At Global Scientific Innovations we look forward to working with you!  We take great pride in our clinical research training and knowledge of protocol so we can provide you with a safe experience in a research study.  Safety is our #1 focus which is why we go out of our way to properly enroll volunteers with safety in mind and to answer any questions you may have. 

A:    Phase 1 trials
Phase 1 trials usually deal with investigating the studied drug in a minor number of research subjects who are healthy volunteers. This phase is mainly targeted at identifying the safety, tolerability, and the general mechanism of the action of the drug in humans.

Phase 2 trials
The goal of phase 2 trials is to grasp additional understanding of the studied drug'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 to demonstrate relevant results, although the actual number of subjects varies widely based on the disease under study.

Phase 3 trials
Multiple phase 2 studies are often required to define the appropriate patient population to study during phase 3. Once the drug is deemed a potentially safe and effective candidate in Phase 2, it is then studied in Phase 3 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). There is a focus on the effectiveness of the study drug in a variety of demographic and socioeconomic subjects with variants of the disease under study. A comparison is usually made with standard drugs available on the market. It is imperative that the drug is shown to be effective and safe in this phase.

When phase 3 trials are completed (as well as the data demonstrating safety and efficacy of the study drug), a New Drug Application (NDA) containing all manufacturing, pre-clinical, and clinical data is filed with the FDA for review. If deemed safe and effective, the FDA grants approval of the NDA, which then allows the company to market the product. This approval usually comes with strict requirements for the company to conduct additional studies to keep the NDA active (usually involving pediatric trials and additional safety trials).

Phase 4 trials
In phase 4, 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. 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 (but not always), costing billions of dollars.

A:    There are many reasons as to why you should participate in clinical research trials. As a participant, you assist in gathering information about innovative, new treatments that can potentially help your condition and that of millions of other people. You also stand to reap any potential benefits of the new drug or treatment first, in addition to being one of the first people involved in a possibly revolutionary clinical trial that will have a far-reaching impact on the field of medicine.  The increased longevity of humans over the past century can be significantly attributed to advances resulting from medical research.