Enrolling in a clinical trial is completely voluntary. If you take part in a clinical trial, you may be treated in a hospital, clinic, or doctor's office.

Clinical Trial Protocol

In order to provide reliable and generalized results, each clinical trial must follow strict scientific standards. To accomplish this, each clinical trial will have a formal written plan - called a protocol - that details what must be done and why.

Each center that does the study uses the same protocol. The protocol will be carried out by an experienced local physician, along with a dedicated clinical trial staff. Your primary care physician and any specialist that you see will also be kept informed of your decision to participate in a clinical trial.

Who Can Participate

There are so many different kinds of clinical trials available; almost anyone can consider participation in a clinical trial.

The clinical trial protocol will detail who can take part in the study. Criteria varies from trial to trial, but common factors that may be considered include: age, gender, the type and stage of disease you have, and whether you have already had certain treatments or other health problems.

Enrollment to qualifying individuals is limited so the new approach can be tested on similar groups of people. This helps define who the clinical trials' results will benefit. These criteria also act as a safety measure. They ensure the clinical trial excludes any people whom the protocol has known risks that outweigh any possible benefits.

Comparison Groups

In most clinical trials, researchers use comparison groups. This means that the patients taking part in a trial are assigned to one of two or more similar groups. Each group will receive different medical treatments. For example, one group may get the current standard treatment for a condition, while another group gets the standard treatment plus a new treatment. Researchers can then compare the results to see whether one group has better outcomes than the other.

Using comparison groups also ensures that no one in a study is left without treatment for the sake of research. Sometimes, when no accepted standard treatment exists for a condition, people in one group may receive a placebo. This is an inactive product that looks like the test product. You'll be told if a placebo will be used in a study before you agree to take part.

Randomization

Most clinical trials that have comparison groups use randomization. This involves assigning patients to different comparison groups by chance, rather than choice. Usually, a computer program makes the group assignments.

Blinding

Another method used to prevent bias in a clinical trial is to ‘blind’ a study. In a single blind study, the participant is not told if they are taking the standard treatment or the new treatment being tested. Only the doctor knows. In a double-blind study, neither the participant nor the doctor knows which treatment the participant is receiving. These studies are done, so that expectations about the experimental drug cannot influence the results of the study.