Purpose
The purpose of this initiative, launched by the Carlos III Health Institute (ISCIII), is to promote independent clinical research involving drugs for human use and/or advanced therapies by funding projects not sponsored by the pharmaceutical industry.
Projects of proven quality aimed at conducting clinical trials with drugs for human use and/or advanced therapies (defined as gene therapy, cell therapy, or tissue engineering) that lead to tangible improvements for patients and provide evidence to health authorities for their implementation in the National Health System (SNS). Active pharmaceutical ingredients that are currently under protection (patent or data protection) and have a single marketing authorization holder are expressly excluded.
Project content must relate to the following priority thematic areas:
- Clinical research involving advanced therapies, where the patent—if any—is majority-owned by an entity within the National Health System, including cell therapy, gene therapy, and tissue engineering.
- Clinical research on orphan drugs.
- Clinical research and studies on the therapeutic or diagnostic repurposing of drugs.
- Clinical research aimed at reducing antibiotic resistance.
- Clinical research with drugs in special populations, particularly in the pediatric population or populations that are underrepresented in commercial clinical trials.
- Clinical research on approved drugs under real-world conditions, including pharmacoepidemiological and clinical safety studies.
- Clinical research and comparative studies of medications in the context of control strategies, with an impact on public health for the National Health System (SNS).
- Clinical trials, including pharmacogenetic studies, aimed at identifying populations with varying degrees of response—in terms of efficacy and/or safety—to drugs of clinical and therapeutic relevance in healthcare practice.
The projects submitted must be clinical trials in the field of independent clinical research, preferably in phases I, II, or III; however, other types of clinical trials may also be funded, including those that require completion of the final phases of the preclinical stage prior to the start of the clinical trial, if adequately justified.
In general, research projects may be submitted under one of the following categories:
- Individual projects: Submitted by an applicant institution and to be carried out at a single site by a research team led by one or two principal investigators (PI and Co-PI) who are civil servants, statutory employees, or staff members of the applicant institution.
- Multicenter projects: Conducted in accordance with a single protocol at more than one site. Each project will have a team and will be led by one or two principal investigators (PI and co-PI). For this type of project, applicants may choose one of the following options:
- Multicenter study design with a single grant recipient institution. Submission of a single application by the institution to which the principal investigator(s) (PI and co-PI, if applicable) are affiliated, who act as project coordinators, with all collaborating researchers listed as part of the same team, regardless of the institution from which they participate.
- Multicenter study design involving several grant-receiving centers. Each participating center must submit an application, with one or two principal investigators (PI and co-PI, as applicable) and a research team for each application submitted. One of the projects will also serve as the coordinator, and its PI or, where applicable, its two PIs, will be responsible for the scientific coordination and oversight of the project as a whole.
Special consideration will be given to projects led by two principal investigators who indicate in their application report their intention to initiate a leadership transition process between the two, with one being a senior researcher and the other a young researcher. In these projects, the co-PI will be the senior researcher, while the PI will be the person to whom the transition is being made; both CVs will be given equal weight during the evaluation.
Clinical trials requested through the CIBER will only be eligible for the multicenter project category if they have a single beneficiary center and must include researchers from at least two CIBER thematic areas.
Requirements
Requirements for applicants:
The following may be eligible for this program:
- Health research institutes accredited by ministerial order (IIS).
- Public health entities and institutions with clinical assistance activities.
- Public health entities and institutions without a health activity license, but with demonstrable R+D+I activity in the area of knowledge of Public Health.
- Private healthcare entities and institutions that are licensed to provide healthcare services and are affiliated with or have agreements with the National Health System (SNS).
- The OPIs (Public Research Organizations).
- Public universities and private universities with proven R&D capacity and activity.
- State-level technology centers and state-level centers for supporting technological innovation that are registered in the Registry of Centers established by Royal Decree 2093/2008
- Other public R&D, research and knowledge dissemination centers and research infrastructures, with their own legal personality, linked to or dependent on the General State Administration or the rest of the Public Administrations and their agencies.
- Public and private non-profit entities that carry out and/or manage R&D activities, generate scientific or technological knowledge or facilitate its application and transfer.
- Public consortia and state public consortia with R&D&I activities in Biomedicine or Health Sciences and Technologies.
- Other units of the health administration
In the projects submitted, the role of sponsor must rest exclusively and solely with the managing entity of the applicant institution; projects or clinical trials in which the sponsor is a researcher are expressly excluded, regardless of whether the researcher holds this position individually or even as a co-sponsor with the applicant center.
PI requirements:
- Have a formal civil service, statutory, or employment relationship with the applying institution or the institution where the project will be carried out. The research institution must engage in clinical and patient care activities or have demonstrable capacity so that, in the absence of the former, there are no limitations on the project’s implementation. Special consideration will be given to projects led or co-led by researchers engaged in clinical and patient care activities who were born in 1981 or later.
- Not currently enrolled in a Specialized Health Training (FSE) program, not under a pre-doctoral training contract, and not employed as part of a research project.
- Not be the principal investigator of a project that has received funding through the grant calls for Independent Clinical Research Projects in 2023, 2024, or 2025.
- All members of the research team must have a formal civil service, statutory, employment, or paid training relationship with any of the entities eligible to submit applications for this initiative for at least the entire period between the deadline for submitting applications and the final decision on the award.
- Participation in the projects covered by this initiative will be compatible with submitting applications and participating in other PEICTI calls for proposals.
- No researcher acting as the sponsor of the clinical trial that is the subject of this action may apply for this call for proposals; the role of co-sponsor is expressly excluded.
- Researchers participating in this initiative may not be listed on more than one application.
Application
Applications and all other required documentation must be submitted exclusively through the ISCIII’s online portal.
Applications must be accompanied by the following documentation:
- Application Form. A single application must be submitted for each project proposed. For multicenter projects with multiple beneficiary centers, a complete application must be submitted for each of the
subprojects. - Research project report using exclusively the standardized form corresponding to AES 2026, completed in English or Spanish. For multicenter projects with multiple participating centers, a complete application must be submitted for each subproject.
- Abbreviated Curriculum Vitae (CVA), automatically generated by the FECYT’s CVN editor for the principal investigator or principal investigators in applicable projects (applications with a principal investigator and co-principal investigators). Once completed—in either Spanish or English—it must be attached to the application via the online system.
- Research track record of the research teams, completed in English or Spanish.
- All clinical and healthcare centers participating in the project that is the subject of this application and that are not directly publicly owned must submit a commitment signed by their legal representative, which must include an obligation not to bill participating patients for any type of service, including emergency care, unscheduled or unforeseen care, regardless of the nature of such care, as well as a commitment to inform participating patients of this requirement. There must be an explicit reference to this commitment in the patient information sheet.
- A commitment issued by the applicant organization and signed by its legal representative, in which the organization assumes the unequivocal obligation to act as the sole sponsor of the clinical trial should the grant that is the subject of this action be awarded.
- In multicenter projects involving multiple participating centers, the standard-format coordination report must also be completed.
Call for Applications Guidelines
The complete terms and conditions of the call for applications can be viewed by clicking here.