TECHNOLOGICAL DEMAND 5:
Tools for clinical evaluation and adverse reactions.-"Use of biosensors and other procedures to perform the evaluation of efficacy and adverse reactions in real life".

Summary table of the technological challenge 5

Subproject/Technological ChallengeInnovation SectorProducts and tasks
5. Clinical effect and adverse drug reactions tools Evaluation of clinical effect and ADRBiosensing companies;
e-Health
5a). Application to a group of patients among those studied in the pilot 5a). Development of tools and/or devices (i.e. biosensors) for the evaluation of clinical response and adverse reactions in cardiovascular and metabolic, mental and oncological diseases, pain.
5b) Database of markers in the clinical response and Adverse Reactions (potential algoritm) (1f)

For more information: https://www.boe.es/diario_boe/txt.php?id=BOE-A-2018-8151 *JARA Historia Clinica Electrónica, Servicio Extremeño de Salud (SES)

Current situation:

Most of the information obtained from the patient comes from the questioning during the clinical interview, or from analytical data from the laboratory. However, the situation and the impact on the patient’s daily life of applied therapeutic is largely unknown. In many cases there is a discrepancy between the variables selected by the design of an investigation with respect to those really relevant for patients. It is therefore increasingly important to have an evaluation of the clinical impact that a specific therapeutic has on daily life, in such a way that the clinician can have real-time access to parameters that can be decisive for decision making, for example the daily intake of glucose, the blood pressure in patients with cardiovascular and metabolic pathology, or the movement in patients with mental pathology, sleeping habits, nourishment, etc.

Objective:

Development of tools for evaluation of response and adverse reactions in real life. The interconnectivity of the devices will be sought in order to link them with the electronic medical record, for example, analytical controls on anticoagulants, glucose, blood pressure, etc.
The possibility of extending them to Latin American populations will be valued. Application of the methodology developed in a pilot study, which may be extended to 3,000 patients of whom genetic and analytical information is available.

Functionality required by the suggested solutions:

Ability to evaluate at the patient’s home in routine conditions determining parameters for the evaluation of the impact of a therapy, biomarkers, lifestyle (nourishment, etc.), physiological habits (sleep, intestinal function), etc.
Main ability to detect the most frequent and/or important adverse reactions, and evaluation of efficacy in the treatment of cardiovascular and metabolic diseases, treatment of cancer and pain, and mental illnesses. Ability to establish relationships between biomarkers and adverse reactions that could be integrated into a database.

Summary of products and tasks (Table):

5a). Study and clinical evaluation of a group of patients among those studied in the pilot.
5b). Development of tools and/or devices (biosensors, etc.) for the evaluation of adverse reactions to drugs, and response in the pharmacological treatment of cardiovascular and metabolic, mental, oncological diseases, pain.
5c) Database of markers in the clinical response and Adverse Reactions (Relationship Algorithm) (1f).

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