People considering taking part in a clinical trial often have questions about the purpose these studies serve, how they work and what it’s like to participate at Montefiore Einstein. Find answers to these and many other common questions below.
Clinical trials test new ways to prevent, detect or treat disease, and to learn if a drug, procedure, medical device or treatment is safe and effective. Virtually every drug and treatment available to patients today has been tested through the clinical trials process.
The first step in the research process involves obtaining informed consent from volunteers. Before any research-related activities begin, the team will explain the study’s purpose, why it is considering a prospective participant to volunteer, what participating would entail (such as the number and type of visits and the duration of the study), potential risks and benefits of participating, and other important considerations. The team will answer any questions about the study and ensure that prospective volunteers have sufficient time to decide if they want to participate.
Here are some questions to ask when deciding whether to volunteer for research:
The potential risks and benefits will vary from study to study and will be explained in detail during the onboarding process. There is a chance that participants will experience side effects from the treatment they receive. The treatment being studied, or the information collected, may benefit the people taking part in the study, but the outcome is not guaranteed.
Yes, you can continue to see your medical doctor when you volunteer for a clinical trial. We recommend that you talk to your doctor about your decision to volunteer.
While many clinical trials require patients to have a particular medical condition, such as cancer or diabetes, many others are open to healthy volunteers.
A placebo is a harmless inactive substance used in some clinical trials to help researchers measure a treatment’s effects compared with receiving no treatment. Not all clinical trials include placebos. Before you agree to participate in a study, you’ll find out if the research will use placebos, and if so, how likely it is you will receive it.
Drugs and tests used in clinical trials are often provided at no cost. But every trial is different, so it's important to ask the research staff about potential costs. This will be discussed during the informed consent process.
Yes. You have the right to change your mind and quit a trial at any time. This will not affect your medical care at Montefiore Einstein.
Clinical trial locations depend on the specific study. If you’re potentially interested, contact the study team to learn more- they can provide detailed information and tell you if there is any compensation for travel related to the study.
The data collected differs for each study. The research staff can answer questions about the study’s purpose that will help you determine if it is something that matters to you.
You may be offered experimental drugs or treatments that are only available through a clinical trial.
Researchers analyze the data collected during the trial to find answers to their research questions. The information researchers look for varies based on the purpose of the trial.
For drug trials, information collected in Phase I and Phase II studies can be used to determine if a drug is safe or to develop additional testing. The U.S. Food and Drug Administration (FDA) evaluates results from Phase III trials to decide if a drug or treatment is safe and beneficial enough to be approved for the public. Information about confidentiality and data sharing will be disclosed during the informed consent process.
- Phase I trials test a drug or other treatment in a small group, typically between 20 and 80 people. The purpose of this phase is to identify side effects, evaluate safety and determine proper dosage and delivery.
- Phase II trials usually involve 100 to 300 volunteers and are meant to assess how safe and effective a treatment is.
- Phase III trials, which typically include at least 1,000 participants, compare the effects of the studied treatment with a placebo or an existing standard of care. This helps researchers determine whether the new treatment compliments, or is superior to, existing options.
- Phase IV trials may be conducted after a treatment has come on the market. These studies can provide more information about longer-term risks, benefits and guidelines for use.
The length of a clinical trial varies based on several factors, such as the type of disease and treatment being tested. Studies involving chronic conditions may be tested over a long period of time, while other trials may only last a few days.
Virtually every drug and treatment available to patients today has been tested by volunteers in clinical trials. While not all trials are successful, the results may lead to medical advancements that benefit other patients or the general population.
Volunteering for a trial
Each study has different requirements. Some need broadly healthy volunteers, while others look for participants with specific medical problems or diseases, such as cancer, diabetes or high cholesterol. Montefiore Einstein clinical trials enroll volunteers from all age groups and with a wide range of health conditions.
- Clinical trials have uncovered decades of important medical discoveries, and the volunteers who participate have helped millions of people improve their health through advances in medical care.
- Because drugs and other therapies can have different effects from one patient to the next, it's important that the volunteers for these studies are diverse. Including all kinds of people in clinical trials helps ensure that new treatments are safe and effective for a wide range of patients.
- People choose to volunteer for many reasons. Some see an opportunity to take a more active role in their own medical care or get earlier access to potentially promising treatments. Many are inspired to help others by contributing to scientific advancement.
Yes. Many clinical trials require healthy participants. This allows researchers to compare data from people who have a particular disease and people who do not.
Each study has its own rules about who can and cannot participate. Your eligibility may be based on your age, sex, overall health, type and stage of a disease, family history, prior treatments, and other conditions.
Some studies reimburse volunteers for their expenses or indirect costs of participating. Examples include time away from work, and travel to and from the research location. Be sure to ask your research team if the study covers these or other costs.
If payment from studies exceeds $600 per year, it is considered taxable income, and volunteers will receive an IRS form 1099 to report the earnings.
Federal regulations provide privacy protections for participants in some clinical trials. We follow these and other strict guidelines to safeguard volunteers’ private health information.
Protecting your privacy, including the confidentiality of your medical records, is something we take very seriously. We take special precautions to safeguard your medical information, including any data that identifies you, when you take part in a clinical trial. For example, whenever possible, researchers use a code instead of your name to associate blood or tissue samples with your medical records.
We work to ensure that your health information and personal identity stay securely within Montefiore Einstein. When we occasionally work with outside researchers, we will only provide your materials anonymously or with a code that only our investigators can access.