What is a medical trial

Some studies need volunteers with a certain disease. Some need healthy people. Others want just men or just women. It is an independent committee of physicians, statisticians, and members of the community.

Its role is to:. In the United States, a clinical trial must have an IRB if it is studying a drug, biological product, or medical device that the Food and Drug Administration FDA regulates, or it is funded or carried out by the federal government.

The information on this site should not be used as a substitute for professional medical care or advice. Contact a health care provider if you have questions about your health. Clinical Trials. They are conducted after the FDA has approved a drug for commercial sale. Although at this point researchers have already tested a new drug on thousands of people and received approval, they still may not know its full effects and may have further questions.

For example, in a cancer trial, a drug may have been shown to decrease cancer cells and tumors. Phase IV trials are meant to address these types of follow-up questions. Sometimes, phase IV trials end with the FDA taking a drug or treatment off the market or placing restrictions on a product. In cancer trials, phase IV studies are uncommon. In vaccine clinical trials, phase IV studies look for the rare adverse effects and the long-term efficacy that may emerge, because viruses and bacteria can evolve over the long haul, sometimes making a vaccine less effective.

For new medicines, phase IV trials can require thousands of participants. In these cases, researchers collect data on a new drug and monitor its performance regarding the disease or condition. Although phase IV is the safest of clinical trials, investigators still continue to review the drug for safety issues. The minimum period for phase IV is two years. Should I think about joining a clinical trial? The answer differs for everyone, depending on a number of factors including whether you are healthy or have the condition or illness under study.

If you are considering joining a clinical trial , you should be well informed; you might ask yourself questions that include:.

If you have an illness or condition, clinical trials may help you by discovering the following : an effective treatment for you; a treatment more effective than the one you are currently receiving; a treatment that you tolerate better than the one you are currently receiving; or confirmation of a new use for an already existing treatment.

In any study, there are risks. This report outlines the requirements for human subject research by offering three main tenets:. The principles apply particularly to the Institutional Review Boards IRBs , who are responsible for vetting all humans subject research proposals prior to testing.

Most people who enroll in clinical trials do so at the suggestion of their doctor, due to a specific illness or condition. There are many sources in the U. At the very least, these sources provide you with the name, general location, contact information, patient eligibility criteria, and description of the trial.

For the United States, check these sites:. The first thing you do in a clinical trial is give researchers your written, informed consent to be part of the study. Informed consent in studies is the voluntary approval for treatment by a patient who has full knowledge of the possible risks and consequences.

Some studies then collect blood or imaging data before you start treatment. They may also take your full medical history. These tests determine if you are eligible to be in the study and make sure you are safe to proceed. During treatment, you may have additional tests performed to see how you are doing. The researchers will also be looking for any adverse effects.

You should report to the researchers with anything out of the ordinary in your medical or physical status. This way, they can review whether these symptoms are related to the study. Given the nature of these clinical trial protocols, you will be receiving more medical attention for your illness than you would normally receive. You do not need to participate in all phases of a clinical trial.

Your medical care is given to you by doctors deciding your unique, individual requirements. The goal of your medical treatment is to help you and make you feel better. Clinical trials follow a specified protocol that necessarily applies to all the participants.

This protocol may be advantageous to you, but it also may not be. A clinical trial is an experiment; therefore, the outcome is assumed but not known or confirmed until after the trial is complete. Overall, it is important to remember that clinical trials are meant to research, not to give proven effective medical care to the individual. Inclusion and exclusion criteria are often related to age, gender, previous or current medications, other existing medical conditions, and recent participation in another clinical trial.

To be in a clinical trial, you must satisfy both the inclusion and exclusion criteria, which are developed to protect the participants and public and maintain the integrity of the research.

Prospective participants should keep in mind that some studies are looking for healthy participants and some are looking for participants that have the condition or illness. The voluntary nature of informed consent also allows participants to discontinue participation in a clinical trial at any time, without the loss of benefits or penalty for something they are otherwise entitled to.

The researchers are also required to safely help their subjects withdraw from studies safely. They must explain their reasons for removing them from the study, and as appropriate, explain to them other available treatment options. Subjects may be removed from a study if they are not following the study procedures or are deliberately providing false information, as this behavior would put the integrity of the study at risk.

