A clinical trial is a research study that asks a very specific question. This may be about a given medical condition. Clinical trials may test new drugs or new treatments to see how well they work. They aim to find out if there are more effective options than those that currently exist. Clinical trials often compare standard care with a new treatment or close monitoring. They are meant to answer questions about safety and effectiveness. These include potential risks and benefits to patients. Clinical trials involve patients to try to answer these questions. They take place in clinics, hospitals, universities, or medical centers. The early phase of a clinical trial may take a couple of months. The later phases of a clinical trial may take many years.
Clinical trials look for better ways to prevent, diagnose, or treat medical conditions. They may also look at ways to improve quality of life for patients. Most major medical advances have resulted from a clinical trial. Clinical trials enable patients and clinicians to work together. This is often to answer an important medical question. This partnership also aims to find better answers to specific health questions. Patients often feel that taking part in a clinical trial is something positive. Their participation may provide future patients with more options in the future.
There are different types of clinical trials. There are four main steps called phases. If a treatment works well in one phase, it moves on to further testing in the next:
Sometimes, trial phases are combined, such as Phase I/II.
Some Phase II and all Phase III trials assign patients to different treatment groups. This is called randomization. This means a patient is assigned to a treatment group by chance rather than choice. Flipping a coin is an example of randomization. Instead of a coin flip, a computer determines which group the patient is assigned to. This ensures that results are due to difference in treatment. It also ensures that results are not due to other differences. This is a safe and scientific way to make a comparison. To take part in a clinical trial involving randomization, a person must agree to be randomized. They will not get to choose which group they wish to be in. They will have an equal chance of being assigned to either study group. If randomized to a group they do not wish to be in, they can leave the study.
There are many kinds of clinical trials. Each clinical trial studies certain groups of patients. Not everyone is eligible for a clinical trial. This can be due to medical conditions, overall health, or safety problems. Taking part in a clinical trial is a very important personal decision. Patients need to feel completely comfortable volunteering for trials. Potential risks and benefits should be discussed with your health care providers and your family members. If you would like to take part in a clinical trial, ask your doctor. You can also visit clinicaltrials.gov or breastcancertrials.org to learn more about which clinical trials are available for your condition.
There are advantages and disadvantages to taking part in a trial. Participants may have access to investigational drugs or devices before they are widely available to the public. Participants may take a more active role in their health care as a result of study participation. Contributing to research that may potentially benefit others in the future may also be an advantage. However, it is also important to consider disadvantages. These include the potential side-effects of new treatments. It is important to think about the time involved in taking part in a trial. Out-of-pocket costs (insurance, travel, parking) should also be considered.
Many protections exist to guard the rights of patients in clinical trials. During a clinical trial, patients will have their health monitored by the study team. Clinical trials have external groups that review patient experiences during the trial. This is done to ensure the rights and welfare of study participants are maintained. Patients, as well as health-care providers, may be included on these committees. Their job is to monitor the safety of patients in clinical trials.
Additional safeguards exist so patient rights are protected. For example, informed consent forms are checked to make sure they are signed properly. This review of risks and benefits is carried out before the trial begins. Participation in a clinical trial is voluntary. A person can withdraw from the trial at any time and for any reason. It is your right to discuss any questions about the trial with your doctor.
Select “WATCH A VIDEO” at the top of this page to listen to Dr. Shelley Hwang and a patient advocate discuss clinical trials.