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5PSQ-073 Risk score for drug discrepancy and adherence in clinical trial patients
  1. E Tejedor Tejada,
  2. J Peralta Alvarez,
  3. B Gomez Perez,
  4. S Tena Mestre,
  5. S Balsells Vives,
  6. M De Riba Soler,
  7. M Boillos Fernandez,
  8. A Torrent Rodriguez,
  9. T Lizondo Lopez,
  10. D Soy Muner
  1. Hospital Clinic Barcelona, Pharmacy, Barcelona, Spain


Background and Importance The main challenge in clinical trials (CT) is to detect poor adherence to oral treatments which may influence on treatment effectiveness. Therefore, a tool is needed to help us stratify patients according to the risk of non-compliance.

Aim and Objectives To assess adherence in patients with oral experimental treatment and validate a predefined score to detect patients with poor or non-adherence.

Material and Methods An experimental, prospective, single-centre study was conducted, with mainly onco-haematologic patients, in a clinical trials unit of a tertiary hospital. A scoring was designed to detect non-adherence. Patients were stratified based on demographic information (age, native), clinical data (pathology, status) and trial characteristics (phase, protocol, complexity). All risk variables were at the same level and each received a 1-point score. Risk level of non-adherence was considered high (4–7), medium (3) and low (1–2). Patients were contacted by telephone to detect compliance discrepancies, patient concerns/questions in reference to the real adherence. The software used were SAP (clinical history), Fundanet (clinical trial platform), Excel (data collection form). The project was approved by Hospital’s Ethics Committee.

Results Thirty-five patients were recruited from 1 July to 20 September 2023. The mean age of the patients was 63.4 years. The mean non-adherence score was 2.2 (±0.92). Nine out of 35 (25.7%) of the patients were on treatment with more than one drug at the same CT and 80% were on treatment with other drugs outside the clinical trial. 75% of the patients were accompanied by another person (family or partner) when starting treatment at the pharmacy´s clinical trial unit. The CT phases with the highest recruitment were: II (29.3%) and III (27.4%). In 95% of patients no concerns on drug administration were detected, with a ‘real’ adherence rate of 92%.

Conclusion and Relevance Clinical trial patients included in this study showed good adherence to the experimental treatment. However, a larger sample size might be needed to verify these results.

References and/or Acknowledgements 1. Gillani SW, Gulam SM, Thomas D, Gebreighziabher FB, Al-Salloum J, et al. Role and Services of a Pharmacist in the Prevention of Medication Errors: A Systematic Review. Curr Drug Saf. 2021;16(3):322–328. doi: 10.2174/1574886315666201002124713. PMID: 33006539.

Conflict of Interest No conflict of interest.

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