Clinical Trial Information

Choosing to join a clinical trial is a personal and individual decision. According to the Center for Information and Study on Clinical Research Participation (CISCRP), common reasons for study volunteers to join a clinical trial include:

• to advance science and treatments
• to help others with the same condition or disease as them
• to potentially obtain better treatment

Visit this CISCRP infographic to see why people are willing to take part, or not take part, in clinical trials: Deciding to Participate

One of the responsibilities of the healthcare team who run clinical trials is to care for participants (People who take part in clinical trials, also called study volunteers.) . The people in this team may go by unfamiliar titles like Principal Investigator or Study Coordinator. But they are also doctors, nurses, and trained researchers. This means that they are trained to look after your safety and health. They may do this by talking with your personal healthcare team about your needs and treatment, or by talking to you about whether you want to continue in the trial.

Everyone conducting a clinical trial has strict regulatory and ethical duties. Teams of people, called an Ethics Review Board (ERB) or Institutional Review Board (IRB), operate independently from the day-to-day conduct of research. An ERB or IRB review every clinical trial before people can take part. This is to ensure that the correct steps are taken to protect participants' welfare and rights. An ERB or IRB protect participants by;

• making sure that clinical trial risks are as low as possible for participants
• ensuring the potential benefits of the clinical trial outweigh the risks
• making sure that a clinical trial meets overall safety requirements for participants

Each clinical trial has different risks and benefits. And as each clinical trial volunteer is different, they will experience these risks and benefits in different ways. For example, one person may experience a side effect from the study medicine but another person might not.

Clinical trials are experiments, so the exact risks and benefits can be difficult to predict. Researchers only move forward with clinical trials when they are optimistic about the potential benefits and believe any risks for participants are acceptable. In addition, an Ethics Review Board (ERB) or Institutional Review Board (IRB) must review the study plan before researchers can ask participants to join. Researchers discuss the potential risks and benefits of a clinical trial with participants before they might agree to take part. This talk takes place during the informed consent process. This process helps participants understand what is involved in the study so that they can make an informed decision on whether to join.

The set of criteria to enter a clinical trial is chosen very carefully. For each trial, this set of criteria is needed to prove whether a medicine works or not in a specific patient population. These requirements are applied equally to potential participants before they join the study. Trial criteria are based on things like age, gender, the type and stage of a disease, previous treatment history, and other medical conditions.

Participants can withdraw from a clinical trial at any time, for any reason. No matter the stage of the trial, participants have the right to change their mind. If a study volunteer decides to leave the study, the Principal Investigator will remove them from the trial in a safe manner.

For most clinical trials, the study medicine is provided and visits are conducted at no cost to the participant. However, this is not the case for all trials.

Some clinical trials pay or reimburse participants. These payments, if any, tend to vary based upon the phase of the trial. For example, payment for a Phase 1 trial is often greater, as in this phase, the medicine being studied is less understood. On the other hand, payment for a Phase 4 trial is often only reimbursement for time and travel.

Participants learn about any costs or payments before deciding to join a clinical trial during the informed consent process (Before joining, the study is explained to each participant and they are given the chance to ask any questions. The purpose of this process is to protect the rights of study participants and to make sure that they are properly informed of important study details.) .

Clinical trials can be conducted in many places including hospitals, universities, doctors' offices, and community clinics. Some activities for clinical trials may even take place in the participants' home.

In 2019, a survey by the Center for Information and Study on Clinical Research Participation (CISCRP) found that 96% of clinical trial participants would consider joining another clinical trial in the future. Also, 78% of respondents thought their experience in a clinical trial met or exceeded their expectations.