When doing clinical trials on medications for human beings, there are several phases that the drug must go through. The first phase, or ‘Early Phase’ studies are used to measure the safety and efficacy of an investigational new drug before it is marketed to the general public.
The Early Phase study of a clinical trial is the phase of the clinical trial that determines the best new treatment regime and what doses can be safely given. The Early Phase studies generally involve a small group of participants, from 20-80 individuals, and these individuals are the study group that allows the drug to be measured at the maximum safe dose and what the toxicity levels are, which, in turn, a properly controlled trial.
When the FDA reviews the Early Phase, it confirms that subjects are not unduly exposed to unreasonable risks. The participants of the Early Phase studies are healthy subjects to ensure that the baseline of the Early Phase study is accurate. However, the FDA may also enroll participants who have contracted the disease to see how the drug affects the disease.
Early Phase studies are critical to the development of the drug in question. Most participants are paid a small stipend for their involvement in the Early Phase study, which raises the standard of consistency in the continuation of the participant in the study.
Richmond Pharmacology prides itself as being the only CRO to have not just Standard Early Phase studies, but Supplementary MHRA Phase 1 Accreditation for 2 trial centres in Europe.