About this Research Topic
Globally, the pursuit and dissemination of knowledge enjoys a place of distinction, and the public expects to reap considerable benefit from the creative and innovative contributions of scientists. As science becomes increasingly tangled with major social, philosophical, economic, and political issues, scientists become more accountable to the wider society. Therefore, it is more important than ever that scientists and their institutions periodically reassess the values and professional practices that guide their research to perform their work with integrity.
Behind every medication and treatment that people have ever taken and received there are thousands of patients who have 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 itself has made it clearer than ever how clinical trials inform healthcare decision-making and public policies. In the midst of the extraordinary research focus on COVID-19 over the last few years, over two hundred scientific articles have been retracted. Of these, six have been randomized clinical trials; a high-validity study design which, according to the rules of evidence-based medicine, would have provided the most reliable evidence to inform practice. It is likely that not all retractions are the result of deliberate fraud and fabrication. Unintentional errors and faults in technique are bound to have played their part.
The value of clinical trials hinges on the quality of information produced as well as the relevance of the data for public health needs. Nevertheless, medical training generally fails to cover clinical trial integrity in its curriculum, often both at undergraduate and at postgraduate levels. This is partly due to the fact that several countries lack a well-prepared medical infrastructure and have little to no experience in conducting trials. Moreover, when it comes to health care systems, there is considerable heterogeneity both across and within countries. This may result in differences in how clinical trials are conducted, from the ethical review and approval process itself, to data monitoring and patient safety, and to the analysis and reporting of trial data.
Concerns around the integrity of clinical trials have resulted in greater demand for the public documentation of all aspects of their lifecycle. Education and training in clinical trial integrity is thus an essential requirement going 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 ever taken and received there are thousands of patients who have 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 itself has made it clearer than ever how clinical trials inform healthcare decision-making and public policies. In the midst of the extraordinary research focus on COVID-19 over the last few years, over two hundred scientific articles have been retracted. Of these, six have been randomized clinical trials; a high-validity study design which, according to the rules of evidence-based medicine, would have provided the most reliable evidence to inform practice. It is likely that not all retractions are the result of deliberate fraud and fabrication. Unintentional errors and faults in technique are bound to have played their part.
The value of clinical trials hinges on the quality of information produced as well as the relevance of the data for public health needs. Nevertheless, medical training generally fails to cover clinical trial integrity in its curriculum, often both at undergraduate and at postgraduate levels. This is partly due to the fact that several countries lack a well-prepared medical infrastructure and have little to no experience in conducting trials. Moreover, when it comes to health care systems, there is considerable heterogeneity both across and within countries. This may result in differences in how clinical trials are conducted, from the ethical review and approval process itself, to data monitoring and patient safety, and to the analysis and reporting of trial data.
Concerns around the integrity of clinical trials have resulted in greater demand for the public documentation of all aspects of their lifecycle. Education and training in clinical trial integrity is thus an essential requirement going 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.
