The selection of a suitable method for assessment of glaucomatous progression and estimation of rates of change is an essential component of the design of clinical trials investigating neuroprotective therapies for the disease. Due to the limitations of currently available tests, approaches combining structural and functional tests are essential in order to provide reliable detection of endpoints. This could also potentially enable shorter clinical trials with relatively smaller sample size requirements. A recent approach for estimating rates of retinal ganglion cell loss using a combination of structural and functional tests has been shown to perform better than isolated parameters from conventional tests for diagnosing, staging and detecting glaucoma progression and may prove useful as an outcome measure in clinical trials of the disease.
Download full-text PDF |
Source |
---|---|
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3784261 | PMC |
http://dx.doi.org/10.1016/j.coph.2012.10.010 | DOI Listing |
Clin Trials
January 2025
Department of Medicine, Harvard Medical School, Boston, MA, USA.
Background/aims: People with disability have higher rates of cancer, excluding skin cancer, compared with people without disability. Food and Drug Administration draft guidelines from 2024 address use of performance status criteria to determine eligibility for clinical trials, advocating for less restrictive thresholds. We examined the exclusion of people with disability from clinical trials based on performance status and other criteria.
View Article and Find Full Text PDFClin Trials
January 2025
Department of Biostatistics, University of Washington, Seattle, WA, USA.
Background: N-of-1 trials compare two or more treatment options for a single participant. These trials have been used to study options for chronic conditions such as arthritis and attention deficit hyperactivity disorder. In addition, they have been suggested as a means to study interventions in rare populations that may not be tractable to include in standard clinical trials, such as treatment options for HIV-positive patients in need of organ transplant.
View Article and Find Full Text PDFClin Trials
January 2025
Central Monitoring and Data Analytics, GSK, Brentford, UK.
Background: Clinical trials handle a huge amount of data which can be used during the trial to improve the ongoing study conduct. It is suggested by regulators to implement the remote approach to evaluate clinical trials by analysing collected data. Central statistical monitoring helps to achieve that by employing quantitative methods, the results of which are a basis for decision-making on quality issues.
View Article and Find Full Text PDFMuscle Nerve
January 2025
Center for Gene Therapy, Abigail Wexner Research Institute, Nationwide Children's Hospital, Columbus, Ohio, USA.
Background: Nusinersen and risdiplam are U.S. Food and Drug Administration (FDA)-approved treatments for spinal muscular atrophy (SMA).
View Article and Find Full Text PDFEur J Breast Health
January 2025
Department of Pharmaceutics, Faculty of Pharmacy, Sri Ramachandra Institute of Higher Education and Research, Chennai, India.
Breast cancer remains one of the most prevalent malignancies among women globally. Despite advances in therapeutic options, the prognosis often remains challenging. Breast cancer typically originates in the epithelial lining of glandular tissue ducts (85%) or lobules (15%).
View Article and Find Full Text PDFEnter search terms and have AI summaries delivered each week - change queries or unsubscribe any time!