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Centro Hospitalar Universitário de Santo António

Centro Hospitalar Universitário de Santo António

Institution Description

Centro Hospitalar Universitário de Santo António (CHUdSA) is one of Portugal’s leading university hospitals, covering all fields of health, teaching, and research. The hospital center is structured as a campus, supported by Hospital de  Santo  António, devoted  to  multisystem  and infectious disorders, Centro Materno-Infantil do Norte, dedicated to women and child health, Centro de Genética Médica, specialized in genetic disorders, and Hospital Magalhães Lemos, in the provision of psychiatric and mental health care. CHUdSA has an installed capacity for 848 beds, 46 Day Hospital beds, 35 surgical rooms, and 32 Intensive Care Unit beds. It is the affiliate hospital of the Master in Medicine of ICBAS, University of Porto, and offers internships in all medical specialties. The Department of Education, Training, and Research (DEFI) of CHUdSA supports clinical researchers working in partnership with the academia, funding agencies, and industry. DEFI manages 130 clinical trials of pharmaceutical products and medical devices and observational studies per year, providing coordination, funding, and budget, with the aim of offering patients the opportunity to participate in high-quality clinical research, with emphasis on interventional studies. CHUdSA is a partner of the Portuguese Clinical Research Infrastructure Network (PtCRIN), connected to its European counterpart ECRIN. The hospital centre’s level of specialization, high competency in clinical care, and research capacity, resulted in the implementation of sixteen national reference centres and in the inclusion of CHUdSA in eleven European networks of rare diseases.


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General Indicators
No. of active clinical studies by study type
  • 135
    Active Clinical Trials
  • 46
    Active Non-Interventional Studies
Np. of initiated clinical studies by type of study
  • 44
    Initiated clinical trials
  • 0
    Non-interventional initiated studies
No. of active non-interventional clinical studies by sponsor type
No. of active Clinical trials by sponsor type
No. of active clinical trials per phase
No. of active clinical trials by trial object
  • 1447
    No. of publications in indexed journals - last 5 full years
Global Capability Indicators
  • 839
    No. of available beds in the institution
  • 1.267
    No. of Physicians in the Institution
  • 1.574
    No. of Nurses in the Institution
  • 28
    No. of Pharmacists in the Institution
  • 3.317.773
    No. of Inhabitants covered by the institution
Human Resource Indicators
Total number of people dedicated to clinical research in the institution
  • 731
    Researchers
  • 9
    Study coordinators
  • 6
    Pharmacists
Efficiency Indicators
  • 0
    Average recruitment rate per clinical trial / clinical trial with medical device intervention
  • 0
    Average time to recruit the first patient and clinical studies with medical device intervention
  • 120
    Average time between submission and approval of the Financial Contract in clinical trials and interventional clinical studies of medical devices
General Indicators
No. of active clinical studies by study type
  • 126
    Active Clinical Trials
  • 48
    Active Non-Interventional Studies
Np. of initiated clinical studies by type of study
  • 38
    Initiated clinical trials
  • 10
    Non-interventional initiated studies
No. of active non-interventional clinical studies by sponsor type
No. of active Clinical trials by sponsor type
No. of active clinical trials per phase
No. of active clinical trials by trial object
  • 1217
    No. of publications in indexed journals - last 5 full years
Global Capability Indicators
  • 848
    No. of available beds in the institution
  • 1223
    No. of Physicians in the Institution
  • 1543
    No. of Nurses in the Institution
  • 34
    No. of Pharmacists in the Institution
  • 3.317.773
    No. of Inhabitants covered by the institution
Human Resource Indicators
Total number of people dedicated to clinical research in the institution
  • 634
    Researchers
  • 14
    Study coordinators
  • 7
    Pharmacists
Efficiency Indicators
  • 59,4%
    Average recruitment rate per clinical trial / clinical trial with medical device intervention
  • 110 days
    Average time to recruit the first patient and clinical studies with medical device intervention
  • 170 days
    Average time between submission and approval of the Financial Contract in clinical trials and interventional clinical studies of medical devices

Clinical Research Areas of interest

Clinical Research Areas of interest

  • Neurosciences, Immunology, Ophthalmology
  • Oncology, Hematology
  • Systemic, Infectious, Kidney and Amyloidosis Diseases
  • Human Genetics, Rare Diseases of Metabolism
  • Organ Transplantation
  • Hepatobiliary and Colon Surgery
  • Intensive Care and Anesthesiology

Certifications

Certifications

  • Casper Healthcare Knowledge Systems (CHKS) Accreditation

Gallery

Hospital

Hospital

Working Group Participation

European Networks

ERN on Metabolic Diseases - MetabERN
CHUdSA coordinator | Esmeralda Martins

ERN on Transplantation in Children - ERN TRANSPLANT - CHILD
CHUdSA coordinator | Conceição Mota

