Frequently Asked Questions
What is a Clinical Trial?
A clinical trial, also referred to as a clinical research study, is a scientific study that evaluates the safety, effectiveness and side effects of investigational medicine(s), treatment(s), or device(s) on a group of volunteers. Clinical trials are an important step in making new medications available for future use. The U.S. Food and Drug Administration (FDA) requires the satisfactory completion of clinical trials before it will approve a new treatment as safe and effective for public use.
Why Do People Become Involved in Clinical Trials?
For a physician, Clinical trials give you the opportunity to offer your patients new medical therapies that you would not have access to otherwise. Importantly, they also provide additional financial resources to supplement your practice.
As a patient, volunteering to participate in a clinical drug study is one of the best ways you can contribute to the understanding of diseases that affect people and to the development of new therapies.
What are the Risks Involved in Clinical Trials?
With each clinical trial, you are given information outlining the pros and cons of the drug or device being researched. Adverse events, sometimes serious in nature, are a possibility. You are closely monitored by the physician, as well as the study team, to treat any such event. Most study participants are not negatively affected by the drug or device that they are assisting in researching, but if something does happen, your study team will address it and respond to you quickly. You will be provided a 24-hour answer telephone contact number for such events or any other study related concerns that you might have.
What is a Placebo?
A placebo is a benign substance designed to resemble the drug being tested. It is used as a control to rule out any bias. Most well-designed studies include a control group which is unwittingly taking a placebo.
Do all Clinical Trials Include Placebos?
Each study is designed individually and therefore the use of placebos is based on that study design. A large majority of trials are placebo laced trials, however stage IV trials typically are not balanced with a placebo as a control.
Where are the Clinical Trials Performed?
Our clinical research trials are performed in participating physician practices in the Western PA region.
Are Volunteers Required to Pay for Participation in Clinical Trials?
No. Participation is free to the study participant. Often the study participant receives travel reimbursement, and always will receive medical care, laboratory testing, and medication at no cost.
Is the Privacy of Participants Respected?
CCT and the participating physicians are governed under HIPPA, therefore will not disclosure any information that is considered to be protected under this Federal Act.
How Do People Become Involved in a Clinical Trial?
Please call Consolidated Clinical Trials 412-273-9100 or visit Become Involved
Can People Be Enrolled in a Clinical Trial without their Knowledge?
No. Patients must give written consent before any research procedure can be performed.