Bhorade AM, Gordon MO, Wilson B, Weinreb RN, Kass MA; Ocular Hypertension Treatment Study Group Variability of intraocular pressure measurements in observation participants in the ocular hypertension treatment study. Ophthalmology. 2009 Apr;116(4):717-24. doi: 10.1016/j.ophtha.2008.12.036. Epub 2009 Feb 25. Erratum in: Ophthalmology. 2009 May;116(5):822. Weinrab, Robert N [corrected to Weinreb, Robert N].
Chen Z, Wang K A gene-based test of association through an orthogonal decomposition of genotype scores. Hum Genet. 2017 Oct;136(10):1385-1394. doi: 10.1007/s00439-017-1839-y. Epub 2017 Sep 1.
Gao F, Miller JP, Beiser JA, Xiong C, Gordon MO Predicting Clinical Binary Outcome Using Multivariate Longitudinal Data: Application to Patients with Newly Diagnosed Primary Open-Angle Glaucoma. J Biom Biostat. 2015 Oct;6(4). pii: 254. Epub 2015 Oct 26.
Gao F, Miller JP, Miglior S, Beiser JA, Torri V, Kass MA, Gordon MO A Joint Model for Prognostic Effect of Biomarker Variability on Outcomes: long-term intraocular pressure (IOP) fluctuation on the risk of developing primary open-angle glaucoma (POAG). JP J Biostat. 2011 May 1;5(2):73-96.
Gordon MO, Gao F, Beiser JA, Miller JP, Kass MA The 10-year incidence of glaucoma among patients with treated and untreated ocular hypertension. Arch Ophthalmol. 2011 Dec;129(12):1630-1. doi: 10.1001/archophthalmol.2011.337.
Gordon MO, Kass MA The Ocular Hypertension Treatment Study: design and baseline description of the participants. Arch Ophthalmol. 1999 May;117(5):573-83.
Gordon MO, Kass MA What We Have Learned From the Ocular Hypertension Treatment Study. Am J Ophthalmol. 2018 May;189:xxiv-xxvii. doi: 10.1016/j.ajo.2018.02.016. Epub 2018 Mar 1. Review.
Kass MA, Gordon MO, Kymes SM Incorporating the results of the Ocular Hypertension Treatment Study into clinical practice. Arch Ophthalmol. 2005 Jul;123(7):1021-2.
Kymes SM, Plotzke MR, Kass MA, Boland MV, Gordon MO Effect of patient's life expectancy on the cost-effectiveness of treatment for ocular hypertension. Arch Ophthalmol. 2010 May;128(5):613-8. doi: 10.1001/archophthalmol.2010.83.
Wang K Conditional asymptotic inference for the kernel association test. Bioinformatics. 2017 Dec 1;33(23):3733-3739. doi: 10.1093/bioinformatics/btx511.
Interventional studies are often prospective and are specifically tailored to evaluate direct impacts of treatment or preventive measures on disease.
Observational studies are often retrospective and are used to assess potential causation in exposure-outcome relationships and therefore influence preventive methods.
Expanded access is a means by which manufacturers make investigational new drugs available, under certain circumstances, to treat a patient(s) with a serious disease or condition who cannot participate in a controlled clinical trial.
Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.
Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.