ERN on Respiratory Diseases ERN-LUNG
CHUdSA coordinator | Abílio Reis

ERN for Epilepsies - EpiCare
CHUdSA coordinator | Rui Rangel

ERN for Rare Adult Cancers (Solid Tumors) - ERN EURACAN
CHUdSA coordinator | António Araújo

ERN on Rare Hematological Diseases - EuroBloodNet
CHUdSA coordinator | Graça Porto

ERN for Rare Kidney Diseases - ERKNet 
CHUdSA coordinator | Alberto Caldas Afonso e Conceição Mota

ERN for Rare Immunodeficiencies and Rare Autoinflammatory and Autoimmune Diseases -  ERN-RITA
CHUdSA coordinator | Fátima Farinha e Raquel Faria

ERN for Rare Neuromuscular Diseases - ERN EURO-NMD
CHUdSA coordinator | Manuela Almeida Santos

ERN on Connective Tissue and Musculoskeletal Diseases - ReCONNET
CHUdSA coordinator | Fátima Farinha e Raquel Faria

ERN on COVID-19 - Rare and infectious diseases

National Reference Centers

Adult Oncology - Esophageal Cancer

Refractory Epilepsy

Cystic Fibrosis

Hereditary Metabolic Diseases

Adult Oncology - Testicular Cancer: Portuguese Institute of Oncology of Porto, Francisco Gentil, E. P. E. in inter-institutional collaboration with Centro Hospitalar Universitário do Porto, E. P. E

Adult Oncology - Bone and Soft Tissue Sarcomas

Adult Oncology - Rectal Cancer

Adult Oncology - Hepatobilio-Pancreatic Cancer

Pediatric Renal Transplantation

Kidney Transplantation - Adults

Interventional neuroradiology in cerebrovascular disease: Centro Hospitalar Universitário do Porto, E. P. E., in collaboration with Centro Hospitalar Universitário de São João

Congenital coagulopathies

Cochlear implants: Centro Hospitalar Universitário de Coimbra, E. P. E., in collaboration with Centro Hospitalar Universitário do Porto, E. P. E.

Familial Paramyloidosis

Pancreas Transplantation

Liver Transplantation

UMIB - Unit for Multidisciplinary Research in Biomedicine

CHUdSA Research Teams

PTCRIN

The Hospital Center is a member of the PtCRIN Consortium, an infrastructure dedicated to promoting national and international research cooperation.  This link has been key in the contact with other research centers, supporting regulatory guidelines for clinical trials and retrieving funds for investigator-initiated clinical trials. PtCRIN partners with the European Network Infrastructure (ECRIN).

Porto4Ageing

The Porto4Ageing consortium intends to aggregate and be a space for discussion of issues related to active and healthy aging in the metropolitan region of Porto. The consortium brings together more than 90 organizations from the Northern Region of Portugal and involves universities, research centers, policymakers, users, and industry.

VACCELERATE Project

VACCELERATE is a new Horizon 2020 program launched in February 2021, aiming to accelerate phase 2 & 3 clinical trials with COVID-19 vaccines. VACCELERATE brings together multiple stakeholders from Europe and countries associated with the European Union involved in vaccine development to create a single access platform for the development of such clinical trials.

CHAIMELEON Project

Accelerating the lab to market transition of AI tools for cancer management

CHAIMELEON will set up an EU-wide structured repository for health imaging data as an open source for artificial intelligence (AI) experimentation in cancer management.

Frequently Asked Questions

What is a clinical trial?

According to the legislation on research involving human subjects, a clinical trial is a research study with human subjects, which implies that when entering the trial, subjects actively participate in it. Clinical trials are designated experimental studies, because their purpose is to evaluate the effects of an intervention on the patient's health, testing the efficacy and safety of a particular drug in a given clinical condition or pathology.

Which/What are the different clinical development phases of a clinical trial?

The clinical development (process/program) of a drug in a common/given disease is as follows:

What would make me consider participating in a clinical trial?

Participating in a clinical trial means being able to participate in the development of new drugs, contributing to scientific research, and helping people affected by the same disease, not only in Portugal but throughout the world. 

Where can I find information about clinical trials in Portugal?

Clinical trial sponsors share essential information on websites available to health professionals and to the general public. You may find information on:

- National Clinical Trial Registry (RNEC): http://www.rnec.pt
- Clinical Trials: https://clinicaltrials.gov 

Which authorities evaluate whether the trial can be conducted on humans?

