Clinical Trial Basics

Learn more about the role of clinical trials as a cancer treatment option, and why diverse patient participation in clinical trials is important.

On this page you will find answers to these questions:

• What is a clinical trial?
• How is the safety of clinical trial participants protected?
• Why is participation from communities of color important?
• Where can I find additional information on clinical trials?

What is a clinical trial?

A “clinical trial” is a type of health research that tests new drugs and procedures in human patients to prevent, detect, diagnose, or treat cancer and other diseases.

• Clinical trials are the safest and fastest way to find treatments that work for a wide variety of cancers and can ultimately, improve, extend or save lives.
• Clinical studies are conducted by a research team made up on doctors, nurses, social workers, research assistants, and other healthcare specialists.
• There are many reasons why people participate in clinical trials, but most frequently, it is because standard treatments have failed or they wish to contribute to the advancement of medical knowledge.

How is the safety of clinical trial participants protected?

Today, there are strict regulations and laws to ensure safety, fairness, and equitable treatment for all participants.

• Informed consent: a process by which a person voluntarily confirms his or her willingness to participate in a particular trial, after having been informed of all aspects of the trial that are relevant to the person’s decision to participate. Informed consent is documented by means of a written, signed and dated informed consent form (ICF).
• Continues through the entire study when there is new information or additional questions from patient.
• Patients are free to withdraw from the study at any time.
• Must ensure that withdrawal is done safely.
• Institutional Review Board (IRB): primary function is to ensure the safety of the patients participating in clinical trials.
• Determines whether the risks to the patients participating are reasonable with respect to the potential benefits.
• Reviews and approves (or disapproves) all components of trial.
• Monitors the ongoing progress throughout the research study.

Why is participation from communities of color in clinical trials important?

Through clinical trials, doctors learn as much as they can about which drugs, procedures, and other treatments work best for specific groups of people and which are successful in the whole population.

• Some treatments may not be equally effective for all groups of people and some groups may experience different side effects than others. For example, if a drug is only tested in males, researchers will not know if that drug will have the same results in females. Similarly, if a drug is only tested in one specific race or ethnicity, researchers will not know if that drug will have the same results in other races or ethnicities. The more patients that participate in clinical trials and the more diverse these patients are, the more that researchers and doctors will know about treating a wide range of people across race, gender, and age.
• Many communities of color are currently underrepresented in clinical trials, which makes it difficult for doctors to develop the most effective treatments for them.

Where can I find additional information on clinical trials?

Search open clinical trials at the Mass General Cancer Center for you or a loved one.

To learn more about clinical trials, please visit the following sites:

• National Cancer Institute
• ClinicalTrials.gov