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2.
Farm Hosp ; 44(7): 66-70, 2020 06 13.
Article in English | MEDLINE | ID: covidwho-599574

ABSTRACT

The health crisis resulting from the rapid spread of SARS-CoV-2 worlwide, added to the low evidence of currently used treatments has led to the development of a large number of clinical trials (CT) and observational studies. Likewise,  important measures have been adopted in healthcare and research centers  aimed at halting the pandemic as soon as possible. The objective of this study is  to gather the main aspects of the clinical research studies undertaken by the  Departments of Hospital Pharmacy (DHP) of Spain during the COVID-19 crisis. The decision of the Spanish Society of Hospital Pharmacy (SEFH) to sponsor CTs made it possible that 13% of DHP had been led at least one CT.  The Spanish Agency for Medicines and Medical Devices (AEMPS), in coordination  with Institutional Review Boards, has adopted a fast-track review procedure to  accelerate authorizations for CTs related to the treatment or prevention of  COVID-19. There have also been numerous public and private calls for financing  research projects aimed at contributing to the fight against this virus. Despite  the pandemic, actions have been taken to continue ongoing CTs and studies  while the safety and well-being of patients are guaranteed. More specifically, the AEMPS and the European Medicines Agency (EMA) have issued guidelines that  incorporate changes to CT protocols that will have to be applied until the  pandemic is over. In this health emergency, the scientific community has found  itself in a race against time to generate evidence. It is at this moment that  hospital pharmacists emerge as key players in clinical research and are  contributing to a rational, effective and safe healthcare decision-making.


Subject(s)
Betacoronavirus , Clinical Trials as Topic , Coronavirus Infections/drug therapy , Infection Control/organization & administration , Multicenter Studies as Topic , Observational Studies as Topic , Pandemics , Pharmacy Service, Hospital/organization & administration , Pneumonia, Viral/drug therapy , Antiviral Agents/therapeutic use , Clinical Trials as Topic/economics , Clinical Trials as Topic/statistics & numerical data , Coronavirus Infections/epidemiology , Coronavirus Infections/prevention & control , Decision Making , Drugs, Investigational/therapeutic use , Forecasting , Humans , Multicenter Studies as Topic/economics , Multicenter Studies as Topic/statistics & numerical data , Observational Studies as Topic/economics , Observational Studies as Topic/statistics & numerical data , Pandemics/prevention & control , Patient Safety , Pneumonia, Viral/epidemiology , Pneumonia, Viral/prevention & control , Research Design , Research Support as Topic , Role , Spain
3.
Farm Hosp ; 44(7): 66-70, 2020 06 13.
Article in English | MEDLINE | ID: covidwho-597842

ABSTRACT

The health crisis resulting from the rapid spread of SARS-CoV-2 worlwide, added to the low evidence of currently used treatments has led to the development of a large number of clinical trials (CT) and observational studies. Likewise,  important measures have been adopted in healthcare and research centers  aimed at halting the pandemic as soon as possible. The objective of this study is  to gather the main aspects of the clinical research studies undertaken by the  Departments of Hospital Pharmacy (DHP) of Spain during the COVID-19 crisis. The decision of the Spanish Society of Hospital Pharmacy (SEFH) to sponsor CTs made it possible that 13% of DHP had been led at least one CT.  The Spanish Agency for Medicines and Medical Devices (AEMPS), in coordination  with Institutional Review Boards, has adopted a fast-track review procedure to  accelerate authorizations for CTs related to the treatment or prevention of  COVID-19. There have also been numerous public and private calls for financing  research projects aimed at contributing to the fight against this virus. Despite  the pandemic, actions have been taken to continue ongoing CTs and studies  while the safety and well-being of patients are guaranteed. More specifically, the AEMPS and the European Medicines Agency (EMA) have issued guidelines that  incorporate changes to CT protocols that will have to be applied until the  pandemic is over. In this health emergency, the scientific community has found  itself in a race against time to generate evidence. It is at this moment that  hospital pharmacists emerge as key players in clinical research and are  contributing to a rational, effective and safe healthcare decision-making.


Subject(s)
Betacoronavirus , Clinical Trials as Topic , Coronavirus Infections/drug therapy , Infection Control/organization & administration , Multicenter Studies as Topic , Observational Studies as Topic , Pandemics , Pharmacy Service, Hospital/organization & administration , Pneumonia, Viral/drug therapy , Antiviral Agents/therapeutic use , Clinical Trials as Topic/economics , Clinical Trials as Topic/statistics & numerical data , Coronavirus Infections/epidemiology , Coronavirus Infections/prevention & control , Decision Making , Drugs, Investigational/therapeutic use , Forecasting , Humans , Multicenter Studies as Topic/economics , Multicenter Studies as Topic/statistics & numerical data , Observational Studies as Topic/economics , Observational Studies as Topic/statistics & numerical data , Pandemics/prevention & control , Patient Safety , Pneumonia, Viral/epidemiology , Pneumonia, Viral/prevention & control , Research Design , Research Support as Topic , Role , Spain
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