Frequently Asked Questions

What is a clinical trial?

Clinical trials are the process by which the Food and Drug administration (FDA) determines whether or not a new drug is safe for human consumption. Clinical trials are conducted in 4 phases. Columbus Clinical Services conducts Phase 2, 3, and 4 studies. Every drug goes through a process of development overseen by the FDA before it is made available to the general public.

What are my rights as a patient?

A patient must meet specific criteria required by the study protocol in order to participate. Not all patients will qualify for one study but will qualify for another. Patients have the choice to enter a study or not. As volunteers, patients have rights that must be protected such as knowing the benefits and risks of participation. Patients have the right to know what tests will be performed and why. Patients also have the right to discontinue participation for any reason without impacting future medical treatment. A written informed consent, approved by an Institutional Review Board, describes the study, risks and benefits of the study. Patient safety is of primary concern regardless of the design or phase of a study. If at any time the physician considers it unsafe for the patient to continue in a study he is obligated remove the patient from the study, discontinue the study medication and prescribe traditional therapy.

What are the benefits of volunteering in a clinical trial?

The benefits of being in a research study include an opportunity to learn more about the medical condition, having access to new medication and treatments before it is made available to the general public, receive excellent medical care at no cost during the study as well as helping others who may benefit from the treatment.

What are the risks of associated with volunteering in a clinical trial?

The risks of participating in a clinical trial include possible discomfort due to due to tests and potential side effects. Participation in the study may not be an effective treatment. The frequent visits to the doctor’s office may cause unexpected disruption in work or family schedules.

What are the phases of clinical trials?

Phase 1

Columbus Clinical Services does not conduct Phase 1 studies. Phase 1 studies usually require overnight stays in a phase 1 facility where a small number of healthy volunteers receive the test drug at low doses. Blood tests are performed frequently to evaluate how it is absorbed in the body and how it is processed before leaving the body. Other tests including stress tests evaluating the effects on the heart are usually performed. Other tests are done in order to evaluate the effects on the liver, kidney, and heart. Safety in humans is the primary purpose of Phase 1 studies therefore, have the highest risk for negative effects than later studies. Phase 1 volunteers should carefully evaluate the reason why they choose to volunteer, especially if it is financially driven.

Phase 2

Phase 2 of drug development tests the investigational medication in patients who have the condition the drug is intended for. Studies are conducted in physician offices, clinics, hospitals, and academic centers. Physicians qualified to conduct the study have extensive experience in their field of medicine and agree to adhere to the laws and regulations pertaining to clinical trials. Although a greater number of patients participate in Phase 2 studies, there are risks involved that you will be explained to patients before they decide to participate. The most effective dose with the least number of side effects is selected to enter Phase 3 clinical trials.

Phase 3

In Phase 3 of drug development, thousands of patients are entered into clinical trials to test for safety and effectiveness of the drug. There are many different studies. The purpose of the study may be to compare the new drug to one that is already on the market. Once the drug company determines adequate study data is collected, the information is submitted to the FDA for review and approval. The FDA will decide to approve or disapprove the drug for marketing. Sometimes additional studies must be conducted.

Phase 4

When a drug is approved by the Food and Drug Administration, the drug company makes it available to the general public. Most drugs are dispensed by prescription so that physicians can closely monitor the safety and effectiveness in their patients. Physicians are asked to report unexpected side effects to the drug company who must in turn submit a report to the FDA. In rare cases a marketed drug causes a severe reaction not reported in clinical trials and is taken off the market. There are risks to taking any medication. Some medication eventually is deemed safe enough for patients to buy without a prescription usually referred to as “over-the-counter” medication.

What is an Institutional Review Board?

An Institutional Review Board (“IRB”) is a committee that reviews research projects involving humans to ensure that the volunteer is not placed at undue risk or unduly persuaded or coerced to enter the study. It is an FDA regulation under Good Clinical Practice (GCP) that Investigators in charge of the conduct of the study site obtain IRB approval and an IRB approved informed consent. An IRB must include a layperson who does not have a scientific background (such as a clergyman) and include both men and women as well as medical professionals. Those directly involved in the research is not able to vote on approval of the study. When the IRB approves a study, they must also approve an informed Consent,which explains the study, risks and benefits, side effects, procedures, compensation and patient rights.

What is Informed Consent?

There is a process of obtaining informed consent that includes reviewing a written informed consent with the patient after communication between the physician and the patient takes place. The communication may begin with someone who the physician authorizes to describe the details of the study. If the patient is interested, the physician should discuss with the patient the diagnosis, nature and purpose of a proposed treatment including risks and benefits, alternative treatment options including risks and benefits, and the risks and benefits of not receiving treatment. If the patient chooses to participate in a clinical trial, a written informed consent form that reiterates what was communicated between the physician and patient is signed and a copy is given to the patient. Signing an Informed Consent, as stated in the document, does not preclude the patient from dropping out of the study at any time for any reason. If a study compensates patients for participation, the amount and payment schedule should be stated in the Informed Consent.