Nih trial studies

Note that if the answers to the 4 questions are yes, your study meets the NIH definition of a clinical trial, even if…. Studies intended solely to refine measures are not considered clinical trials. Studies that involve secondary research with biological specimens or health information are not clinical trials. These simplified case studies illustrate the differences between clinical trials and clinical studies. Print this decision tree for an easy reference for the four questions that identify a clinical trial.

NIH's Definition of a Clinical Trial This page provides information, tools, and resources about the definition of a clinical trial. Correctly identifying whether a study is considered by NIH to be a clinical trial is crucial to how you will: Select the right NIH funding opportunity announcement for your research study Write the research strategy and human subjects sections of your grant application and contract proposal Comply with appropriate policies and regulations, including registration and reporting in ClinicalTrials.

NIH Definition of a Clinical Trial A research study in which one or more human subjects are prospectively assigned prospectively assigned The term "prospectively assigned" refers to a pre-defined process e.

We rapidly translate scientific observations and laboratory discoveries into new ways to diagnose, treat and prevent disease. More than , people from around the world have participated in clinical research since the hospital opened in We do not charge patients for participation and treatment in clinical studies at NIH. In certain emergency circumstances, you may qualify for help with travel and other expenses Read more , to see if clinical studies are for you.

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? Who will be in charge of my care? Personal issues How could being in this study affect my daily life?

How might the study affect my family? Can I talk to other people in the study? Cost issues Will I have to pay for any part of the trial such as tests or the study medicine? If so, what will the charges likely be? What is my health insurance likely to cover?

Read less. Protecting Your Safety - Clinical Trials. Scientific oversight. An IRB approves and monitors most, but not all, clinical trials in the United States to ensure that the risks are minimal when compared with 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. You should ask the research coordinator if an IRB reviewed the research in which you are considering participating. Office for Human Research Protections. Visitors can search by diagnosis, sign, symptom or other key words. ResearchMatch This is an NIH-funded initiative to connect 1 people who are trying to find research studies, and 2 researchers seeking people to participate in their studies.

It is a free, secure registry to make it easier for the public to volunteer and to become involved in clinical research studies that contribute to improved health in the future.

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