Frequently Asked Questions
What is a clinical trial?
Once a proposed treatment or medicine is found to be helpful and safe in test tubes and in animals, it must also prove safe and effective in humans. This evaluation period is known as a clinical trial. Clinical trials, also called research studies or protocols, help doctors find new and better ways to prevent, detect, diagnose, control and treat illnesses.
What do researchers learn from clinical trials?
There’s a whole range of valuable information gained through clinical trials. Trials make it possible for researchers to:
- Develop new treatment options for a medical condition
- Improve upon or find new ways to use existing treatments
- Develop new screening and diagnosing techniques
- Improve disease prevention practices
- Enhance the quality of life of patients and communities
It’s uncommon that any given trial addresses all of the above outcomes, but every trial sets out to accomplish at least one of them. Often, clinical trials yield unexpected benefits, such as when an advancement for one medical condition is also seen to improve another condition. Part of a researcher’s job is to stay informed of the findings of other researchers. In this way, the knowledge accumulates, stimulates more focused study and increases the likelihood for discoveries that improve people’s lives.
What sorts of trials are most common at HHDC?
Most of our clinical trials are drug studies, and there are four types of these:
- Phase 1 studies enroll a small number of volunteers to help determine the best dosage and potential side effects of a newly developed medication.
- Phase 2 studies expand the trial to a larger number of volunteers to learn more about side effects, how the body uses the drug, and how the drug helps the condition treated.
- Phase 3 studies compare the effectiveness of the new medication with other drugs, typically better known and already on the market, to determine whether the new drug treats the condition better or has fewer side effects.
- Phase 4 studies occur after a drug is approved for market (i.e. is available to be prescribed by people like your family physician). In Phase 4, researchers gather information on the drug’s effect among various populations and any side effects associated with long-term use.
Phases 1-3 take years — sometimes decades — to complete, and theoretically, Phase 4 continues indefinitely. This rigorous process helps ensure the public’s access to medications that are effective and safe.
If a clinical trial is enrolling at HHDC that is not a drug trial, we will provide you with details on that study here on our website or in printed materials, well before you decide to volunteer.
How can I be sure a clinical trial is safe for my participation?
Safety is by far the highest concern of the parties involved in medical research, and the federal government mandates strict rules for compliance at all levels.
First, every clinical trial in the U.S. must be approved and monitored by an Institutional Review Board (IRB) to make sure the risks are as low as possible and are worth any potential benefits. An IRB is a committee of physicians, statisticians, patient advocates, and other members of the community that reviews the protocol, or study plan, to ensure that the study is ethical and that participants are not likely to be harmed. If a study appears to be causing unexpected harm to participants, or if there is evidence that the risks outweigh the benefits, the IRB is empowered to stop the study.
In addition, researchers and physicians conducting a clinical trial, including those of us at Harold Hamm, are bound by strict rules designed, monitored and enforced by the NIH and FDA. Any breach of these rules could result in serious consequences for the researchers, up to and including criminal prosecution. There is always an approved protocol associated with every trial, and we are required to follow it exactly as written.
What is involved in the trial enrollment process?
First, we’ll ask you several questions about your health and will typically schedule an appointment with you to conduct a screening. The data we collect from you helps determine whether you’re eligible to enroll in one or more of our current studies.
After we determine that you’re eligible to participate, you have the opportunity to decide whether you want to. The decision to volunteer in a clinical trial is a very personal one. However, there are guidelines to protect study participants. Testing in humans is permitted only in volunteers who have been briefed about the purpose of the study as well as the potential benefits and hazards of trial participation. This is called informed consent. It is the responsibility of the trial’s medical team to explain the risks to potential study participants.
We will provide you with an informed-consent form with detailed information about the study, including its length, the number of visits required, medical procedures, and medications included. It also provides expected outcomes, potential benefits and possible risks. These forms are provided through the IRB, so that every study participant, no matter where they are in the world, has identical information.
We encourage you to take time with the informed-consent form and discuss trial participation with your physician and family. To guide your decision process, the NIH developed the following set of questions, which your HHDC trial coordinator and your personal physician can help you answer:
- What is the purpose of the study?
- What is required of me?
- What is my role in the study? Am I a healthy volunteer or a patient volunteer?
- Will the study directly benefit me?
- Will the study benefit others?
- Are there risks? If so, what are they and what are the chances that they will occur?
- What discomforts are involved?
- What is the total time involved?
- Are there other inconveniences?
- Have I discussed participation in the study with those who are important to me, such as family and friends?
- Do I wish to participate in this study?
Be sure that you feel comfortable with your answers before signing the informed-consent form.
What if I enroll and then change my mind?
The informed-consent form is not a contract. Your participation is 100-percent voluntary, from start to finish. You may leave a study at any time for any reason.
With so many locations available for clinical trials, why should I volunteer through Harold Hamm?
While we stop short of claiming we’re “better” than other trial sites, there are a couple things you might take into consideration. First, HHDC is a center of excellence at the University of Oklahoma, and our academic research component carries significant weight among the worldwide clinical trials community. Many diabetes-related studies choose only a few sites in the world based on their specialized diabetes expertise, and HHDC is commonly selected among these.
Additionally, when you’re a clinical trial volunteer at HHDC, you’re in the care of diabetes professionals, not just medical professionals. Two of HHDC’s three study coordinators are certified diabetes educators, and all of our staff undergoes intensive, ongoing training in diabetes and its complications. We go the extra mile to leverage your clinical trial as part of your life-long diabetes treatment, not just a temporary investigation. We want you to feel comfortable and grow healthier while you’re with us, and you’ll be surrounded at Harold Hamm by world-class diabetes patient-care resources, should you ever need them.