A clinical trial is a research study that tests a medical treatment such as a drug, therapy, or procedure with the help of volunteers. Volunteers may be either healthy individuals or patients with medical conditions. These studies are conducted by doctors and clinical research staff to help understand if a drug is safe and works well for the people who need it, with the goal to improve people’s health and quality of life.
The study methods are designed to follow closely monitored protocols. These methods are reviewed and approved by regulatory agencies and ethics committees. Your participation may help you as well as future patients receive better care and treatment options.
Participating in a clinical trial might give you access to an investigational treatment, which can be especially important if current treatments do not work well for your medical condition. You also would play an active role in your own healthcare. Additionally, the study may help doctors learn more about cancer and help other people in the future. You should always discuss your potential participation with your doctor.
Clinical trials are essential for advancing medical knowledge and improving patient care. They help doctors find better ways to understand, prevent, diagnose, and treat medical conditions. Most medicines available today are the result of volunteers participating in clinical trials driven by patients needing additional treatment options. Although there is no guarantee of personal benefit, participation contributes valuable knowledge that may help future volunteers or patients.
No. Some clinical trials do provide options for people in whom standard care treatment did not work. However, many clinical trials test whether a drug may have fewer side effects or may be better in treating a disease or medical condition than a standard treatment. Also, some clinical trials are designed to test treatment in healthy volunteers (people without a disease or medical condition).
Clinical trials follow a specific plan called a protocol. This plan explains how the clinical trial will be conducted, who can participate, and how study participants will be monitored for safety. Additionally, clinical trials must follow strict guidelines set by regulatory agencies and ethics committees to ensure protection of participants and require a participant to sign an “Informed Consent” form. The informed consent process for clinical trials makes sure that study participants understand the study’s purpose, risks, and potential benefits before agreeing to participate. Study participants are carefully checked throughout a clinical trial. They have regular checkups to track their health and any responses to the treatment.
Study participants:
Potential risks include the following:
Clinical trials must follow strict guidelines set by regulatory agencies and ethics committees. They must be approved by an Institutional Review Board. These people review the study protocol to ensure it is ethical. Clinical trials must also follow international ethical guidelines like the Declaration of Helsinki and Good Clinical Practice guidelines, which are required to protect the safety of volunteers.
Taking part in a clinical trial is your choice. If you decide to take part in a clinical trial, you may stop at any time and for any reason without penalty. However, you should always inform your study doctor if you wish to leave the clinical trial.
Multiple organizations oversee clinical trials to ensure patient protection, ethical behavior, fairness, and honesty, including the following:
A randomized controlled clinical trial is a type of research study where participants are randomly put into different groups receiving different treatments. One group receives the experimental treatment (treatment group), while another group (the control group) receives either a standard treatment or in some cases a placebo (inactive treatment). This process helps to compare results fairly.
In some cases, studies may be:
Clinical trials are done in different phases, and each phase is a separate study usually involving different groups of volunteers.
In phases 1 to 3 of a clinical trial, the study treatment may be one that is not approved yet or is already used for another disease/condition but is now being tested in a new way or for a different disease/condition. Phase 4 studies, on the other hand, use treatments that are already approved specifically for the disease/condition being studied.
Clinical trials can take place in multiple locations, including university or community medical centers, clinics or hospitals, private research facilities, or doctors’ offices. Some clinical trials occur at a single location, while others are conducted at multiple sites across a country or around the world.
A clinical trial team (or study team) may include the following:
Clinical trials can be funded by various organizations, including the following:
You may be able to find clinical trials through the following:
Each clinical trial has specific requirements about who can participate. These rules are called eligibility criteria and are based on several factors including age, gender, type and stage of disease, previous treatment history, and other medical conditions. The study team determines whether a patient qualifies to participate in a clinical trial.
If you do not qualify for a particular study, there may be other studies that are right for you, or new studies may become available in the future. Talk with your doctor about other treatment options or other studies that might be suitable for you.
Many clinical trials work to include diverse study participants by:
After a clinical trial ends, the study team reviews the study results. Depending on the clinical trial, you might:
Results of a clinical trial may be presented at a scientific meeting, published in a scientific journal, and/or posted on websites such as clinicaltrials.gov. Results may also be made available to patients in easy-to-understand summaries that are posted online.
As a study participant, you have the right to:
The informed consent process for clinical trials makes sure that study participants understand the study’s purpose, risks, and potential benefits before agreeing to participate. The required information typically includes the following:
Your data (study results) are protected by privacy rules. This information is typically coded or made anonymous before being reviewed or shared. The consent form will explain how your data will be used, who will have access to it, and how long it will be kept. Most clinical trials must register their results in public databases, but individual study participants are never identified.
Results typically become available after the clinical trial is completed and all data have been analyzed. This can take months or years. Once analyzed, results are often published in medical journals and/or presented at scientific meetings. Many clinical trials also post results on company websites, ClinicalTrials.gov, or other public websites.
Yes, you can continue to see your usual doctors and inform them of your participation in the clinical trial. Your study team and regular doctors and specialists can work together to ensure that you receive complete care.
With your consent, medical information from the clinical trial may be shared with your regular doctors. This could include test results, treatments given, and any side effects experienced. This helps ensure that you receive complete care.
With your permission, the study team can share information with your family members. You control who gets information while participating in a clinical trial.
Often, the treatment being studied is free to study participants. However, there may be other costs related to the clinical trial, such as travel expenses or hospital stays. It is important to discuss potential costs with the study team before agreeing to participate as other related costs may vary depending on the clinical trial.
Many health insurance plans cover routine care costs related to clinical trials, but policies vary. In the United States, the Affordable Care Act requires most health insurance plans to cover routine costs in approved clinical trials. Before participating in a clinical trial, check with both your health insurance company and the study team to understand what costs will be covered.
Compensation varies widely between clinical trials. Some studies involving healthy volunteers may pay for:
Any payments usually only cover study-related costs rather than a reward for your participation. The informed consent document will outline any payments offered.
Time needed will vary depending on the clinical trial. Some clinical trials might require just a few visits over several months. Others might involve more frequent or longer visits. The study team will explain how much time is expected from you before you decide if you want to participate.
