Frequently Asked Questions

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A clinical research study involves testing an investigational product which can be a  drug or a device in humans. Each clinical research study requires the use of a protocol that has been written according to government regulations such as FDA and IRB and that is also approved by the company sponsoring the study. 

Phase II

This phase studies assist in determining how safe and effective the investigational product is. This study phase reveals the following data for the investigational product; amount of drug that gets into the bloodstream, how quickly it gets there and how long it stays there for. It will also reveal the effects of the drug in the body. These studies are commonly conducted in subjects who have the medical condition for which the investigational product is being researched. 

Phase III

This phase studies serve to obtain additional information about the safety and efficacy of the investigational product when used in the way it is intended to be marketed for. This phase is approved after the earlier phases have demonstrated that the risk of the investigational product is outweighed by the potential benefit of the investigational product to the patient. This phase assists in confirming the indication and best usage for the investigational product.

Phase IV

This phase studies are conducted after the investigational product is made available for sale and its safety and effectiveness has been evaluated when exposed to the intended population. In this phase the study evaluates parameters such as different formulations, dosages, treatment durations, and drug interactions. This phase assists in obtaining data for previously unknown or inadequately quantified adverse events and related risk factors. 

• Be the first to benefit from obtaining a cutting-edge investigational product before they become available to the public
• Receive medical care at no cost
• Obtain compensation for participation and/or transportation 
• Help others obtain better medical treatment in the future by contributing to research 

The majority of Investigational Products cause side effects and/ or other health risks. These risks might not be known ahead of time as clinical research evaluates new medical treatments. Rest assured, there are safeguards put in place to protect the safety of the study participants throughout the trial. 

Placebo is commonly known as the “sugar pill”. A placebo simply means that it’s a pill, liquid, or powder that doesn’t contain any medical treatment value. Placebo is key in clinical research to assist in assessing the treatment’s effectiveness by being compared with the investigational product.