ABSTRACT
Advances in genomic technologies and an increased understanding of the molecular pathogenesis of cancer have resulted in development of new effective, mutation-targeted therapies. In turn, these informed the development of Master Trial designs to test these therapies. The Beat Acute Myeloid Leukemia (BAML) Master Trial (Sponsor: The Leukemia & Lymphoma Society) tests several targeted therapies in patients aged ≥ 60 years with AML based on genomic profiling obtained within 7 days of study enrollment. We hypothesized that integrating operational strategies with new electronic technologies (e-technologies) might streamline the conduct and management of this Master Trial. BAML's 5 core operational strategies revolve around the guiding principle of "patients first." The e-technology platforms employed in BAML include: Clinical Oversight Platform: a central collaborative tool; e-Protocol/e-Source Upload/Electronic Data Capture Platform: digitizes the protocol, allows remote data monitoring, and collects/exports data in Study Data Tabulation Model format; and Data Review Platform: ingests data from different sources for clinical response and safety data reviews. The operational approaches, e-technologies and sponsor/contract research organization's (CRO) expertise together allow: the complexity and size of the BAML Master Trial to be better managed; near real-time study data oversight; better collaboration, communication and training; improved data collection, enhanced transmission and accessibility; data integration, review and generation of reports; while maintaining data privacy, and compliance. Initial e-technology challenges were overcome through training, learning, discipline and adjustment. In conclusion, to successfully manage Master Trials, significant time should be spent re-evaluating, improving and developing new operational approaches.Clinical Trial Registration: Clinical Trials.gov Identifier: NCT03013998. https://clinicaltrials.gov/ct2/show/NCT03013998 .
Subject(s)
Leukemia, Myeloid, Acute , Clinical Trials as Topic , Humans , Leukemia, Myeloid, Acute/drug therapy , TechnologyABSTRACT
The benefits of reusing EHR data for clinical research studies are numerous. They portend the opportunity to bring new therapies to patients sooner, potentially at a lower cost, and to accelerate learning health cycles-through faster data acquisition in clinical research studies. Metrics have proven that time can be saved, workflow and processes streamlined, and data quality increased significantly. Pilot projects and now actual investigational trials used for regulatory submissions have shown that these benefits support the transformation of clinical research by leveraging EHRs for research. Panelists at a recent collaborative focused on bridging clinical research and clinical care offered varying perspectives on how the latest standards and technologies could be leveraged to facilitate data transfer from EHR systems into clinical research databases, as well as the associated improvements in data quality. Panelists also discussed other avenues to leverage EHR in clinical research. Improvements and exciting possibilities notwithstanding, much work remains. Data ownership and access, attention to metadata and structured data for data sharing, and broader adoption of global standards are key areas for collaboration. With the steady increase in adoption of EHRs around the world, this is an excellent time for all stakeholders to work together and create an environment such that EHRs can be used more readily for research. The capacity for research can thus be increased to provide more high-quality information that will contribute to rapid continuous learning health systems from which all patients can benefit.
ABSTRACT
BACKGROUND: Isotretinoin is indicated for the treatment of severe, recalcitrant nodular acne. Spontaneous reports have suggested a possible association between isotretinoin and depression that has not been supported by prior studies. Depression has been reported in patients with acne and is common among adolescents. OBJECTIVE: The objective of this study was to investigate whether there is an association between isotretinoin use and onset of depression. METHODS: A large retrospective database study was performed through a review of pharmacy claims to evaluate the order of first-recorded isotretinoin and antidepressant dispensings in incident users. The study included 2821 patients, aged 12 to 49 years, who filled isotretinoin prescriptions between June 1, 1999, and March 31, 2000. The ratio of the number of patients who filled isotretinoin prescription first versus second was computed, with adjustment for variations in physician prescribing patterns; a ratio significantly greater than 1.0 indicates a depression-invoking relationship. Similar analyses of minocycline were performed. RESULTS: Adjusted ratios for all antidepressants and by class were not significantly greater than 1.0. Similar results were found for minocycline. CONCLUSION: The results do not support an association between the use of isotretinoin and the onset of depression.
