Clinical Trial FAQs

As defined by the International Conference on Harmonisation (ICH), a clinical trial is any investigation in human subjects intended to:

• Discover or verify the clinical, pharmacological, and/or other pharmacodynamic effects of an investigational product(s), and/or
• Identify any adverse reactions to an investigational product(s), and/or
• Study absorption, distribution, metabolism, and excretion of an investigational product(s) with the object of ascertaining its safety and/or efficacy.

People choose to participate in clinical research for reasons as individual as they are. Clinical trials can either enhance treatment, or be a treatment option. Some people seek clinical trials when other treatment options have not been successful. ;Others choose to participate to help others.

Here are just a few of the many reasons people choose to participate in these studies:

• Successful clinical trials may improve the length and quality of life for study participants.
• Clinical trials provide an opportunity to take positive action by contributing to the understanding of a disease or condition and by furthering treatment options available to others.
• Including a diverse population in clinical research helps provide results to our diverse population

Advances in medicine and science are the result of new ideas and approaches developed through research. New treatments must prove to be safe and effective in scientific studies with a certain number of patients before they can be made widely available. Through clinical trials, researchers learn which approaches are more effective than others and is the best way to test a new treatment. Clinical research studies also provide more information about how the human body or mind works and helps expand scientific knowledge.

Clinical research is sponsored and funded by a variety of organizations:

• Private companies such as pharmaceutical and medical device companies.
• National Institutes of Health (NIH) or other federal agencies such as the Department of Defense (DOD).
• Academic medical institutions or not-for-profit organizations such as the American Heart Association (AHA).

The benefits, disadvantages, and risks of a clinical research studies are listed in the consent form which must be read and signed by each study participant before the trial occurs.

Benefits

• During the time of participation in a clinical research study, patients may benefit from a research medication or treatment long before it is available to the general public.
• Throughout the trial, patients receive careful medical attention.
• There might be extra examinations and tests which will not be billed to patients or their insurance companies.
• Some patients consider it a benefit that they are contributing to medical science.

Disadvantages

• The main disadvantage to participating in a clinical research study is the time commitment. During the trial, additional office visits or laboratory tests are sometimes needed. Although the patient may not be required to pay for these extra services, they often can be time consuming. However inconvenient, some trials do provide payment for travel-related expenses.
• Some clinical trials require participants to discontinue use of their regular treatment/medication before the trial begins. Depending on the treatment/medication, there is a possibility of a short time of increased discomfort until the new treatment begins to work.
• With any treatment, there is always a possibility that the study treatment will not have any effect, or worse, a negative effect on a patient.

Risks

As with other treatments, those used in clinical research may cause side effects that vary from person to person. Because the research treatments being tested in a clinical trial may be relatively new, it is possible that unknown side effects could occur. Before the trial begins, the risks and possible side effects specific to the clinical research project must be listed in the consent form and discussed by the research team with each participant.

A variety of people can participate in clinical research. Every protocol identifies a specific set of characteristics that study subjects should have in order to participate in the study. These characteristics are called eligibility criteria. They may include the type of disease or condition and its stage, as well as the age and general health of the participants.

Clinical trials are one type of clinical research. Clinical trials fall into one of four main categories:

1. Treatment Trials

   Designed to test new treatments, new drugs, new medical devices, or new medical procedures.

2. Prevention Trials

   Examine better or new ways to prevent disease from occurring or reoccurring. The methods being tested in the trial may involve drugs, lifestyle changes, dietary modifications, or vaccines.

3. Screening Trials

   Examine methods of detecting disease or health problems.

4. Quality of Life Trials

   Designed to find ways to improve the quality of life and comfort level of those with chronic illnesses.

Informed consent is the process by which the study team explains all processes, potential risks/benefits, and the overall realm of a study to a study participant so that he/she understands and can make an appropriate decision on whether or not he/she would like to participate.

• Informed consent is required in studies that are federally regulated or funded as well as by many state laws.
• The informed consent process is an ongoing process. If you enter a trial, you will continue to receive any new information about your treatment that may affect your willingness to stay in the trial. 
• Signing a consent form does not bind you to the study. You can still choose to leave the study at any time.

The study participant is given an informed consent form that lists the benefits, disadvantages, and risks of the clinical research study. This form should be read and considered carefully and any questions the participant may have should be asked and explained thoroughly. After all aspects have been considered by the participant, the form can be signed.