Background <p>Clinical 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.</p> Methods <p>We 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).</p> Results <p>Awareness 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).</p> Conclusions <p>Awareness 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.</p>

错误:搜索内容不能为空,请输入英文关键词
错误:关键词超出字数限制,请精简
高级检索

Ethical and Regulatory Awareness of Clinical Trials: A Nationwide Cross-Sectional Study from Poland

  • Damian Swieczkowski,
  • Jacek Burzyński,
  • Aleksander Kwaśny,
  • Michal Pruc,
  • Lukasz Szarpak,
  • Wiesław Jerzy Cubała

摘要

Background

Clinical 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.

Methods

We 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).

Results

Awareness 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).

Conclusions

Awareness 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.