Should i participate in a clinical trial

A clinical study involves research using human volunteers also called participants that is intended to add to medical knowledge. There are two main types of clinical studies: clinical trials also called interventional studies and observational studies. In a clinical trial, participants receive specific interventions according to the research plan or protocol created by the investigators.

These interventions may be medical products, such as drugs or devices; procedures; or changes to participants' behavior, such as diet. Clinical trials may compare a new medical approach to a standard one that is already available, to a placebo that contains no active ingredients, or to no intervention.

Some clinical trials compare interventions that are already available to each other. When a new product or approach is being studied, it is not usually known whether it will be helpful, harmful, or no different than available alternatives including no intervention.

The investigators try to determine the safety and efficacy of the intervention by measuring certain outcomes in the participants. For example, investigators may give a drug or treatment to participants who have high blood pressure to see whether their blood pressure decreases. Clinical trials used in drug development are sometimes described by phase. Some people who are not eligible to participate in a clinical trial may be able to get experimental drugs or devices outside of a clinical trial through expanded access.

See more information on expanded access from the FDA. In an observational study, investigators assess health outcomes in groups of participants according to a research plan or protocol. Participants may receive interventions which can include medical products such as drugs or devices or procedures as part of their routine medical care, but participants are not assigned to specific interventions by the investigator as in a clinical trial.

For example, investigators may observe a group of older adults to learn more about the effects of different lifestyles on cardiac health. Every clinical study is led by a principal investigator, who is often a medical doctor. Clinical studies also have a research team that may include doctors, nurses, social workers, and other health care professionals.

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. You will not be a guinea pig, but it's true that the purpose of a clinical trial is to answer a medical question. People who take part in clinical trials may need to do extra things or have certain tests done as part of the clinical trial.

In fact, most people enrolled in clinical trials welcome the extra attention they get from their cancer care team. Studies have shown that people with cancer who felt well informed before they took part in a clinical trial had less regret after the study than those who felt unsure.

A placebo is a fake pill or treatment used in some types of clinical trials to help make sure results are from the new treatment or drug. Most cancer clinical trials do not use placebos unless they are given along with an active drug. There are some types of cancer that no treatments have proven to help. In rare cases, testing a new treatment against a placebo might be needed to prove that the treatment is better than nothing at all.

The very least you should expect from any clinical trial is to be offered the treatment standard of care. Not for studies that are randomized. This means that each person in the study gets assigned by chance to either the treatment group or the control group who get the best current treatment.

Randomization helps decrease the chance that the people in one group will be so different from the other that it could affect outcomes.

Randomization helps to make sure that the groups have people in similar states of health, so the results are not affected by differences between the groups. Only exceptions are patients with physical or mental disability.

More info. Print Share. Reasons to Participate. Medical research finds ways to help people live longer, improve their quality of life and manage or cure disease. This is possible because of the people who volunteer to participate in clinical trials. In addition to standard care and treatments, we perform studies to help find better ways of preventing, diagnosing and treating various types of cancer.

Benefits and drawbacks Participating in a clinical trial has risks and benefits. Benefits may include: Access to promising treatments not available elsewhere. Enhanced cancer care that incorporates the latest advances with your current standard of care. Close monitoring by a robust team of research doctors and nurses and other healthcare professionals.

Getting to take an active role in your care. Helping others contribute to medical research. Drawbacks may include: The treatment may not work for you or be less effective than your current standard of care. More ». Have you considered participating in a clinical trial?

Clinical trials are part of clinical research and at the heart of all medical advances.