Approved the call for independent clinical trials of the Carlos III Health Institute
Source: www.actasanitaria.com
The Council of Ministers has authorized, on Tuesday, July 7, the Carlos III Health Institute (ISCIII), the call for grants for independent clinical research projects for the year 2020, within the Strategic Action on Health 2017- 2020.
The objective of this call is to answer relevant clinical questions for patients, their families and Spanish researchers by investing in clinical research with non-commercial drugs and advanced therapies.
This year’s call receives funding of 18.9 million euros. With this budget, the ISCIII indicates that it shows, “once again, its involvement with independent clinical research aimed at protecting people’s health through applied, useful and excellent science.” The calls promoted in this area by the ISCIII in the last two years have exceeded the sum of all those made in the last 15 years.
Among the novelties of this year, in addition to increased funding, the possibility of including preclinical studies aimed at meeting the regulatory requirements necessary to carry out clinical trials with drugs in an early stage of development stands out; the expansion of the beneficiary centers, and the possibility of presenting a greater number of proposals from the beneficiary entities.
Contents of the projects
The contents of the projects to be financed must cover areas such as clinical research with advanced therapy treatments (cell therapy, gene therapy and tissue engineering), whose patent, if it exists, belongs mainly to an entity of the National Health System ( SNS); clinical research with orphan drugs or drugs of high health interest without commercial interest; and therapeutic repositioning or diagnostic studies (research of drugs already approved for other uses).
The accredited Health Research Institutes (IIS), 31 centers located in Spanish hospitals in 12 autonomous communities in which more than 160 health and scientific institutions participate may be beneficiaries of this call; and public health entities and institutions with or without clinical healthcare activities, such as hospitals, primary care centers, other healthcare centers and units of the health administration.
Also, in this block are the private non-profit health institutions linked or agreed to the SNS; and the Center for Biomedical Research Network (CIBER), which divides its work into 11 CIBER thematic areas with almost 6,000 researchers integrated into more than 400 research groups. In this way, the range of beneficiary centers is expanded, since last year the call was only for the IIS.
The projects submitted must develop clinical trials in the field of independent clinical research, preferably in Phase I, II and III, although other types of studies may also be financed, including those that require completing the final phases of the preclinical stage in order to the start of the clinical trial. The maximum number of applications will be three for each IIS, and for the CIBER, and one in the rest of the cases. In addition, projects must have a maximum duration of four years, which is the term of execution of this call.
Latest data from the Covid-19
The Ministry of Health has published the data of the evolution of the Covid-19 in Spain corresponding to this Tuesday, July 7 , according to which a total of 252,130 confirmed cases are registered, with 124 new ones in the last day, and 28,392 deaths. , with nine in the last seven days and four new compared to the previous day. Given that 78 new positives were registered the day before, an increase is observed in this regard. The Health Administration of the Executive indicates that “an individualized validation of the cases is being carried out, so there may be discrepancies regarding the notification of previous days.”
At Distefar we welcome this news with great hope for our sector and we hope we can be of great help in the fight against this pandemic.
