Welcome to the M. Brian Aynesworth Research Center!
The mission of the M. Brian Aynesworth Research Center is to provide high quality Phase II to Phase IV clinical research in an experienced and professional environment. All studies are conducted according to study protocols, the Declaration of Helsinki concerning medical research and in accordance with federal laws and regulations relating to research.
Samina Ali, MD, CCRP, CCRA
Julia Armstrong, RN, BSN, CCRP
Clinical research is a branch of medical science that determines the safety and effectiveness of medications, devices, diagnostic products and treatment regimens intended for human use.
The term clinical research refers to the entire biography of a drug from its inception in the lab to its introduction to the consumer market and beyond. Once the promising candidate or the molecule is identified in the lab, it is subjected to pre-clinical studies or animal studies where different aspects of the drug (including its efficacy and toxicity) are studied. The data obtained from the pre-clinical studies are submitted as an Investigational New Drug (IND) to the Food and Drug Administration (FDA) for permission to conduct human studies.
Heading the research team is Dr. Samina Ali. Dr. Ali completed medical school in Karachi, Pakistan with a focus in internal medicine and brings a background of patient care experience as well as a foundation in the sciences to her role as research coordinator.
Phase I Trials
Phase I trials usually deal with investigating the studied drug or device in a small number of research subjects who are healthy volunteers. This phase is targeted at identifying the safety, tolerability and the general mechanism of the action of the drug in humans.
Phase II Trials
The goal of Phase II trials is to grasp additional understanding of the studied drug or device’s safety and efficacy. It also determines the appropriate dose to be administered to deliver the desired treatment effect while minimizing the safety risk of future research subjects. This usually requires more than 100 patients with the target disease to demonstrate relevant results and may consist of placebo use or comparison drugs or both.
Phase III Trials
Once the drug or device is deemed potentially safe and effective, it is then studied in Phase III trials. This phase often exposes more than 1000 research subjects with the disease, and is usually performed at many clinics (sometimes well over 100) to enroll the trial (or trials). Phase III trials focus on the effectiveness of the study drug/device in a variety of demographic and socioeconomic subjects with variants of the disease under study. A comparison is usually made with standard drugs/devices available on the market. It is imperative that the drug/device is shown to be effective and safe in this phase.
Phase IV Trials
In Phase IV, the aim is to further characterize the safety of the drug through the identification of unknown adverse reactions and to potentially research new therapeutic indications. This phase is often referred to as the Post-Marketing Study. Companies often use this phase to gain exposure to different physicians and clinics, which aids in the marketing of their product. The entire process of a drug from lab to market may take approximately 12 to 18 years.