Clinical research in Portugal is subject to requirements stipulated by international guidelines and national legislation. This legislation publicly assures that the rights, safety, and well-being of participants are protected, and that collected data can be trusted. All parties involved are obliged to scrupulously comply with all these regulations.

In Portugal, conducting a clinical trial depends on the approval/prior evaluation by two regulatory entities: the National Authority of Medicines and Health Products (INFARMED) and the Ethics Committee for Clinical Research (CEIC).

CEIC acts under the responsibility of the Health Ministry and exercises its authority in Portugal.

INFARMED is the national authority responsible for authorizing and supervising therapeutic products, ensuring the quality, safety, and efficacy of medicines and medical devices.

Who is eligible to participate in a clinical trial?

For each trial, the study protocol and informed consent form clearly define which patients are eligible to potentially participate in the trial. The factors that allow some people to participate in a trial are called inclusion criteria, while those that do not allow a person to participate are called exclusion criteria. These criteria are based on factors such as age, gender, disease type and stage, previous treatments, other medical conditions, and values of analytical parameters. Together, inclusion and exclusion criteria define the trial population. The use of inclusion/exclusion criteria is an important principle in clinical research that helps protect the safety of participants and obtain reliable results. Therefore, before participating in a clinical trial, a person’s inclusion and exclusion criteria should be carefully assessed by the trial physician.

It should be emphasized that inclusion and exclusion criteria are not used to discriminate between participants, but rather to identify the most suitable people for that trial and protect their health, minimizing potential risks of the experimental drug. Your doctor will discuss these criteria with you to determine your eligibility.

What is the informed consent?

The decision to participate in a trial is voluntary and belongs solely to the patient, after receiving appropriate information from the physician. The investigators provide a patient information form and an informed consent that includes detailed trial information.

This information is developed for the potential participant, using accessible language, and includes the following points:

As with all trial-related materials, the informed consent form is reviewed and approved by CEIC. It is very important that you clarify any questions or concerns you may have with the trial physician or other trusted person, treating physician, family, friends, or patient organization representatives. If you agree to participate in the trial, you will have to sign the informed consent form.

At any time, the participant has the right to no longer wish to participate and leave the clinical trial by withdrawing informed consent.

What are my rights and obligations as a participant?

As with any medical procedure, the decision to participate belongs to the patient. No one can force or influence you in any way. You can always change your mind if you decide to participate. No explanation is necessary if you do not provide consent or if you withdraw it. You have the right to be informed before the trial begins, during its development, and after it ends. You can ask the attending physician questions at any time, using the contact details provided.

If you decide to participate in the trial, you will be asked to document your decision by signing the informed consent form specially developed for that specific study. In giving your consent, you are expected to follow guidelines for your safety and health. The trial team will provide support to the extent possible.

Will I be compensated for participating in a clinical trial?

Participation in clinical trials is voluntary and may not legally be financially compensated.

However, the participant will be reimbursed for expenses incurred while participating in the clinical trial. Eligible expenses include travel, meals, and lost wages.

What are the benefits and risks of participating in a clinical trial?

The benefits and risks of participating in a clinical trial are trial-specific, depending on the study design, study drug, trial population, and trial assessments. But in general terms, the major benefits of your participation in a clinical trial are:

It may be that the benefits of the experimental treatment will not be demonstrated and you derive no benefit from participating in the trial. On the other hand, there are risks or adverse effects that may not be fully known and potentially affect the participant's health.


The experimental treatment may not have the expected efficacy, and the participant may experience no positive effects or experience negative effects on his/her health. However, based on previous pre-clinical or clinical studies, the experimental treatment is expected to improve some aspects of your disease.

As a participant, you should consider not only the benefits but also the risks associated with the experimental treatment and other trial-related procedures.

As the clinical development unfolds, new information may become available. Information will be made available in due course regarding any changes in benefits and risks that may influence your decision to continue participating in the trial. It is very important to keep the research team informed of any changes in your medical condition and of new signs or symptoms. If you suffer any loss or damage as a result of the investigational product or trial-related procedures, all liabilities will be covered by the insurance contracted by the sponsor.

What kind of treatment do I receive after finishing the trial?

After clinical trial conclusion, the investigational drug must be made available free of charge by the sponsor to the participant until its introduction in the market and reimbursement by the National Health Service (SNS), provided that the investigator considers its continued use by the participant to be essential and there are no therapeutic alternatives of comparable efficacy and safety, and provided that certain rules defined in Law are complied with by the investigator.

If I am being followed at Centro Hospitalar Universitário do Porto, how can I find out more about clinical trials in my disease?

The doctor in your specialty consultation can clarify whether the medication you are taking is sufficient or whether there are new treatment prospects. Even if your disease is not controlled, there may not be other innovative medicines available, or these medicines may still be in very early development stages.