Bottin C, Grieve K, Rossant F, Pedinielli A, Mrejen S, Paques M DIRECTIONAL VARIABILITY OF FUNDUS REFLECTANCE IN ACUTE MACULAR NEURORETINOPATHY: EVIDENCE FOR A CONTRIBUTION OF THE STILES-CRAWFORD EFFECT. Retin Cases Brief Rep. 2018 Fall;12 Suppl 1:S19-S2
Faure C, Gocho K, Le Mer Y, Sahel JA, Paques M, Audo I Functional and high resolution retinal imaging assessment in a case of ocular siderosis. Doc Ophthalmol. 2014 Feb;128(1):69-75. doi: 10.1007/s10633-013-9421-y. Epub 2013 Dec 13.
Faure C, Paques M, Audo I Electrophysiological features and multimodal imaging in ritonavir-related maculopathy. Doc Ophthalmol. 2017 Dec;135(3):241-248. doi: 10.1007/s10633-017-9612-z. Epub 2017 Sep 12.
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.