If you take part in a randomized clinical trial, you may not have a choice about which treatment you get. If the study is blinded, you (and maybe your doctor) won’t know which treatment you’re getting. (This information will be available to the clinical trial team as needed for your safety). Insurers may not cover all costs of the clinical trial.
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Why would I be interested in joining a clinical trial?
Before joining a clinical trial, it is important to learn as much as possible. Discuss your questions and concerns with members of the health care team conducting the trial.
What are the rules for participating in a clinical trial?
· They may also measure different variables (such as blood pressure or cholesterol level) or do other testing to assess a person’s health status. A clinical trial is type of study in which volunteers receive a new treatment, which may be a medication, a procedure, or a device. Most often, volunteers are randomly assigned to receive either the ...
Is everyone who applies for a clinical trial accepted?
Clinical trials look at new ways to prevent, detect, or treat diseases. Treatments might be new drugs or new combinations of drugs, new surgical procedures or devices, or new ways to use …
Should people with cancer take part in clinical trials?
Yes, all clinical trials have risks. But any medical test, treatment, or procedure has risks. The risk may be higher in a clinical trial because there are more unknowns. This is especially true of …
What are the criteria for clinical trials?
Researchers also use a variety of criteria—including age, blood test results, and other medical conditions—to include or exclude people from a trial. This helps protect the participants’ safety and ensures the investigators get the information they need.
What is the process of consent for research?
Anyone who volunteers for a research study must undergo a process known as informed consent, which is designed to help them clearly understand what to expect as well as the risks and benefits of participating. An independent committee known as an Institutional Review Board ensures the study is performed in a way that protects the rights and welfare of the participants.
What is the Framingham Heart Study?
One of the most famous studies is the long-running Framingham Heart Study, which has yielded a wealth of information about the causes of heart disease and stroke. It’s an example of a cohort study, which follows a large group of people over a long period of time. Through questionnaires or interviews, researchers gather information on a wide range of things—diet, exercise, and medical and family history, for example. They may also measure different variables (such as blood pressure or cholesterol level) or do other testing to assess a person’s health status.
Why is extra medical attention important?
On the other hand, the extra medical attention—which is in addition to your usual care—may be helpful, because any changes in your health are more likely to be noticed. Another potential advantage is access to new therapies before they are widely available or affordable, although in any clinical trial, you won’t know if you get the new treatment or not, notes Dr. Cannon.
Who is the executive director of Cardiometabolic Trials at Harvard?
In fact, you’ve already benefited from all the people who took part in earlier clinical research,” says Harvard professor Dr. Christopher Cannon, executive director of Cardiometabolic Trials at the Harvard Clinical Research Institute.
Does Harvard Health Publishing have archived content?
As a service to our readers, Harvard Health Publishing provides access to our library of archived content. Please note the date of last review or update on all articles. No content on this site, regardless of date, should ever be used as a substitute for direct medical advice from your doctor or other qualified clinician.
Do you have to join a study?
Nothing obligates you to join a study, but it’s an option worth examining. “If you participate in a study, you’ll be advancing scientific knowledge to help the next patient like you. In fact, you’ve already benefited from all the people who took part in earlier clinical research,” says Harvard professor Dr. Christopher Cannon, executive director of Cardiometabolic Trials at the Harvard Clinical Research Institute.
Why do people participate in clinical trials?
A study’s benefits may be indirect for the volunteers but may help others. People participate in clinical trials for a variety of reasons. Healthy volunteers say they participate to help others and to contribute to moving science forward. Participants with an illness or disease also participate to help others, but also to possibly receive ...
Why are clinical trials approved?
Most, but not all, clinical trials in the United States are approved and monitored by an Institutional Review Board (IRB) in order to ensure that the risks are minimal and are worth any potential benefits. An IRB is an independent committee that consists of physicians, statisticians, and members of the community who ensure that clinical trials are ethical and that the rights of participants are protected. Potential research participants should ask the sponsor or research coordinator whether the research they are considering participating in was reviewed by an IRB.
