Evaluation of the Implementation of the Pharmacogenetics and Personalized Medicine Program "MedeA" in the Extremadura Health Service.

Last updated: September 18, 2024
Sponsor: Complejo Hospitalario Universitario de Badajoz
Overall Status: Active - Recruiting

Phase

N/A

Condition

N/A

Treatment

N/A

Clinical Study ID

NCT06607445
MedeA21.01
  • All Genders
  • Accepts Healthy Volunteers

Study Summary

An open longitudinal observational study, non-randomized, which will include the adult population, attended by the SES, in which preference will be given to those patients under treatment with drugs that can produce relevant adverse effects. It is a naturalistic study in which no pharmacological or other type of intervention will be carried out, only the information recommended in the drug data sheet (pharmacogenetic biomarkers, relevant interactions and clinical contraindications) will be provided.

Eligibility Criteria

Inclusion

Inclusion Criteria:

Patients with a recent diagnosis and who are to be or are being treated according to usual clinical practice, who meet the criteria to participate in the study, read the corresponding information sheet, sign informed consent and agree to participate, provided they meet the following inclusion criteria:

General criteria for all patients:

  • Age ≥ 18 years. In case of minors, they may be included, under the followingassumptions:

  • If the minor is under 12 years of age, participation will require the consent andsignature of the informed consent document by both parents (or their guardian).

  • If the minor is between 12 and 16 years of age, a proxy informed consent form willbe provided and signed by both parents (if both parents are present at the time ofthe interview) or only one of them (in which case one of the following twoconditions must be stated: that the other parent is not present at the time of theinterview but does not object to the participation of the minor in the study or thatthe signatory is the sole legal guardian of the minor).

  • Be registered or potentially/have been attended in the Extremadura Health Service.

  • Not have language or communication barrier or present disability being totallydependent on another person.

Exclusion

Exclusion Criteria:

  • Failure to meet any of the inclusion criteria described above.

  • Refusal by the patient to be part of the cohort initially, or to continue to be partof the cohort during follow-up.

  • Manifest difficulty for follow-up.

Study Design

Total Participants: 6445
Study Start date:
May 26, 2021
Estimated Completion Date:
December 31, 2024

Connect with a study center

  • Complejo Hospitalario Universitario de Badajoz

    Badajoz, 06080
    Spain

    Active - Recruiting

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