About this Research Topic
Globally, the pursuit and dissemination of knowledge hold a place of distinction, and the public expects to gain significant benefits from the creative and innovative contributions of scientists. As science becomes increasingly intertwined with major social, philosophical, economic, and political issues, scientists must become more accountable to society. Therefore, it's more important than ever for scientists and their institutions to periodically reassess the values and professional practices guiding their research, ensuring they perform their work with integrity.
Behind every medication and treatment that people have taken and received are thousands of patients who volunteered to participate in clinical trials. Over the last few decades, this has led to many breakthroughs in disease prevention and treatment. Without the willingness of these individuals, many would have suffered. The coronavirus pandemic has made it clearer than ever how clinical trials inform healthcare decision-making and public policies. Amid the extraordinary research focus on COVID-19, over two hundred scientific articles have been retracted. Of these, six were randomized clinical trials—a high-validity study design that, according to the principles of evidence-based medicine, would have provided the most reliable evidence to inform practice. It's likely that not all retractions resulted from deliberate fraud or fabrication. Unintentional errors and technique faults probably played a part.
The value of clinical trials depends on the quality of the information produced and the relevance of the data for public health needs. However, medical training often fails to cover clinical trial integrity in its curriculum, both at undergraduate and postgraduate levels. This is partly because several countries lack a well-developed medical infrastructure and have little experience in conducting trials. Additionally, there is considerable heterogeneity in healthcare systems both across and within countries, leading to differences in how clinical trials are conducted—from the ethical review and approval process to data monitoring, patient safety, and the analysis and reporting of trial data.
Concerns about the integrity of clinical trials have led to increased demand for public documentation of all aspects of their lifecycle. Education and training in clinical trial integrity are essential moving forward. To address these challenges, this Research Topic welcomes submissions on all aspects of research integrity in clinical trials. The Topic covers the entire research lifecycle of clinical trials, including design, approvals, conduct, monitoring, analysis, and reporting. Issues of particular interest include, but are not limited to, the following:
• scientific journals' instructions for authors
• authorship of multicenter trials
• conflicts of interests
• openness of public documentation
• transparency of reporting
• data sharing
• post-publication handling of complaints
• best practice guidelines and any integrity-related matters that are relevant to the training and development of clinical trialists.
Behind every medication and treatment that people have taken and received are thousands of patients who volunteered to participate in clinical trials. Over the last few decades, this has led to many breakthroughs in disease prevention and treatment. Without the willingness of these individuals, many would have suffered. The coronavirus pandemic has made it clearer than ever how clinical trials inform healthcare decision-making and public policies. Amid the extraordinary research focus on COVID-19, over two hundred scientific articles have been retracted. Of these, six were randomized clinical trials—a high-validity study design that, according to the principles of evidence-based medicine, would have provided the most reliable evidence to inform practice. It's likely that not all retractions resulted from deliberate fraud or fabrication. Unintentional errors and technique faults probably played a part.
The value of clinical trials depends on the quality of the information produced and the relevance of the data for public health needs. However, medical training often fails to cover clinical trial integrity in its curriculum, both at undergraduate and postgraduate levels. This is partly because several countries lack a well-developed medical infrastructure and have little experience in conducting trials. Additionally, there is considerable heterogeneity in healthcare systems both across and within countries, leading to differences in how clinical trials are conducted—from the ethical review and approval process to data monitoring, patient safety, and the analysis and reporting of trial data.
Concerns about the integrity of clinical trials have led to increased demand for public documentation of all aspects of their lifecycle. Education and training in clinical trial integrity are essential moving forward. To address these challenges, this Research Topic welcomes submissions on all aspects of research integrity in clinical trials. The Topic covers the entire research lifecycle of clinical trials, including design, approvals, conduct, monitoring, analysis, and reporting. Issues of particular interest include, but are not limited to, the following:
• scientific journals' instructions for authors
• authorship of multicenter trials
• conflicts of interests
• openness of public documentation
• transparency of reporting
• data sharing
• post-publication handling of complaints
• best practice guidelines and any integrity-related matters that are relevant to the training and development of clinical trialists.
Keywords: randomised clinical trials, clinical trials, public health, medical training
Important Note: All contributions to this Research Topic must be within the scope of the section and journal to which they are submitted, as defined in their mission statements. Frontiers reserves the right to guide an out-of-scope manuscript to a more suitable section or journal at any stage of peer review.
