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

Launched by COMPLEJO HOSPITALARIO UNIVERSITARIO DE BADAJOZ · Sep 18, 2024

Keywords

ClinConnect Summary

The "MedeA" trial is a study designed to explore how personalized medicine and pharmacogenetics (the study of how genes affect a person's response to drugs) can help reduce adverse drug events, which are harmful effects caused by medications. This trial will focus on adults who are being treated with certain medications known to have significant side effects. Researchers will provide participants with important information about their medications, including how their genes might influence their reactions to these drugs, but no new treatments will be given.

To participate, you must be at least 18 years old and currently receiving treatment that meets the study's criteria. If you're under 18, there are specific rules about parental consent. Participants should also be registered with the Extremadura Health Service and able to communicate effectively. If you join the study, you can expect regular follow-ups where you'll receive guidance about your medications, helping to ensure your safety and well-being while being treated.

Gender

ALL

Eligibility criteria

• 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 following assumptions:
• • If the minor is under 12 years of age, participation will require the consent and signature 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 will be provided and signed by both parents (if both parents are present at the time of the interview) or only one of them (in which case one of the following two conditions must be stated: that the other parent is not present at the time of the interview but does not object to the participation of the minor in the study or that the 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 totally dependent on another person.
• 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 part of the cohort during follow-up.
• • Manifest difficulty for follow-up.