Clinical Research

No Cost Clinical Trials

Clinical Trials are research studies that explore whether a medical strategy, treatment, or device is safe and effective for humans. These studies also may show which medical approaches work best for certain illnesses or groups of people. A clinical trial involves two or more people who have volunteered for a particular medical study. These trials vary in length – some take only a day or two while others go on for multiple years. Clinical research involves people like you. When you volunteer to take part in clinical research, you help doctors and researchers learn more about a disease and improve health care for people in the future.

Researchers follow clinical trial guidelines when deciding who can participate in a particular study. These guidelines are called Inclusion/Exclusion Criteria. Factors that allow you to take part in a clinical trial are called “inclusion criteria.” Those that exclude or prevent participation are “exclusion criteria.” These criteria are based on factors such as age, gender, the type and stage of a disease, treatment history, and other medical conditions. Not everyone who wants to volunteer will be accepted. Physical exams and other medical procedures may be required to determine your ability to participate in the trial.

This is done to ensure that it is completely safe for each person to participate in the research, and there is never any cost to the volunteer. Most clinical trials provide a time and travel stipend.

Your Privacy and Safety

We protect the privacy of every volunteer we work with and will hold your medical information under the strictest confidence. Every person’s privacy is guaranteed by the Health Insurance Portability and Accountability Act of 1996, also known as HIPAA, and we fully adhere to its guidelines.

Informed consent is the process of learning the key facts about a clinical trial before deciding whether to participate. The process of providing information to participants continues throughout the study. To help you decide whether to take part, members of the research team explain the study. The research team provides an informed consent document, which includes such details about the study as its purpose, duration, required procedures, and who to contact for various purposes. The informed consent document also explains the risks and potential benefits. If you decide to enroll in the trial, you will need to sign the informed consent document. You are free to change your mind about participating in the trial at any time.

Benefits of Trial Participation

Clinical Trials are essential to the medical community because they are required before any new form of medication can be approved for use. Scientists are constantly looking for new methods to combat illnesses, cure diseases and improve the quality of life for terminal patients. Volunteers are always needed to advance the progress of medications that will help people and save lives. Many people sign up to help make these new medications available to patients who need them, and others join to try out a new drug that may improve a condition they are suffering from.

Only through clinical research can we gain insights and answers about the safety and effectiveness of treatments and procedures. Groundbreaking scientific advances in the present and the past were possible only because of participation of volunteers, both healthy and those with an illness, in clinical research. Clinical research requires complex and rigorous testing in collaboration with communities that are affected by the disease. As research opens new doors to finding ways to diagnose, prevent, treat, or cure disease and disability, clinical trial participation is essential to help us find the answers.

Volunteering for a Clinical Research Trial

The goal of clinical research is to develop knowledge that improves human health or increases understanding of human biology. People who take part in clinical research make it possible for this to occur. The path to finding out if a new drug is safe or effective is to test it on patients in clinical trials.

When you join a Clinical Trial you will be working with experienced professionals who are dedicated to your personal safety. They will work closely with you throughout the entire process to answer all of your questions and monitor any effects that the medication has on you. Every Trial is also regulated by guidelines created by the Food and Drug Administration and monitored by members of the Institutional Review Board to ensure that each participant is well cared for. The safety of everyone involved is the top priority.

After the Trial

A Clinical Trial is just one step in a long process to get any new medication approved. If the medication is shown to be safe and effective, a New Drug Application will be submitted to the FDA. The FDA will then review the application and thoroughly investigate the results of the Trial. In some cases more Trials may be required to study particular aspects of the medication. A new medication is only approved for the public when the FDA’s stringent requirements are met completely.