Publications by authors named "E Alger"
Article Synopsis
- Early phase clinical trials focus on evaluating the safety and tolerability of new therapies, primarily using investigator and lab results rather than patient feedback.
- A recent expert roundtable brought together 22 stakeholders to discuss the need for a universal patient-reported outcomes (PRO) model in early phase trials and how to effectively incorporate PROs to assess tolerability and guide treatment decisions.
- The discussions yielded key recommendations and identified priority areas for further research on integrating patient feedback into early trials to improve safety and symptom management.
Fertilization is a fundamental process that triggers seed and fruit development, but the molecular mechanisms underlying fertilization-induced seed development are poorly understood. Previous research has established AGamous-Like62 (AGL62) activation and auxin biosynthesis in the endosperm as key events following fertilization in Arabidopsis (Arabidopsis thaliana) and wild strawberry (Fragaria vesca). To test the hypothesis that epigenetic mechanisms are critical in mediating the effect of fertilization on the activation of AGL62 and auxin biosynthesis in the endosperm, we first identified and analyzed imprinted genes from the endosperm of wild strawberries.
View Article and Find Full Text PDFBackground: Determining the maximum tolerated dose (MTD) remains the primary objective for the majority of dose-finding oncology trials. Whilst MTD determination often relies upon clinicians to identify dose-limiting toxicities (DLTs) experienced by patients during the trial, research suggests that clinicians may underreport patient's adverse events. Therefore, contemporary practice may be exposed to recommending intolerable doses to patients for further investigation in subsequent trials.
View Article and Find Full Text PDFArticle Synopsis
- The FDA's Project Optimus is encouraging the use of Patient-reported Outcome (PRO) data to better assess how tolerable new cancer therapies are in early clinical trials, moving beyond just clinician evaluations of side effects.
- A virtual session engaged various experts and patient advocates to discuss how to effectively incorporate PROs in trial designs, highlighting the value of patient input in this process.
- While there is support for using PROs, participants expressed concerns that it might lead to lower recommended doses and hesitation among patients to accurately report symptom severity.
Dose-finding oncology trials (DFOTs) provide early access to novel compounds of potential therapeutic benefit in addition to providing critical safety and dosing information. While access to trials for which a patient is eligible remains the largest barrier to enrollment on clinical trials, additional direct and indirect barriers unique to enrollment on DFOTs are often overlooked but worthy of consideration. Direct barriers including financial costs of care, travel and time investments, and logical challenges including correlative study designs are important to bear in mind when developing strategies to facilitate the patient experience on DFOTs.
View Article and Find Full Text PDF