Precision medicine has the potential to transform drug therapy and patients’ lives. A recent study published in Human Genomics brings us closer to unlocking that potential. Here, the authors discuss how DNA sequencing and can be integrated with novel computational variant assessment methods to improve predictions of drug metabolism and response of individual patients.
Monthly Archives: May 2018
Published today in Research Involvement and Engagement a new systematic review finds that less than 1% of published clinical trials contained critical information on patients engaged in the research. Here, the authors explore the possible reasons behind this lack of reporting and how it can be improved.
Evaluating the evidence used by the US Food and Drug Administration during the drug approval process
Over the past few years, the US Food and Drug Administration (FDA) has faced continual pressure to accelerate the review and approval of new drugs, in order to promote innovation and provide rapid access to new treatments for patients with serious life-threatening conditions. As expedited review and approval programs have increasingly been adopted for certain drugs, there have been concerns that certain drugs are being approved on the basis of smaller, shorter, and fewer trials. Our study published recently in BMC Medicine aimed to evaluate one component of clinical trial evidence that informs FDA approval decisions for new drugs: the study outcomes.
In celebration of Clinical Trials Day we’re challenging you with a quiz on recent initiatives to improve trial conduct and reporting, and ultimately reduce waste in research. Take the quiz, share your results and explore what’s underway to maximise the benefits of clinical research.
Interested in what else we are doing to celebrate Clinical Trials Day? Don’t forget to visit our dedicated page.
To celebrate Clinical Trials Day 2018 and as the leaders in the field gather for the Society for Clinical Trials 2018 Conference, Lucy Chubbock, Assistant Editor for ISRCTN and Trials, considers the role of trial registries in the ever-changing landscape of clinical trials.