Addressing Challenges to Enhance Clinical Research in Portugal: Insights from the OncoT3 Expert Group Delphi Study.

Introduction Over the past decades, clinical research has evolved significantly, driven by advances in regulatory frameworks, technological innovations, and methodological approaches. In Portugal, while there has been progress - such as increased regulatory alignment with European standards and the adoption of digital trial management tools - various challenges remain. These may include, among others, limited access to funding, slower patient recruitment rates, and regulatory hurdles that can delay trial approvals. Our goal was to identify key areas for improvement toward the optimization of clinical research practices in the country. Methods A modified three-round Delphi study was conducted online (2023-2024) to achieve a nationwide expert consensus. The scientific committee, composed of seven experts, developed 45 initial statements across five topics: dedication time to clinical research, organization of integrated research centers, conditions for implementing clinical trials, the role of institutional authorities, and patient recruitment and referral. A five-point Likert-type scale was used (1 - 'strongly disagree', 2 - 'disagree', 3 - 'neither agree nor disagree', 4 - 'agree', and 5 - 'strongly agree') to rate each statement. The consensus threshold was established as a percentage of agreement among participants (≥90% in the first round and ≥85% in the second round). The level of consensus achieved by the panel was discussed by the scientific committee during virtual meetings. Results Fifty-one experts completed the exercise (86.4% response rate). Consensus was reached on 32 of the 45 initial statements (71.1%) in the first round, with most of them (n = 20, or 62.5%) presenting high concordance rates (>95%). Four new statements were added for the second round, grounded on the feedback from the experts. By the end of the study, consensus was achieved on 45 out of the 49 final statements (91.8%), with the greatest agreement on the organization of integrated research centers and conditions for implementing clinical trials. Three statements regarding patient recruitment and referral, and one statement on the role of institutional authorities to promote clinical research, did not reach consensus, highlighting the need for further dialogue and innovative solutions in these fields. Conclusion The insights of this study can inform health organizations, regulatory agencies, and other stakeholders about the barriers and opportunities to improve clinical research in Portugal. By learning from global best practices and tailoring strategies to local contexts, the country can become a more prominent player in the international community.