Streamlined Operational Approaches and Use of e-Technologies in Clinical Trials: Beat Acute Myeloid Leukemia Master Trial.

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.

Use of EHRs data for clinical research: Historical progress and current applications.

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.

Isotretinoin and antidepressant pharmacotherapy: a prescription sequence symmetry analysis.

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.

Economic evaluation of a 2-dose hepatitis B vaccination regimen for adolescents.

Objective: To investigate the economic implications of a 2-dose hepatitis B virus vaccination regimen compared with the current 3-dose vaccination regimen for adolescents in 3 settings: public schools, public health clinics, and private sector settings in the United States.

Methods: To measure resource utilization and costs associated with the administration of the 3-dose regimen and to assess vaccination compliance rates with this regimen, primary data were collected with the use of questionnaires tailored for each setting. Conservative modeling assumptions were used to derive 2-dose compliance rates from 3-dose compliance data.