of Health of the Government of Cantabria, the Cantabrian Health Service, the Marqués de Valdecilla University Hospital and others.

The region of Cantabria will receive around 850,000 € to develop several pilots within the work packages WP6 Healthy environments, WP7 on social inequalities and WP10 on identification of individuals at risk and will participate in the cross-cutting work packages of communication and dissemination and evaluation and sustainability.

Joint Action will have a duration of four years and will officially start in January 2024, followed by a kick-off meeting in February in Oslo, Norway. This initiative provides participating countries with a real impact on the development of public health policies in the EU and the strengthening of collaboration within the region.

IDIVAL participates in an international project on public health

It will allow Cantabria to implement pilot initiatives to promote healthier environments and reduce social inequalities   The EU recently approved a proposal for a Joint Action for the prevention of Cancer and other Non Communicable Diseases (NCDs) with an amount of 75 million euros, which makes it a landmark initiative in public health. A […]


The results of the largest European prospective multicenter study on the surgical treatment of right colon cancer have been published.

 

The MIRCAST study, an International multicenter project led for the whole of Europe from the IDIVAL Institute, was born in 2018 with the aim of evaluating the different ways of performing intestinal anastomosis after minimally invasive right colectomy and to determine whether robotic instruments can contribute something in these procedures.

A minimally invasive approach is commonly used in right colectomy, and studies show a reduction in complications, blood loss and reduced hospital stay compared to an open approach. However, controversy remains as to whether robotic assistance is advantageous for this technique or not and whether an intracorporeal (ICA) or extracorporeal anastomosis (ECA) is better.

MIRCAST arose precisely with the aim of shedding light in this field and prospectively evaluating postoperative recovery, hospital stay, wound complications, severe complications and mid-term outcomes (hernia, recurrence …) of minimally invasive right colectomy, comparing intracorporeal with extracorporeal anastomosis and comparing conventional and robotic laparoscopic instruments.

For this purpose, a prospective, international, multicenter, 4-parallel cohort study was designed (robotic right colectomy with ACI, robotic right colectomy with RCT, laparoscopic right colectomy with ACI and laparoscopic right colectomy with RCT) in which 59 hospitals from 12 European countries participated. A total of 1,320 patients from all over Europe were included in the study.

Recently researchers from the MIRCAST Project have published in the British Journal of Surgery the results of the perioperative period revealing that there were no differences in the composite outcome of surgical wound infections and serious postoperative complications between intracorporeal versus extracorporeal anastomosis or laparoscopic versus robotic-assisted surgery. A significantly lower rate of complications was observed in the group of patients treated with AIC. The robotic approach had a significantly lower rate of postoperative ileus and a significantly higher number of resected nodes.

 

These results highlight the advantages for patients when managed by robotic minimally invasive surgery and AIC.

The MIRCAST study is still ongoing and is currently collecting mid-term data from patients who have already undergone surgery, which will allow us to see the impact on quality of life of the different techniques and the oncologic outcomes of the different approaches.

 

Ref: Early outcomes from the Minimally Invasive Right Colectomy Anastomosis study (MIRCAST). Gómez Ruiz M, Espin-Basany E, Spinelli A, Cagigas Fernández C, Bollo Rodriguez J, María Enriquez Navascués J, Rautio T, Tiskus M; MIRCAST STUDY GROUP. Br J Surg. 2023 Jun 8:znad077. doi: 10.1093/bjs/znad077. Online ahead of print. PMID: 37289913

 


Each call has a budget of 30 million euros to finance health research and innovation projects

 

On July 27th, the ISCIII opened the FORTALECE call for Health Research Institutes and the ISCIII Platforms call for support for R&D&I in Biomedicine and Health Sciences. Each call has a funding of 30 million €.

 

FORTALECE Call for Health Research Institutes accredited by the ISCIII

The FORTALECE call addressed to Health Research Institutes (IIS) of the Instituto de Salud Carlos III (ISCIII) is the first representation of FORTALECE, a new global program of science funding, more flexible and less bureaucratic, which seeks to consolidate and promote research groups in Spain and which will be developed over the next decade.

FORTALECE is intended to finance projects developed in Health Research Institutes (IIS) accredited by the ISCIII. It will have 30 million to finance during this year a forecast of 72 research groups from different IIS, so that each selected group will receive an average of 100,000 euros per year on the first day of the year, a stable funding for four years to develop their main lines of work.

To apply for grants, ISCIII-accredited IIS research groups must explain what their proposal consists of, explain its development, define the scientific strategy of the project and specify how the funds received will be used. The form should include, in general terms, a brief narrative description of the proposal and the expected incentive effect on the lines of research, the definition of the chosen groups, the specific clinical-health care issues to be solved, and the development of the frontier science expected to be obtained.