What are the risks of participating in a clinical study?
Most clinical studies pose the risk of minor discomfort, which lasts only a short time. However, some study participants experience complications that require medical attention. In rare cases, participants have been seriously injured or have died of complications resulting from their participation in trials of experimental therapies. The specific risks associated with a research protocol are described in detail in the informed consent document, which participants are asked to read and sign before participating in research. Also, a member of the research team explains the major risks of participating in a study and will answer any questions you have about the study. Before deciding to participate, carefully consider possible risks and benefits.
What is clinical trial?
What is a clinical trial? Clinical trials are part of clinical research and at the heart of all medical advances. Clinical trials look at new ways to prevent, detect, or treat diseases. Treatments might be new drugs or new combinations of drugs, new surgical procedures or devices, or new ways to use existing treatments.
What are the criteria for participation in a clinical trial?
All clinical trials have guidelines about who can participate, called inclusion/exclusion criteria. Factors that allow someone to participate in a clinical trial are “inclusion criteria.”. Those that exclude or do not allow participation are “exclusion criteria.”. These criteria are based on factors such as age, gender, ...
Why is clinical research important?
By placing some people at risk of harm for the good of others, clinical research has the potential to exploit patient volunteers. The purpose of ethical guidelines is both to protect patient volunteers and to preserve the integrity of the science.
How to join a study?
Once you find a study that you might want to join, contact the clinical trial or study coordinator. You can usually find this contact information in the description of the study. The next step is a screening appointment to see if you qualify to participate. This appointment also gives you a chance to ask your questions about the study.
What happens if a clinical trial is not working?
If they find that the experimental treatment is not working or is harming participants, they will stop the trial right away. The informed consent process also helps protect participants. Before joining a clinical trial, you will be told what to expect as a participant and all the things that might happen.
What are the benefits of clinical trials?
What are the Benefits of a Clinical Trial? 1 You may get a new treatment for a disease before it is available to everyone. 2 You play a more active role in your own health care. 3 Researchers may provide you with medical care and more frequent health check-ups as part of your treatment. 4 You may have the chance to help others get a better treatment for their health problems in the future. 5 You may be able to get information about support groups and resources.
What are the rules that researchers must follow?
Researchers are required to follow strict rules to make sure that participants are safe. These rules are enforced by the Federal Government. Each clinical trial also follows a careful study plan or protocol that describes what the researchers will do.
Why do researchers provide you with medical care?
Researchers may provide you with medical care and more frequent health check-ups as part of your treatment. You may have the chance to help others get a better treatment for their health problems in the future.
Who is responsible for approving clinical trials?
The principal investigator, or head researcher, is responsible for making sure that the protocol is followed. An Institutional Review Board, or IRB, at each study site must approve every clinical trial in the United States. The IRB is made up of doctors, scientists, and lay people, like yourself, who are dedicated to making sure ...
Can you be part of a control group?
Instead, you may be part of the control group, which means you get the standard treatment or a no-treatment placebo. The clinical trial could inconvenience you. For example, medical appointments could take a lot of time. You might need to travel to the study site several times or stay in the hospital.
Can a new treatment cause side effects?
The new treatment may cause serious side effects or be uncomfortable.
Why are people concerned about clinical trials?
Most people have some concerns about taking part in a clinical trial because they’re not really sure what it will mean for them. Get as much information as you need to make the choice that’s right for you.
What is the information needed for a clinical trial?
Information that’s needed for the clinical trial, such as test results, is put on special forms and into computer systems. This is only shared with the people who analyze the study results. Your data is given a number or code – your name isn’t on the forms or in the study system.
Why are randomized clinical trials so distressing?
Some people find the concept of randomized clinical trials distressing, since neither the patient nor the doctor can choose which group the patient is in. This can be especially true if a trial is looking at totally different treatments and a person believes that one is better than the other.
