It's natural to have many questions about clinical trials, and it's important to get them answered. Below are answers to the most frequently asked questions about clinical trials, and information on how to contact the AIDS Cancer Clinic (ACC) staff.
What is a clinical trial?
A clinical trial is a careful research study that examines the benefits and risks of news drugs or new drug combinations. There are several types of clinical trials:
Phase 1: Study medication given to a small group of people to measure a drug's safety.
Phase 2: Study medication given to larger groups of people to measure a drug's safety and effectiveness.
Phase 3: Study medication given to very large groups of people to verify a drug's safety and effectiveness.
What drugs are tested?
ACC staff test different kinds of medications, including the following:
- Medications to treat HIV and AIDS
- Medications to prevent or treat related infections
- New medicines still in testing
- Medications approved by the Food and Drug Administration (FDA) that are used in new ways or in new combinations
Why are Clinical Trials Important?
Researchers conduct clinical trials with the goal of finding new and better treatments and vaccines to prevent and cure the serious diseases of mankind, such as HIV and cancer. These treatments and vaccines are tested in volunteers through clinical trials to ensure that they are safe and effective.
How safe is a clinical trial?
The ethical and legal codes that govern medical practice also apply to clinical trials. Some people are concerned about previous unsafe studies such as the Tuskegee Syphilis Study, which was conducted before the government established strong ethical guidelines for the conduct of clinical trials. The Tuskegee Syphilis Study was an unfortunate event in American science. Many important safeguards and changes have been made since then. The federal government now has strict rules and regulations that all researchers must follow to protect participants in clinical trials.
Clinical researchers are federally regulated with built in safeguards to protect the participants. The OSU Institutional Review Board (IRB) is an ethics committee that reviews each study to make sure the research is obeying the law and that the treatment plans are as safe as possible. All studies provide at least the current recommended care. If the IRB approves the study, by law, the researchers must clearly inform volunteers of all known risks involved in the trial before the study. Volunteers must also provide their consent before participating in a research study.
In addition, all studies must monitor the data collected and the safety of the participants and the treatments during the study. In some trials, this is done through an independent group of experts called the Data Monitoring Committee (DMC), sometimes known as the Data and Safety Monitoring Board (DSMB). This process ensures that the risks of trial participants are reduced as much as possible and that the information collected is accurate and useable. In rare cases, a trial may be stopped early, either because the participants are being exposed to too much risk, or because the trial has already answered the questions it was designed to explore.
Why should I volunteer to enroll in a clinical trial?
There are many good reasons to enroll in a clinical trial. Volunteers are the first to have access to new drugs not yet available to the public. Participants are provided expert medical care and are closely monitored by physicians and nurses while on study drugs, which are provided free of charge. Volunteers also have an opportunity to help others by contributing to medical research aimed at finding better treatments for HIV infection. You owe it to yourself to learn about clinical trials. Talk first with your doctor and loved ones.
What are the risks of being in a clinical trial?
Investigational drugs may not work, may be less beneficial than expected, or may be harmful. Study drugs may have unanticipated side effects. Protocols also require a commitment of time for trips to the research unit.
What if I decide to enroll and then change my mind?
Participation is 100 percent voluntary. It is your right by law to quit any research study at any time for any reason. When withdrawing from a clinical trial, the participant should let the research team know about it, and the reasons for leaving the study.
Do I need my own doctor?
Yes. With your permission, your doctor will receive lab results and other health updates while you are in a research study. If you need a doctor, expert HIV specialty and primary care is available by appointment. Click here if you need a doctor.
How will I know what studies (protocols) are available?
After enrolling in the ACC program, volunteers are kept informed of all new studies. You can also revisit this site as clinical trial information will be updated regularly.
What questions should I ask as I consider enrolling in a clinical trial?
Before beginning participation in a research protocol, all volunteers are given a detailed explanation of the study. If you are considering a protocol you may want to ask these questions:
- What is the purpose of the study?
- What is being studied?
- What are the drug(s') side effects?
- Will placebos (sugar pills that look like the study drug but do not contain the medication) be used during the protocol?
- What are the other possible risks?
- What other treatment options do I have?
- How long will the study last?
- How often will I need to visit the clinic?
- What lab tests are needed?
- Who will pay the costs of the study? What costs, if any, will I have to pay?
- Will I have a chance to continue receiving the study medication after the trial ends?
- How soon after completing the trial will I learn which treatment I was receiving?
- When will I get the study results?
Who provides my care at the ACC?
Protocol care is provided by a staff of registered nurses and physician specialists trained in providing cancer care (hematology and oncology). The ACC physicians are members of The Ohio State University Medical Center staff and are either faculty or fellows in Ohio State's College of Medicine. In addition, all research volunteers must have a primary care doctor for their routine medical care. If you already have a primary care physician, we want to provide this doctor with information about your research program participation. For this reason we ask that you bring the name, address, and phone number of your doctor to your first appointment.
If you do not have a physician, we can help you locate one. Expert medical care is available on site at The Ohio State University Hospitals Clinics, and referrals for dental, psychological, nutritional and legal services can also be made. Our patient navigator and nurses can also provide you with information about support groups and other community services.
Are my ACC records confidential?
We recognize the sensitive nature of HIV infection and our staff appreciates the importance of confidentiality. No records are ever released without your written permission. A special release form must be signed by you before any records are released. We ask for your permission to keep your doctor informed of your health and your progress in the research program.
Are there any charges for services at the ACC?
Most studies are funded by a federal research grant. Additional studies are sponsored by pharmaceutical companies. Screening visits (to determine if you are eligible for a protocol) are always free and there are no charges for the experimental medicines on the research studies. On some studies, the physician visits and/or laboratory tests are also free. Because our funds do not cover routine medical care, usual medical care expenses are the patient's responsibility.
Before you enroll in any study you will be told if there are any charges associated with the study. Please let the screening counselor know if you anticipate any financial difficulties. No one is ever denied access to studies because of an inability to pay related expenses.
Can I use my health insurance if there are charges for my protocol?
If there are any expenses on your protocol, with your permission, we will bill your insurance company. Because many insurance plans restrict which hospitals and doctors that must be used, please verify your coverage. Also, please note that all insurance companies require medical information when claims are submitted. Your authorization to file a claim automatically authorizes the insurer to have access to your medical record. If you prefer not to use your insurance, bills can be sent directly to you. Please tell our receptionist to mark your account as "self-pay"
How do I join a clinical trial?
Call us at 614-293-3196, option 2 and ask for our screening nurse. All patient information is kept strictly confidential. Click here for a list of open trials.
For more information on Clinical Trials, please visit: