Cinical trials

Read our disclaimer for details. Before participating in a study, talk to your health care provider and learn about the risks and potential benefits. Learn more. Try the modernized ClinicalTrials. Learn more about the modernization effort. This appointment also gives you a chance to ask your questions about the study. Let your doctor know that you are thinking about joining a clinical trial.

He or she may want to talk to the research team about your health to make sure the study is safe for you and to coordinate your care while you are in the study.

After you consent, you will be screened by clinical staff to see if you meet the criteria to participate in the trial or if anything would exclude you. The screening may involve cognitive and physical tests. Inclusion criteria for a trial might include age, stage of disease, sex, genetic profile, family history, and whether or not you have a study partner who can accompany you to future visits.

Exclusion criteria might include factors such as specific health conditions or medications that could interfere with the treatment being tested. Many volunteers must be screened to find enough people for a study.

Generally, you can participate in only one trial or study at a time. Different trials have different criteria, so being excluded from one trial does not necessarily mean exclusion from another. It is important for clinical trials to have participants of different ages, sexes, races, and ethnicities. When research involves a group of people who are similar, the findings may not apply to or benefit everyone.

When clinical trials include diverse participants, the study results may have a much wider applicability. Researchers need the participation of older people in their clinical trials so that scientists can learn more about how the new drugs, therapies, medical devices, surgical procedures, or tests will work for older people. Many older people have special health needs that are different from those of younger people.

For example, as people age, their bodies may react differently to drugs. Older adults may need different dosages or amounts of a drug to have the right result.

Also, some drugs may have different side effects in older people than younger people. Clinical trials are an important part of the research spectrum. The idea for a clinical trial often starts in the lab. After researchers test new treatments or procedures in the lab and in animals, the most promising treatments are moved into clinical trials.

As studies about new treatments move through a series of steps called phases, researchers learn more information about the treatment, its risks, and its effectiveness. Each clinical trial has criteria describing who can join. Children as well as adults, healthy volunteers and patients, and people of a diverse range of ethnic and racial backgrounds can and are encouraged to participate in clinical trials. Clinical trials follow a plan, called a protocol, that describes what you will be doing and what you can expect from the research team.

It is important to understand the risks and benefits of participation before joining. You also have rights and protections as a participant in clinical trials. Explore this Health Topic to learn more about our role in clinical trials to improve health and where to find more information. Types - Clinical Trials. Purpose of clinical trials. Behavioral trials evaluate or compare ways to promote behavioral changes designed to improve health. Diagnostic trials study or compare tests or procedures for diagnosing a particular disease or condition.

Prevention trials look for better ways to prevent a disease in people who have never had the disease or to prevent the disease from returning. Approaches may include medicines, vaccines, or lifestyle changes. Quality of life trials, or supportive care trials, explore and measure ways to improve the comfort and quality of life for people with conditions or illnesses.

Screening trials test new ways for detecting diseases or health conditions. Treatment trials test new treatments, new combinations of medicines, or new approaches to surgery or radiation therapy. Clinical trial phases. Phase I trials. Researchers test a medicine or other treatment in a small group of people for the first time. The purpose is to learn about the best dose, if it is a medicine, as well as its safety and side effects. Phase II trials. Researchers study the new medicine or treatment in a larger group of people to determine its effectiveness and to further study its safety.

Phase III trials. Researchers give the new medicine or treatment to an even larger group of participants to confirm its effectiveness, monitor side effects, compare it with standard or similar treatments or a placebo , and collect information that will allow the new medicine or treatment to be used safely.

Phase IV trials. After the U. Look for. Read What to Expect to learn about the teams running and supporting a clinical trial, the plan that they follow, and common terms in clinical trial design. What to Expect - Clinical Trials.

Clinical trial experience. Clinical trial protocols. A protocol describes the following: Goals of the study Eligibility requirements Protections against risks to participants Details about tests, procedures, and treatments Expected duration, or how long the study will last Information to be gathered A clinical trial team is led by a principal investigator PI. Clinical trial designs. In single-blind single-masked studies, you are not told what is being given, but the research team knows.

In a double-blind study, neither you nor the research team are told what you are given; only the pharmacist knows. Members of the research team are not told which participants are receiving which treatment, in order to reduce bias. If medically necessary, however, it is always possible to find out which treatment you are receiving. When the study is finished. In many cases, if you participated in a blinded or masked study, you will get information about the treatment you received Ask the research team members if the study results have been or will be published.

Read What to Expect to learn more about what happens during a clinical trial. Read Benefits and Risks to help you decide whether participating in a clinical trial is right for you.

Who Can Participate - Clinical Trials. Healthy volunteers. Patient volunteers. Patients may volunteer for studies similar to those in which healthy volunteers take part. Diverse volunteers. Eligibility criteria. Benefits and Risks - Clinical Trials. Possible benefits. Well-designed and well-performed clinical trials provide benefits to you, while allowing you to help others by contributing to knowledge about new treatments or procedures.

You gain access to new research treatments before they are widely available. You receive regular and careful medical attention from a research team that includes doctors and other healthcare professionals. Possible risks.

Clinical trials do come with some risks. Most clinical trials pose the risk of minor discomfort, which often lasts only a short time. However, some study participants experience complications that require medical attention. Control groups, randomisation and blinding If you take part in a clinical trial, you'll usually be randomly assigned to either the: treatment group — where you'll be given the treatment being assessed, or control group — where you'll be given an existing standard treatment, or a placebo if no proven standard treatment exists While the treatments are different in the 2 groups, researchers try to keep as many of the other conditions the same as possible.

What should I know before I sign up? You'll also be given some printed information to take away. You may come back with some questions you feel have not been answered. General questions What's the aim of the trial and how will it help people? Who's funding the trial?

What treatment will I get if I do not take part in the trial? How long is the trial expected to last, and how long will I have to take part? How long will it be before the results of the trial are known? What will happen if I stop the trial treatment or leave the trial before it ends? What would happen if something went wrong? It's rare for patients to be harmed by trial treatments, but you may want to ask about compensation if this were to happen.

Practical questions How much of my time will be needed? Will I need to take time off work? Will I be paid? Will the costs of my travel to take part in the trial be covered?

If the trial is testing a new drug, will I have to collect it from the hospital, will it be sent to me by post, or will I get it through my doctor? Will I have to complete questionnaires or keep a diary? What are the possible side effects of my treatment?

How could the treatments affect me physically and emotionally? Who can I contact if I have a problem? Will someone be available 24 hours a day? How do I find out the results of the trial? Things to weigh up As with any treatment, you cannot be sure of the outcome. Also, it's possible you'll experience unexpected side effects.