Clinical research and clinical trials unit
The main tasks of the Clinical Research and Clinical Trials Unit (for further details see the Offering of Services):
- Collaborate with any Institute researcher who requests assistance in executing research projects either in independent fashion or as a non-profit sponsor. For this purpose, we provide scientific, methodological, ethical, legal, clinical (medical and nursing), and logistical support based on the researcher's identified needs and the resources available within each project.
- Support for-profit research, primarily for clinical trials but also for studies with other design methods. These efforts aim to expedite and facilitate the execution of these studies within our institution and increase the quality of research results in the shortest amount of time possible.
The IIS-FJD Clinical Research and Clinical Trials Unit belongs to the Spanish Clinical Research Network (SCReN). The unit is funded by the Carlos III Health Institute (Strategic Initiatives in Health, 2013-2016), the Nationwide Program for Research for Societal Challenges (under the Nationwide Plan for Scientific and Technological Research and Innovation, 2013-2016). It is a network-based structure that fosters appropriate needs assessment, management of new challenges, proposals for improvements in health strategies, and more optimal use of health-related resources in order to advance science, improve patient health, and better the health system.
Some of the primary goals of the Platform include:
- Identifying and assigning priorities to patients' health needs.
- Producing quality clinical research that may be transferred to clinical practice and contribute to care development and innovation.
- Insure that clinical research upholds ethical and legal requirements; for this purpose, common, cross-cutting tools and services are put in place so that research projects can be carried out safely, effectively, and efficiently.
- Perform excellent clinical research in terms of project design and methods and also when executing projects and broadcasting results.
- Further the training of medical staff in the methdological, ethical, and legal aspects of clinical research.
Dr. Carmen Ayuso García
Ms. Raquel Muñoz Siscart
915504800 Ext 3214
Dr. Lucía Llanos Jiménez
915504800 Ext 3144
- Iris Moreno Viera
915504800 Ext 2431
- Laura Casas Guevara
915504800 Ext 2731
The Clinical Research and Clinical Trials Unit collaborates in the following stages of research projects based on their stage of development and the assistance requested.
- Scientific and methodological support (in partnership with the Epidemiology and Statistics Unit):
- Conception of the study, drafting a project proposal that will be used in order to define the following:
- Background, hypothesis, and objectives
- Study design
- Population to be studied: inclusion and exclusion criteria, sample-size calculation
- Randomization tables
- Study course
- Plan for statistical analysis
- Statistical analysis
- Interpretation and presentation of results (tables, graphs, etc.)
- Information on statistical tools
- Support in managing the study:
- Writing the protocol and appendices
- Advisory on ethical and legal requirements and study documentation
- Assessment of financial aspects
- Taking out an insurance policy
- Launch: presentation before the Ethics Committee and the Spanish Agency of Medicines and Medical Devices
- Support in patient recruitment
- Monitoring the study
- Quality control
- Drafting of the final report
- Advisory on compliance with clinical best practices
- Procedures involving nursing: vital signs, ECG, other procedures required based on the needs of the study, blood-sample extraction, processing, storage and shipping of biological samples
- Notification in case of adverse reactions