Subjects may also be removed from a study if the researchers consider them at excessive risk or at risk with a demonstrated lack of benefits.

An example of this would be if the participants had serious adverse side effects without the projected therapeutic effects. You have clearly defined rights at all stages of a clinical trial. Before a trial, you will be given information to help you make the best decision for you about whether you participate in the trial.

You will also have informed consent. You will understand the benefits, risks, study length, where it will be conducted, and what will be expected of you during the trial. You can and should ask questions and talk about any concerns you have. You can decline participation or withdraw from a study at any time. You will also be apprised of any findings that come out during the study that may affect your participation.

Your medical information and data will be kept strictly confidential. You also have the same Patient Bill of Rights that any other patient receiving medical care can expect. Your team of researchers and medical care providers have a legal, ethical, and safety responsibility.

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Try Smartsheet for free, today. In This Article. What Are Clinical Trials? See how Smartsheet can help you be more effective. The Development Process of Clinical Trials The attempt to discover a viable new medication, treatment, or therapy is known as the discovery process.

During experimentation, scientists gather the following kinds of information: Mechanisms of action Possible benefits How the body absorbs, metabolizes, and excretes a drug Potential routes of administration How a drug interacts with other medications How one can produce a drug for administration After development, researchers perform preclinical research, using good laboratory practices GLP.

Types of Clinical Trials Clinical trials come in two main varieties: Observational: This type of clinical trial monitors conditions and health over time. The patients in these trials may be receiving treatment, but they are not assigned to specific interventions. Interventional: These are what most people think of when they think of clinical trials — the studies that assign interventions, such as drugs or experimental treatments, to patients with an illness or condition.

Scientists can also assign clinical trials to the following study categories: Treatment Trials: These trials test medicine or treatment protocols on patients with a specific illness. Prevention Trials: These trials test such preventive measures as vaccines or interventions that may lower the risk for developing a specific condition or illness.

Prevention trials may be broken down into action or agent studies. Screening Trials: These trials test ways of detecting an illness or condition, especially in its preliminary stages. Palliative Trials: These trials look for protocols or approaches to improve the comfort or quality of life of someone living with an illness or condition. Genetic Trials: These trials look for the inherited risk of a condition or illness.

The literature on clinical research describes several types of studies that have published results: Case Series: Also called clinical series , these observational studies track patients who have the designated condition or illness. Often considered half of a case-control study, case series alone have no control group.

The members of a control group are not afflicted with the condition or illness under study. The patients in case series studies often receive the same intervention. 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.

Rarely, participants have experienced serious or life-threatening complications resulting from their participation in trials of experimental treatments. The study may require more time and attention than standard treatment would, including visits to the study site, more blood tests, more procedures, hospital stays, or complex dosage schedules.

See a list of questions to ask your doctor and the research staff. Read more. The study What is the purpose of the study? Why do researchers think the approach may be effective? Who will fund the study? Who has reviewed and approved the study? How are study results and safety of participants being monitored?

How long will the study last? What will my responsibilities be if I take part? Who will tell me about the results of the study and how will I be informed? Possible benefits and risks What are my possible short-term benefits? What are my possible long-term benefits? What are my short-term risks and side effects?

What are my long-term risks? What other options are available? How do the risks and possible benefits of this trial compare with those options? Will they hurt, and if so, for how long? How do the tests in the study compare with those I would have outside of the trial? Will I be able to take my regular medicines while taking part in the clinical trial?

Where will I have my medical care? FDA staff meet with researchers and perform inspections of clinical trial study sites to protect the rights of patients and to verify the quality and integrity of the data. Learn more about the Drug Development Process. One good way to find out if there are any clinical trials that might help you is to ask your doctor.

Other sources of information include:. A placebo is a pill, liquid, or powder that has no treatment value. It is often called a sugar pill. In clinical trials that include placebos, quite often neither patients nor their doctors know who is receiving the placebo and how is being treated with the experimental drug.

Many cancer clinical trials, as well as trials for other serious and life-threatening conditions, do not include placebo control groups. In these cases, all participants receive the experimental drug.

Ask the trial coordinator whether there is a chance you may get a placebo rather than the experimental drug. Then, talk with your doctor about what is best for you. Talk to the clinical trial coordinator to find out which phase the clinical trial is in.