Clinical trials are research studies that explore a medical treatment or device for its safety and efficacy in people. These studies seek to find which medical approaches work best for certain illnesses or groups of people. Clinical trials follow strict scientific standards, called protocols, which are designed to protect patient safety and help produce reliable, dependable study results.
The process often begins in a laboratory, where scientists first develop and test new ideas and drugs. If a new approach shows promise, doctors then test the treatment in people, usually in 3 or 4 phases.
- In Phase 1 clinical trials, researchers test a new drug or treatment in a small group of people (20-80) for the first time to evaluate its safety, determine a safe dosage range, and to identify side effects.
- In Phase 2 clinical trials, the study drug or treatment is given to a larger group of people (100-300) to see if it is effective and to further evaluate its safety.
- In Phase 3 studies, the study drug or treatment is given to large groups of people (100s-1,000s) to confirm its effectiveness, monitor side effects, compare it to commonly used treatments and to continue to collect information that will allow the drug or treatment to be used safely.
- Phase 4 studies are conducted after the drug or treatment has been approved by the FDA and marketed, meaning doctors can now prescribe the drug regularly. These studies continue testing the study drug or treatment to collect information about its effectiveness in various populations and any side effects associated with long-term use.
You may be able to take part in clinical trials that include investigational drugs, diagnostic tests, medical devices, or preventative measures. Clinical trials offer patients the opportunity to access the newest possible treatments, and many patients feel good about being part of a process that helps improve the healthcare options for life-threatening and chronic diseases. To learn more about any of our trials, you can speak with any of our OHC doctors or contact our Research Department at 1-800-710-4674.
All clinical trials have eligibility criteria to ensure the new drugs are only given to the appropriate patients. The factors that allow you to participate in a clinical trial can include age, gender, the type and stage of your disease, previous treatment history and other medical conditions. Following eligibility criteria helps us keep you safe and ensures that researchers learn the information they need. Your OHC doctor will be able to discuss the eligibility criteria with you to make sure you are informed and can make the best decision for your care.
At OHC, we believe consideration to participate in a clinical trial should be a first step in your care. However, you can join at any time during your treatment if you meet the trial protocol’s eligibility requirements. We have clinical trials available for patients who are newly diagnosed, and studies for patients who are further along in their treatment.
Yes. Clinical trials are completely voluntary. Patients can withdraw at any time without penalty. We simply ask that you inform your OHC doctor of your decision to withdraw so we can adequately update your records and discuss other treatment possibilities.
Yes. OHC is the only practice in the region where some of the trials are available, so doctors will refer their patients to OHC to give them access to clinical trial opportunities. If you are interested in clinical trial options, discuss your interest with your doctor or you can call OHC at 1-800-710-4674.
Every clinical trial must be approved and monitored by an Institutional Review Board (IRB) to make sure the study is ethical and that the potential benefits outweigh the potential risks. All institutions that conduct or support biomedical research involving people must, by federal regulation, have an IRB that approves and periodically reviews the research to ensure your safety. Once the trial is approved by the IRB, the organizers of the study must follow a careful plan, called a protocol, that describes exactly what will happen during the study. You will know the full details of the protocol prior to joining any clinical trial, and participation is completely voluntary.
You may gain early access to the newest drugs or treatments that are not available to the general public, and you will be helping researchers in their work to find better cancer treatments. Participating in clinical trials helps bring newer, better treatment options into regular use, which helps ensure future generations have better options for their healthcare.
Before you enroll in a study, you will meet with your doctor, nurse navigator, or research nurse who will inform you of trials that match your situation, as well as any potential risks and benefits. All this information will be provided in writing in what’s called an Informed Consent Form. You will have time to discuss the trial options with your healthcare team and OHC will make sure all your questions are answered.
People participate in clinical trials for a variety of reasons. Healthy volunteers say they participate to help others, and to contribute to the advancement of cancer treatments so future generations have better healthcare options. Participants with an illness or disease also participate to help others, but also to possibly receive the newest treatments that are not yet available to the general public.
No. You can stay with your current OHC doctor even if you sign up for a clinical trial led by another OHC doctor.
One of the best benefits of OHC’s clinical trials program is that they are offered in many of our offices located in Greater Cincinnati. Click here for OHC office locations.
Yes. If you are an OHC patient, please call OHC at 1-800-710-4674 and we will connect you with patients who have already taken part in a clinical trial.