Evaluating a personalized medicine program in the Extremadura Health Service
Evaluation of the Implementation of the Pharmacogenetics and Personalized Medicine Program "MedeA" in the Extremadura Health Service. Population Cohort [MedeA21].
This study is testing a personalized medicine program to see if it can help adults taking certain medications avoid harmful side effects and improve their treatment results.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 6445 (estimated) |
| Sex | All |
| Sponsor | Complejo Hospitalario Universitario de Badajoz Academic / other |
| Locations | 1 site (Badajoz) |
| Trial ID | NCT06607445 on ClinicalTrials.gov |
What this trial studies
This observational study aims to assess the implementation of the MedeA pharmacogenetics and personalized medicine program within the Extremadura Health Service. It will focus on adult patients who are being treated with medications known to cause significant adverse drug events. The study will collect data without any pharmacological interventions, relying instead on providing information about pharmacogenetic biomarkers and relevant drug interactions. Participants will be monitored over time to evaluate the program's effectiveness in improving patient safety and treatment outcomes.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older who are currently receiving treatment with drugs that have known adverse effects.
Not a fit: Patients who are not currently on medications that pose a risk for adverse drug events may not benefit from this study.
Why it matters
Potential benefit: If successful, this program could enhance patient safety by reducing adverse drug events through personalized medication management.
How similar studies have performed: While similar pharmacogenetic programs have shown promise in improving patient outcomes, this specific implementation in the Extremadura Health Service is novel.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Badajoz
- Complejo Hospitalario Universitario de Badajoz — Badajoz, Spain (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.