Have you ever thought closely about the contents of your medicine cabinet? The medicines inside may have different purposes, but they have something in common: before reaching you, they underwent years of scientific studies to ensure they were safe for you to take. These studies are called clinical trials.
Clinical trials and research studies provide critical information about a drug’s safety and effectiveness, and generate data that can lead to the creation of other new treatments. Every potential drug undergoes multiple phases of research, each with a different goal. No new drugs can be approved without going through this process. Ultimately, clinical trials make a difference not just for today’s patients, but also potentially to those who’ll be diagnosed in the future.
Choosing to participate in a clinical trial is a personal and individual decision. Everyone is different. In a study by the Center for Information and Study on Clinical Research Participation (CISCRP), the following factors were common motivations for participants:
One of the responsibilities of medical professionals who run clinical trials is to care for participants who have volunteered. These professionals may go by unfamiliar titles like Principal Investigator or Study Coordinator, but they are, also, doctors, nurses, and trained research professionals. As such, these professionals monitor participant safety and well-being. Trial professionals will adjust study-related care when they feel it’s in the participant’s best interest. This may mean withdrawing a participant from a clinical trial. They will also often coordinate care delivery with the participant’s personal physician and healthcare team.
Everyone conducting a clinical trial has strict legal and ethical responsibilities related by law. To ensure these duties are followed and that participants are treated well, a team of people, who are independent from conducting the research, is asked to review and maintain oversight over each clinical trial. These teams of people are called Ethics Review Boards (or Institutional Review Boards or Independent Ethics Committees). An ERB reviews every clinical trial to ensure appropriate steps are taken to protect the rights and welfare of the people participating. The ERB must review the clinical trial before participants can enroll. ERB representatives are available to participants if they have any questions.
Each treatment tested in a clinical trial has different risks and benefits. And because all clinical trial participants are different, they will experience these risks and benefits in different ways. For example, one participant may experience a side effect that another participant does not.
Since clinical trials are experiments, the exact risks and benefits can be difficult to predict. But researchers only move forward with clinical trials when they are optimistic about the potential benefits and believe the risks for participants are acceptable. In addition, an Institutional Review Board (IRB) must review the research protocol, or plan, before researchers can enroll participants. Researchers inform participants about potential risks and benefits before they enroll in a clinical trial. This discussion takes place during what’s called the Informed Consent process, which helps participants understand what’s involved so that they can make the decision that’s right for them.
Factors that allow someone to participate in a clinical trial are called “Inclusion Criteria”.
Those that disqualify someone from participating are called “Exclusion Criteria”. These criteria are based on things such as age, the type and stage of a disease, previous treatment history, other medical conditions someone has and the medications they are taking.
Inclusion and Exclusion Criteria are developed with much thought and consideration. They are necessary to prove whether medicines work or not in a specific group of people and to make sure the right participants enter the trial and stay safe. These criteria are applied to all potential participants equally before they start the study.
Participants can drop out of a clinical trial even after they have agreed to participate. And they do not need to give a reason. No matter what stage of a clinical trial they are in, participants have the right to change their mind. If a participant decides to stop participating, the Principal Investigator will remove them from the trial in a way that is safe for the participant.
For most clinical trials, study medication is provided and visits are conducted at no cost to the participant. However, that’s not always the case and it is important to ask about any costs.
Some clinical trials pay 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 more substantial, while payment for a Phase 4 trial is often only reimbursement for time and travel.
Participants learn about any costs or payments before enrolling in a clinical trial, during the Informed Consent process.
Clinical trials can be conducted in a variety of places, including hospitals, universities, doctors’ offices, and community clinics all around the world. Some clinical trial facilities are fully dedicated to research, while other facilities house both research and healthcare delivery. Similarly, some medical professionals who conduct clinical trials devote all of their time to research, while other professionals split their time between research and healthcare delivery.
An estimated 2.2 million people participated in clinical trials in 2013. During that same year, a survey by the Center for Information and Study on Clinical Research Participation (CISCRP) found that 95% of clinical trial participants would consider enrolling in another clinical trial. And 91% thought the experience they had in their clinical trial was “Excellent” or “Good.”