How long do trials last

Phase 1: These trials usually enroll 20 to healthy volunteers or people with the condition being studied, and last several months. This phase measures safety by testing for any adverse side effects of the treatment, but not necessarily how effective the drug or device is.

Phase 2 trials recruit up to several hundred patients with the condition to take part. This phase typically lasts several months to two years. This phase measures both safety and effectiveness with many volunteers, sometimes thousands.

Phase 3 trials last from one to four years. The FDA then reviews results from all stages of the trial to determine whether it will approve the drug and allow the pharmaceutical company to begin marketing it to the public. It may take time for long-term side effects to appear, making this an important phase.

When you're considering taking part in a clinical trial, ask the study team about the schedule of the trial. Some trials may last for several years, but only require visits every few months, for example. Clinical studies can be sponsored, or funded, by pharmaceutical companies, academic medical centers, voluntary groups, and other organizations, in addition to Federal agencies such as the National Institutes of Health, the U.

Department of Defense, and the U. Department of Veterans Affairs. Doctors, other health care providers, and other individuals can also sponsor clinical research. Clinical studies can take place in many locations, including hospitals, universities, doctors' offices, and community clinics.

The location depends on who is conducting the study. The length of a clinical study varies, depending on what is being studied. Participants are told how long the study will last before they enroll. In general, clinical studies are designed to add to medical knowledge related to the treatment, diagnosis, and prevention of diseases or conditions.

Some common reasons for conducting clinical studies include:. A clinical study is conducted according to a research plan known as the protocol. The protocol is designed to answer specific research questions and safeguard the health of participants.

It contains the following information:. Clinical studies have standards outlining who can participate. These standards are called eligibility criteria and are listed in the protocol. Some research studies seek participants who have the illnesses or conditions that will be studied, other studies are looking for healthy participants, and some studies are limited to a predetermined group of people who are asked by researchers to enroll.

The factors that allow someone to participate in a clinical study are called inclusion criteria, and the factors that disqualify someone from participating are called exclusion criteria. They are based on characteristics such as age, gender, the type and stage of a disease, previous treatment history, and other medical conditions. Informed consent is a process used by researchers to provide potential and enrolled participants with information about a clinical study.

This information helps people decide whether they want to enroll or continue to participate in the study. The informed consent process is intended to protect participants and should provide enough information for a person to understand the risks of, potential benefits of, and alternatives to the study. In addition to the informed consent document, the process may involve recruitment materials, verbal instructions, question-and-answer sessions, and activities to measure participant understanding.

In general, a person must sign an informed consent document before joining a study to show that he or she was given information on the risks, potential benefits, and alternatives and that he or she understands it.

Signing the document and providing consent is not a contract. Participants may withdraw from a study at any time, even if the study is not over. See the Questions to Ask section on this page for questions to ask a health care provider or researcher about participating in a clinical study. Grow Your Legal Practice. Meet the Editors. Speedy Trial Rights However, once criminal proceedings have begun with the filing of charges , defendants can generally force them to move relatively quickly. In or Out?

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