Browsing by Author "Torres, Tiago"
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- Assessment of Competencies of Clinical Research Professionals and Proposals to Improve Clinical Research in Portugal.Publication . Bogas, Mónica; Antas, Joana; Magalhães, Cátia; Revige, Mafalda; Guerra, Liliana; Ribeiro, Cheila; Eça, Rita Cunha; Nunes, Filipa; Lopes, Ana; Costa, Luís; Gonçalves, Mónica; Pedrosa, Jorge; Capela, Andreia; Gregório, Tiago; Dias, Patrícia; Alfaro, Tiago; Pais, Ana; Soares, Rui; Queirós, Ana; Torres, Tiago; Assis, Joana; Maia, Joana; Ferreira, Margarida; Horta, Luís; Carreiro, Rita; Almeida, João; Meireles, Maria João; Loução, Carla; António, Sofia; Lopes, Catarina; Coelho, Pedro; Costa, Rita; Santana, Margarida; Sousa, NunoBackground: Clinical studies are coordinated by multidisciplinary teams, which often lack adequate training and competencies. In this study, ROCHE and AICIB (Agency for Clinical Research and Biomedical Innovation) conducted a self-assessment survey aiming to evaluate the competency of clinical research professionals to conduct clinical research in Portugal and promote the identification of key actions to address priority gaps. Methods: Clinical research professionals from 10 Portuguese centres answered an electronic survey, adapted and translated from the Joint Task Force for Clinical Trial Competency (JTFCTC) framework. Representatives of the centres, ROCHE and AICIB held a meeting to discuss the survey results, identify priority gaps and propose recommendations. Results: A total of 109 participants answered the questionnaire with the following national geographical distribution: North (n = 46), Centre Region (n = 16), and Lisbon metropolitan area (n = 47). A considerable proportion were Investigators (44.0%) and had more than 10 years of experience (34.9%). The eight JTFCTC Domains scored under 60% in the level of knowledge, with Investigators achieving overall higher scores. To address these gaps, key actions were proposed, such as enhancing training and educational opportunities, fostering collaboration and networking, and investing in infrastructure and resources. Conclusion: This study was the first to assess clinical trial competency in Portugal, registering a high participation rate. The study highlights the need to develop a national plan of action, in a collaborative effort, between clinical research centres, universities, industry, regulatory authorities, national agencies, and patient organizations. This will not only contribute to elevate the quality of studies but also improve compliance with international standards, ultimately benefiting both researchers and patients.
- Dupilumab in Patients with Atopic Dermatitis: A Multicentric, Long-Term, Real-World Portuguese Study.Publication . Torres, Tiago; Cruz, Maria João; Gonçalo, Margarida; Filipe, Paulo; Duarte, Bruno; Alves, João; Alvarenga, José Miguel; Rosa, Gilberto; Flor, Duarte; Ramos, José; Sousa, Diogo; Rosca, Aureliu; Magalhães, César; Claro, Cristina; Rocha, Joana; Vilarinho, Catarina; Mota, Fernando; Mota, Alberto; Lopes, Maria João PaivaIntroduction: Several clinical trials have established the efficacy and safety of dupilumab for treating atopic dermatitis (AD). However, literature remains scarce in reporting the long-term effectiveness, safety, and drug survival of dupilumab in real-world settings. This study aimed to describe the latter outcomes of dupilumab in patients with AD. Methods: This Portuguese, multicentric, observational, retrospective study included consecutive adult patients with AD who initiated dupilumab between January 2019 and September 2023, with a follow-up period up to 30 months. Drug discontinuation and adverse effects data were used to estimate drug survival. Clinical assessments included the Eczema Area and Severity Index (EASI), pruritus numerical rating scale (NRS), and Dermatology Life Quality Index (DLQI). Results: A total of 312 patients were included in the study, with 56.4% being male (median age of 30 years, range 18-83). The 30-month drug survival rate was 82.0%. During the study period, 12.5% of the sample (n = 39 patients) discontinued treatment: 7.3% due to treatment failure, 2.9% due to safety concerns, 1.3% due to complete disease control, 0.6% due to pregnancy, and 0.3% due to lack of compliance. Adverse events not leading to drug discontinuation were noted in 25.6% of the sample (n = 80). Conjunctivitis was the most frequently reported adverse event (17%), followed by facial erythema (9%). At 30 months, the mean EASI decreased significantly from 27.30 ± 11.89 at baseline to 2.92 ± 3.96 (p < 0.001), reflecting an overall improvement of 89.3%. Similarly, pruritus NRS decreased from 7.36 ± 1.90 at baseline to 1.74 ± 2.16 at month 30 (p < 0.001), improving by 76.4%, and mean DLQI changed from 18.0 ± 7.09 at baseline to 2.67 ± 3.95 at month 30 (p < 0.001), decreasing by 85.2%. Conclusions: This study increases our current understanding of dupilumab in real-world settings, demonstrating its long-term effectiveness and safety in treating AD.