What Is a 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 . 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. A clinical trial is a research study that helps doctors develop better medications and treatments.

Each clinical trial looks at specific questions about how treat, prevent, diagnose, or detect different diseases or medical conditions. The knowledge gained in clinical trials can improve medical care for future patients.

A clinical trial follows a specific plan describing exactly how the study will be conducted and why each part of the study is important. Although clinical trials are often conducted at several locations at the same time, this plan ensures that every doctor performs the study in the same way.

Are Clinical Trials Dangerous?

Every clinical trial that takes place at a medical research facility, such as a hospital or university, must be reviewed and approved by a board of physicians, researchers, and community members.

This helps ensure that the study is conducted fairly and that the participants aren’t harmed.

However, clinical trials still involve some degree of risk for participants. Before making the decision to volunteer for a clinical trial, it is important to understand exactly what is involved in the study.

When looking at a clinical trial, two important things to consider are the chance of harm—that is, the likelihood that particular side effects will occur—and the degree of harm—that is, the seriousness of potential side effects. In most cases, volunteers risk only minor, temporary discomfort.

In some cases, though, more serious medical complications are possible. Very rarely, volunteers have been seriously injured or died as a result of treatment received in a clinical trial.

Every person who joins a clinical trial must first sign a consent document that explains the research study in clear language. He or she will also meet with a member of the research team, who will explain the study, the volunteer’s role, and answer any questions.

Deciding whether to participate in a clinical trial is an important personal decision. Many find it helpful to discuss the study with friends, family, or a physician before choosing whether to participate. Study participants may choose to withdraw from a clinical at any time. Frequently Asked Questions -

What Are the Different Types of Clinical Trials?

There are several different types of clinical trials.

 - Prevention trials help doctors determine whether particular medications, vitamins, or other treatments lower the risk of developing a disease, such as lung cancer.

- Screening and diagnostic trials look for better ways to detect and accurately identify diseases.

- Quality of life trials look for ways to improve the comfort of patients. For example, this type of trial might provide new ways to prevent nausea and vomiting caused by chemotherapy.

- Treatment trials test the effectiveness of new drugs and treatments compared to those that already exist. Treatment clinical trials are almost always conducted in a series of three steps, called phase 1, phase 2, and phase 3 clinical trials. 

Phase 1 - clinical trials focus on the safety and side effects of the trial drug.  They usually enroll only a small number of volunteers. The first volunteers receive a low dose, to see how well they can tolerate the drug.

The dose is increased a little at a time over the course of the trial so that researchers can learn how the drug acts inside the body, the maximum safe dosage, and possible side effects. The maximum safe dosage is used for later studies.

Phase 2 - A Phase 2 clinical trial is larger study that helps researchers to learn more about the drug, how the body uses it, and the drug’s effectiveness. Depending on the success of the tested drug or treatment, some participants benefit from the treatment received in a phase 2 study.

If a drug or treatment looks promising in phase 1 and 2 trials, it moves on to a phase 3 clinical trial.

Phase 3 - In a phase 3 trial, researchers compare a new drug to the current standard treatment for the condition being studied. This type of clinical trial helps researchers figure out the best way to use the new drug.

Phase 3 trials are usually conducted at multiple locations and include large numbers of volunteers.

Sometimes, a drug or treatment also goes through a phase 4 clinical trial to evaluate its long-term safety and effectiveness.

What Is a Clinical Trial?

A clinical trial is a research study that helps doctors develop better medications and treatments. Each clinical trial looks at specific questions about how treat, prevent, diagnose, or detect different diseases or medical conditions.

The knowledge gained in clinical trials can improve medical care for future patients. A clinical trial follows a specific plan describing exactly how the study will be conducted and why each part of the study is important.

Although clinical trials are often conducted at several locations at the same time, this plan ensures that every doctor performs the study in the same way. Frequently Asked Questions -