What happens if you are blinded in a clinical trial?
If the study is blinded, you (and maybe your doctor) won’t know which treatment you’re getting. (This information will be available to the clinical trial team as needed for your safety). Insurers may not cover all costs of the clinical trial. They usually do cover the costs of what would normally be standard care.
What are the benefits of clinical trials?
But for the most part, clinical trials (other than phase 0) have some of the same potential benefits: You might help others who have the same disease by helping to advance cancer research. You could get a treatment that’s not available outside of the trial.
Why is the risk of cancer higher in clinical trials?
The risk may be higher in a clinical trial because there are more unknowns. This is especially true of phase I and II clinical trials, where the treatment has been studied in fewer people. Perhaps a bigger question is if the possible benefits outweigh the risks. People with cancer are often willing to accept a certain amount ...
Why do we need to test a new treatment against a placebo?
In rare cases, testing a new treatment against a placebo might be needed to prove that the treatment is better than nothing at all. The very least you should expect from any clinical trial is to be offered the treatment standard of care.
What is a clinical trial protocol?
Every clinical trial has a protocol, or study plan, that describes what will be done during the trial, how the trial will be conducted, and why each part of the trial is necessary. The protocol also includes requirements that must be met for you to join a clinical trial. These requirements are called eligibility criteria.
What are the benefits of a cancer trial?
Possible Benefits. You will have access to a new treatment that is not available to people outside the trial. The research team will watch you closely. If the treatment being studied is more effective than the standard treatment, you may be among the first to benefit. The trial may help scientists learn more about cancer and help people in ...
Why are people taking part in trials alike?
When people taking part in a trial are alike in key ways, researchers can be more certain that the results are due to the treatment being tested and not to other factors. Some people have health problems besides cancer that could be made worse by the treatments in a trial.
What are the eligibility criteria for a cancer treatment?
Common eligibility criteria include: Having a certain type or stage of cancer. Having received (or not having received) a certain kind of therapy in the past. Having specific genetic changes in your tumor. Being in a certain age group.
Is new treatment better than standard treatment?
Possible Risks. The new treatment may not be better than, or even as good as, the standard treatment. New treatments may have side effects that doctors do not expect or that are worse than those of the standard treatment. You may be required to make more visits to the doctor than if you were receiving standard treatment.
Does insurance cover immunotherapy?
Health insurance may not cover all patient care costs in a trial. A cancer survivor and a clinical researcher tell about taking part in an immunotherapy clinical trial at NCI's Center for Cancer Research.
Do you have to make more visits to the doctor?
You may be required to make more visits to the doctor than if you were receiving standard treatment. You may have extra expenses related to these extra visits, such as travel, housing, and childcare costs.
What are the factors that allow you to participate in a clinical trial?
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. Back to top. 6.
What is clinical trial?
A clinical trial can sometimes require more time and medical attention than normal care. This can include doctor visits, phone calls, more treatments, a hospital stay, or a more complicated treatment regimen. (Ask your doctor for information about the trial you are considering.)
How many clinical trials are there at MSK?
MSK researchers run one of the world’s largest clinical cancer research programs. Patients who choose to participate in one of our more than 900 clinical trials benefit from our large number of options, the close collaboration between our doctors and scientists, and the oversight of a compassionate and highly experienced staff recognized for their unparalleled focus on patient safety and care.
What is informed consent?
Informed consent is the process of learning about the clinical trial before you decide to take part in it. The research team running the trial will explain the trial’s purpose, how long it will take, what will happen, all potential risks and benefits, and information on the privacy of your medical records.
What are the benefits of clinical trials?
1. What are the potential benefits of participating in a clinical trial? 1 You may gain access to new drugs and other treatments, sometimes years before they are widely available. 2 You will be monitored closely for any side effects. 3 You will have the chance to take an active role in your own healthcare. 4 You will be making a valuable contribution to cancer research.
