ArticleTherapeutic innovation & regulatory science2026
Ethical and Regulatory Awareness of Clinical Trials: A Nationwide Cross-Sectional Study from Poland.
Article in Therapeutic innovation & regulatory science, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.
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Authors and funding
6 authors.
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Abstract
backgroundClinical trials are conducted under rigorous ethical and regulatory frameworks to protect participants, including ethics committee approval, informed consent, oversight, and personal data protection. However, public awareness of these safeguards in Poland remains insufficiently studied.
methodsWe conducted a nationwide cross-sectional survey via computer-assisted web interviews with 1200 adults in Poland (January 2023). Awareness was defined as agreement with statements reflecting ethical and regulatory safeguards; "high awareness" indicated endorsement of at least 7 out of 9 items. A questionnaire covered nine core principles of clinical trials, including ethical review, informed consent, participant rights, and data protection. Descriptive statistics, chi-square tests, and logistic regression identified factors associated with high awareness (≥ 7/9 endorsed items).
resultsAwareness was generally high: 88.1% recognised the need for trials to introduce new drugs and 83.7% knew that informed consent was required. However, gaps in knowledge regarding regulatory oversight and data protection were identified. In the final multivariable logistic regression model, lower education was associated with reduced odds of high awareness (secondary vs. higher: aOR = 0.56; post-secondary vs. higher: aOR = 0.54), as was uncertainty about prior clinical trial participation ("do not know" vs. no: aOR = 0.55). Model discrimination was limited (AUC = 0.59).
conclusionsAwareness of core ethical safeguards, such as informed consent, was high, but gaps remained in regulatory oversight and data protection. Education was the strongest correlate, indicating a need for targeted communication.
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.