Article Synopsis
- Go/No-Go decision making in early phase clinical trials for Alzheimer's is complicated due to recent negative results related to efficacy and safety issues.
- Cognitive data could play a crucial role in informing these decisions and should be analyzed at different stages of drug development.
- The review highlights the need for well-defined decision-making criteria that take into account various contexts, including development stage, mechanism of action, and trial design.
Video Abstracts
Category Ranking
98%
Total Visits
921
Avg Visit Duration
2 minutes
Citations
20
Article Abstract
Go/No-Go decision making in early phase clinical trials is challenging for drug developers working in Alzheimer's disease. Recent negative trial results have been attributed to a lack of efficacy and important safety concerns. Furthermore, demonstrated target engagement has rarely translated into demonstrable clinical efficacy. Cognitive data might provide valuable insights at various points during drug development, and a thoughtful and robust set of decision-making criteria, specified a priori, can and should be applied under many circumstances. This review provides insights into how to utilize cognitive data for Go/No-Go decisions, with an emphasis on how these cognitive criteria differ depending on the context (e.g., stage of development, mechanism of action and trial design).
Download full-text PDF |
Source |
|---|---|
| http://dx.doi.org/10.1016/j.drudis.2021.01.012 | DOI Listing |
Publication Analysis
Top Keywords
Similar Publications
Validation of criteria for evaluating competency-based curriculum in medical schools using the Delphi hierarchy process method.
Korean J Med Educ
September 2025
Department of Medical Education, Seoul National University College of Medicine, Seoul, Korea.
Purpose: This study examines the implementation of the competency-based curriculum (CBC), which has become the primary educational model in Korean medical schools. It also presents valid evaluation criteria developed through expert consensus to support ongoing improvements in curriculum quality.
Methods: This study examines the implementation of the CBC, which has become the primary educational model in Korean medical schools.
Predicting venous thromboembolism among hospitalized adults: a protocol for development and validation of an implementable real-time prognostic model.
Diagn Progn Res
September 2025
Department of Biostatistics, Vanderbilt University Medical Center, Nashville, TN, USA.
Background: Hospital-acquired venous thromboembolism (HA-VTE) is a leading cause of morbidity and mortality among hospitalized adults. Numerous prognostic models have been developed to identify those patients with elevated risk of HA-VTE. None, however, has met the necessary criteria to guide clinical decision-making.
View Article and Find Full Text PDFInjectable contraceptive continuation and user experiences in Punjab, Pakistan: a non-randomized prospective cohort study protocol.
BMC Womens Health
September 2025
Jhpiego, Islamabad, Pakistan.
Background: Evidence from multiple pilots and post-introduction scale-up initiatives have demonstrated that self-administered subcutaneous depot-medroxyprogesterone acetate (DMPA-SC) has potential to improve contraceptive continuation rates and expand contraceptive access to populations with limited utilization of facility-based health services. Only a few of these studies have been conducted in South Asian countries, and none where most contraceptive use is of non-hormonal methods that require limited to no contact with the health system, leaving policymakers in countries like Pakistan with limited context-specific evidence to guide decisions on whether, how, and for whom to introduce DMPA-SC.
Methods: A prospective cohort study will be conducted in 41 health facilities and surrounding communities in Punjab, Pakistan.
Revisiting BCG: The potential of rescue BCG therapy for BCG-unresponsive non-muscle-invasive bladder cancer.
Urol Oncol
September 2025
Department of Urology, Columbia University Irving Medical Center, New York, NY.
Objective: To evaluate the role of Rescue BCG in the treatment of BCG-unresponsive nonmuscle-invasive bladder cancer (NMIBC), in order to inform clinical decision-making especially when access to alternative therapies is limited.
Methods: From an institutional database, patients who met the criteria of BCG-unresponsive NMIBC between 2002 and 2023 were identified and sorted into 2 cohorts: those who received additional BCG therapy immediately after BCG-unresponsive designation and those who received alternative treatments such as intravesical chemotherapy and radical cystectomy. Primary endpoint was progression-free survival (PFS).
Understanding the phenomenon of failure to fail in unsafe prelicensure nursing students in the clinical setting: A grounded theory approach.
J Prof Nurs
September 2025
University of Pittsburgh School of Nursing, United States of America. Electronic address:
Background: Failure to fail involves assigning passing grades to students who have not achieved course or clinical objectives at a satisfactory level. The literature has shown that this phenomenon occurs more frequently in the clinical setting due to several issues, including the increased subjectivity of clinical evaluation tools and processes, unclear policies, and lack of administrative support to fail students. The question remains: What is the thought process that is used by faculty to determine if a student passes or fails in a clinical experience?
Purpose: To explore the decision-making process used by pre-licensure clinical nursing faculty when they are determining whether to pass or fail an unsafe student enrolled in a clinical course.