Where are MSK trials located?
We offer care related to clinical trials — including phase I trials — at many of our locations in Manhattan, New Jersey, Long Island, and Westchester County. MSK trials are also offered through our MSK Cancer Alliance partners in Hartford, Connecticut, and Lehigh Valley, Pennsylvania.
When is a placebo used in cancer treatment?
A placebo in cancer treatment is most commonly used when a standard treatment is available to patients and we want to compare that standard treatment to a new treatment. Back to top. 4.
Why do people participate in clinical trials?
Why participate in a clinical trial? Participants in clinical trials can play a more active role in their own health care, gain access to new research treatments before they are widely available, and help others by contributing to medical research.
Why do clinical trials need to be approved?
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 an independent committee of physicians, statisticians, community advocates, and others that ensures that a clinical trial is ethical and the rights of study participants are protected. All institutions that conduct or support biomedical research involving people must, by federal regulation, have an IRB that initially approves and periodically reviews the research.
How do clinical trials work?
They check the health of the participant at the beginning of the trial, give specific instructions for participating in the trial, monitor the participant carefully during the trial, and stay in touch after the trial is completed. Some clinical trials involve more tests and doctor visits than the participant would normally have for an illness ...
Why are experimental treatments compared to placebos?
In clinical trials, experimental treatments are often compared with placebos to assess the experimental treatment's effectiveness. In some studies, the participants in the control group will receive a placebo instead of an active drug or experimental treatment.
What is inclusion criteria in clinical trials?
Using inclusion/exclusion criteria is an important principle of medical research that helps to produce reliable results. The factors that allow someone to participate in a clinical trial are called "inclusion criteria" and those that disallow someone from participating are called ...
What is clinical trial?
Although there are many definitions of clinical trials, they are generally considered to be biomedical or health-related research studies in human beings that follow a pre-defined protocol. ClinicalTrials.gov includes both interventional and observational types of studies.
What is interventional study?
Interventional studies are those in which the research subjects are assigned by the investigator to a treatment or other intervention , and their outcomes are measured. Observational studies are those in which individuals are observed and their outcomes are measured by the investigators.
What Are The Benefits of A Clinical Trial?
- You may get a new treatment for a disease before it is available to everyone.
- You play a more active role in your own health care.
- Researchers may provide you with medical care and more frequent health check-ups as part of your treatment.
- You may have the chance to help others get a better treatment for their health problems in th…
- You may get a new treatment for a disease before it is available to everyone.
- You play a more active role in your own health care.
- Researchers may provide you with medical care and more frequent health check-ups as part of your treatment.
- You may have the chance to help others get a better treatment for their health problems in the future.
What Are The Potential Risks of A Clinical Trial?
- The new treatment may cause serious side effectsor be uncomfortable.
- The new treatment may not work, or it may not be better than the standard treatment.
- You may NOT be part of the treatment group (or experimental group) that gets the new treatment—for example, a new drug or device. Instead, you may be part of the control group, which means you get...
- The new treatment may cause serious side effectsor be uncomfortable.
- The new treatment may not work, or it may not be better than the standard treatment.
- You may NOT be part of the treatment group (or experimental group) that gets the new treatment—for example, a new drug or device. Instead, you may be part of the control group, which means you get...
- The clinical trial could inconvenience you. For example, medical appointments could take a lot of time. You might need to travel to the study site several times or stay in the hospital.
How Is The Safety of Clinical Trial Participants Protected?
- This is a very important question. The history of clinical research is not perfect. Based on many years of experience and learning, Congress has passed laws to protect study participants. Today, every clinical investigator is required to monitor and make sure that every participant is safe. These safeguards are an essential part of the research. Research abuses like the Tuskegee Syp…
For More Information About Clinical Trials
- This content is provided by the NIH National Institute on Aging (NIA). NIA scientists and other experts review this content to ensure it is accurate and up to date. Content reviewed: May 17, 2017