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About Clinical Trials

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What is a clinical trial?

A clinical trial is a type of research study designed to learn if an investigational drug, device or procedure is safe, how it works in the body, and if it works to treat a specific disease. “Investigational” means that regulatory authorities, such as the FDA in the US or the EMA in Europe, have not yet approved it for use for a particular condition, disease, or patient population.

Without clinical trials, there would be no new medications.

Before a drug is made available to the general public, it must go through several phases of clinical research and regulatory approvals that show that it is safe and effective in treating a specific disease within the patient population that participated in the clinical trial. Most available medications are the result of past clinical research driven by patients’ unmet needs and lack of adequate treatment options. Without clinical trials and volunteer study participants, there would be no new medications.

Why diversity matters in clinical research

Once approved, drugs are prescribed for people of all different ages, genders, races, and ethnicities. Unfortunately, minority groups are underrepresented in clinical trials. This is a problem because drugs can work differently in different people, depending on some of these individual characteristics. Increasing diversity in clinical research will lead to better research, treatments and health outcomes for all people.

Phases of Clinical Research

The phases of clinical research

Clinical trials for investigational drugs are done in steps or "phases." Each clinical phase has a different purpose and helps the study researchers answer specific questions about the drug being tested. These phases are designed to minimize risk to study participants and also advance clinical research. If an investigational drug fails during any clinical phase, it does not move into the next phase of research.

PRE-CLINICAL TRIALS

Pre-clinical trials are conducted in a laboratory and evaluate safety and potential effectiveness. From there, the investigational drug may move into clinical trials in humans.

PHASE I

Phase I trials evaluate the potential safety profile and possible/likely side effects of an investigational drug in a small group of people.

PHASE II

Phase II trials further identify side effects and risks associated with the investigational drug and help to determine which dose of the drug works best. Phase II trials are usually conducted with a larger group of people than Phase I trials.

PHASE III

Phase III trials further evaluate an investigational drug’s safety, effectiveness, and side effects in an even larger group of people. Phase III trials help to confirm the findings of earlier research and may compare the investigational drug to existing approved treatments or to no treatment, possibly using a placebo. A placebo looks like the investigational drug but does not have the active ingredient.

PHASE IV

Phase IV trials refers to ongoing testing of a drug that occurs after that drug has been approved and made available to the general public, most often to evaluate its long-term effectiveness.

PRE-CLINICAL TRIALS

Pre-clinical trials are conducted in a laboratory and evaluate safety and potential effectiveness. From there, the investigational drug may move into clinical trials in humans.

Who is involved?

The Sponsor

The group who initiates, manages and funds the clinical trial. This may be a biotechnology or pharmaceutical company, academic medical centers, or other organizations, including government agencies.

The Participant

The person taking part in the clinical trial. Before joining any clinical trial, all participants (along with their parent, guardian, or caregiver if needed) must go through the informed consent process, during which they will have in-depth conversations with the Investigator to learn more about the trial, the risks and potential benefits, and the research procedures.

The Caregiver

Often a parent, spouse, or adult child; a caregiver is a person who supports another person taking part in a clinical trial if they need help managing some of their health care needs.

The Site

The medical institution(s) where the trial takes place. This can include a variety of locations, such as hospitals, doctors’ offices, or community clinics.

The Investigator

A researcher (usually a medical doctor) who is responsible for managing the clinical trial activities and overseeing study participants’ study-related care at a medical institution. An Investigator is part of the study team, which includes qualified doctors and other healthcare professionals who provide study-related care and closely monitor the health of each study participant.

The Participant

The person taking part in the clinical trial. Before joining any clinical trial, all participants (along with their parent, guardian, or caregiver if needed) must go through the informed consent process, during which they will have in-depth conversations with the Investigator to learn more about the trial, the risks and potential benefits, and the research procedures.

The Caregiver

Often a parent, spouse, or adult child; a caregiver is a person who supports another person taking part in a clinical trial if they need help managing some of their health care needs.

The Site

The medical institution(s) where the trial takes place. This can include a variety of locations, such as hospitals, doctors’ offices, or community clinics.

The Investigator

A researcher (usually a medical doctor) who is responsible for managing the clinical trial activities and overseeing study participants’ study-related care at a medical institution. An Investigator is part of the study team, which includes qualified doctors and other healthcare professionals who provide study-related care and closely monitor the health of each study participant.

The Study Coordinator

The study coordinator is a researcher who supports the management and coordination of clinical trials. The study coordinator is a part of the study team, which includes qualified doctors and other healthcare professionals who provide study-related care and closely monitor the health of each study participant.

The IRB or EC

An IRB, or Institutional Review Board, is a committee of independent doctors, nurses, and members of the community who help review and monitor clinical research to ensure the welfare, privacy, and rights of study participants are protected. Outside of the United States, this committee is known as an Ethics Committee (EC).

The Sponsor

The group who initiates, manages and funds the clinical trial. This may be a biotechnology or pharmaceutical company, academic medical centers, or other organizations, including government agencies.

What else is there to know?

Why do people choose to take part in clinical trials?

People choose to participate in clinical trials for many different reasons, including:
  • Helping others through advancing knowledge about a certain disease and potential treatment option
  • Potential access to investigational treatment or drug
  • Additional clinical trial related care, monitoring and tests from study doctors and nurses
It is important to note that participants may or may not directly benefit from participating in a clinical trial.

What are some of the risks in taking part in a clinical trial?

Risks vary depending on the trial. Known and possible risks will be fully explained by the study doctor, including new information about risks that becomes available over the course of the clinical research study. Further detail is included in the informed consent form. Since the investigational drug is still being studied, the researchers might not know about all risks. If the researchers learn about new risks during the trial, they will inform the trial physician, who will inform the participant.

What should a person consider before taking part in a clinical trial?

Potential participants should learn as much as they can about the trial, ask the members of the study team any questions they may have, and discuss the trial with their physician. For example, one might ask: “What is being tested in this trial?” “Who can participate in this trial?” "What are the potential risks to my health?" or “How long will this trial last?”

Other details to consider include the number of appointments involved, time/travel commitment for each appointment and the types of testing required.

What is informed consent?

“Informed consent” is a process to help patients decide whether or not to participate in a clinical trial. The informed consent document provides key information about a trial, such as the purpose of the research, its potential risks and benefits, how study data will be used, what is required of participants, and the rights of participants.

Before joining any clinical trial, potential participants (or parents/caregivers for children under 18) are required to sign an informed consent form to acknowledge that they were provided information about the study and possible risks of participation and that they agreed to participate in the research.

Participants can choose to leave the trial at any time and for any reason, even after signing the informed consent form.

What rights do participants have in a clinical trial?

It is always the choice of the potential participant whether or not to be in a clinical trial. Potential participants must also be given enough time to make that decision without any pressure from the study team. Even after they join, participants have the right to withdraw from the trial at any time and for any reason without any effect on their routine medical care.

Participants have the right to be told why the clinical trial is being done, what will be required of them as study participants, as well as any possible or known risks, discomforts, or side effects that may occur during the study. They will also be informed of the steps the study team will take to protect their personal health information, and to ensure that personal data collected during the clinical trial will be used only for the purposes explained to the participant prior to agreeing to participate in the trial.

More questions? Ask our virtual clinical trial guide.

Launch

Still have questions?

To learn more about clinical trials and whether participation might be right for you or someone close to you, please speak with your doctor.