Evolution of Hematology Clinical Trial Adverse Event Reporting to Improve Care Delivery.
Tamara P MillerRichard AplencPublished in: Current hematologic malignancy reports (2021)
Currently, adverse events are reported manually on most hematology clinical trials. Especially on phase III trials, the highest grade of each adverse event during a reporting period is typically reported. Despite the effort committed to AE reporting, studies have identified underreporting of adverse events on hematologic malignancy clinical trials, which raises concern about the true understanding of safety of treatment that clinicians have in order to guide patients about what to expect during therapy. In order to address these concerns, recent studies have piloted alternative methods for identification of adverse events. These methods include automated extraction of adverse event data from the electronic health record, implementation of trigger or alert tools into the medical record, and analytic tools to evaluate duration of adverse events rather than only the highest adverse event grade. Adverse event reporting is a crucial component of clinical trials. Novel tools for identifying and reporting adverse events provide opportunities for honing and refining methods of toxicity capture and improving understanding of toxicities patients experience while enrolled on clinical trials.
Keyphrases
- clinical trial
- adverse drug
- phase iii
- electronic health record
- phase ii
- end stage renal disease
- open label
- healthcare
- newly diagnosed
- chronic kidney disease
- palliative care
- double blind
- prognostic factors
- peritoneal dialysis
- primary care
- oxidative stress
- patient reported outcomes
- clinical decision support
- machine learning
- artificial intelligence
- bone marrow
- study protocol
- quality improvement
- cell therapy
- replacement therapy
- chronic pain
- pain management
- health insurance
- affordable care act