Call for applications (link)

More information (link)

The deadline for applications begins on July 27 and ends on September 12.

 

Call for ISCIII Platforms to support R&D&I in Biomedicine and Health Sciences

This 2023 call for R&D&I support platforms in Biomedicine and Health Sciences will consolidate the activity of the ISCIII Platform for Clinical Research Support (SCREN), the ISCIII Platform for Biomodels and Biobanks (PNBB) and the ISCIII Platform for Dynamization and Innovation of the industrial capacities of the NHS and their effective transfer to the productive sector (ITEMAS). It will have 30 million for the next three years (2023-2025), with annual grants of 10 million.

Call for proposals (link)

More information (link)

The deadline for applications begins on July 27 and ends on September 12.

 


Meeting of the Ethics Committee for Research involving Medicines and Medical Devices6

CEIm meeting

Meeting of the Ethics Committee for Research involving Medicines and Medical Devices6


Meeting of the Ethics Committee for Research involving Medicines and Medical Devices

CEIm Meeting

Meeting of the Ethics Committee for Research involving Medicines and Medical Devices


Ankle fractures are the third most frequent cause of total fractures and generate functional alterations in the short and long term.

 

Ankle fractures are the third most frequent cause of fractures in all ages. Surgical treatment and the period of immobilization generate important functional alterations in the short and long term such as pain, stiffness, reduced range of motion (ROM), loss of proprioception or muscle weakness.

These functional alterations are the basis of the study of the research project “Functional assessment of the Plantar Achilles Calcaneal System (SACP) in patients after ankle surgery” conducted by researchers from the Gimbernat-Cantabria University School in collaboration with the Department of Traumatology and Orthopedic Surgery of Valdecilla Hospital: Dr. Mario Fernández Gorgojo and Dr. Diana Salas Gómez (EUG); Dr. María Isabel Pérez Núñez and Esther Laguna Bercero (HUMV); Pascual Sánchez Juan of the CIEN Foundation.

The aim of the study was to evaluate in patients with bimalleolar ankle fracture at 6 and 12 months after surgery, the functional limitations quantified by gait analysis, static/dynamic balance, clinical parameters and functionality scales. As a result of this project, 4 scientific articles have been published in impact journals (Sensors (2022 and 2023); Gait & Posture (2020); Journal Of Clinical Medicine (2022)).

The last published article “Analysis of dynamic plantar pressure and influence of clinical-functional measures on their performance in subjects with bimalleolar ankle fracture at 6 and 12 months post surgery” (SENSORS; 2023) analyzed dynamic plantar pressure and functional status in patients with bimalleolar ankle fracture at 6 and 12 months after surgery; and the degree of correlation with previously collected clinical variables. A total of 22 subjects with bimalleolar ankle fracture and 11 healthy subjects were included. Data collection was performed at 6 and 12 months after surgery and included clinical measurements (ankle dorsiflexion range of motion and bimalleolar/calf circumference), functional scales (AOFAS and OMAS) and dynamic plantar pressure analysis using a pressure platform. Significant differences were found between groups in mean/maximal plantar pressure, as well as in contact time at 6 and 12 months (effect size 0.63 ≤ d ≤ 0.97). Furthermore, in the ankle fracture group there is a moderate negative correlation (-0.435 ≤ r ≤ 0.674) between plantar pressures (mean and maximum) with bimalleolar and calf circumference. The AOFAS and OMAS scale scores increased at 12 months to 84.4 and 80.0 points, respectively. The study reflects that despite the evident improvement one year after surgery, the data collected using the pressure platform and functional scales suggest that recovery is not yet complete.

Following the results obtained in this research and after reviewing the existing literature, future objectives are to conduct clinical trials with a specific intervention program that would include therapies aimed at gaining joint range, strength programs and functional gait, balance or stair climbing tasks. Furthermore, in view of the functional deficits produced by this type of fracture in both the short and long term, the intervention programs should be more prolonged, individualized and with a follow-up of at least 1 year (including home work).

Ref. Analysis of Dynamic Plantar Pressure and Influence of Clinical-Functional Measures on Their Performance in Subjects with Bimalleolar Ankle Fracture at 6 and 12 Months Post-Surgery. Mario Fernández-Gorgojo, Diana Salas-Gómez, Pascual Sánchez-Juan, Esther Laguna-Bercero, María Isabel Pérez-Núñez. Sensors (Basel). 2023 Apr 13;23(8):3975. PMID: 37112316 PMCID: PMC10142754 DOI: 10.3390/s23083975