Q&A

As with all medications there are risks of adverse reactions to the study medication.  Ethically approved clinical studies are designed to minimise the risks and ensure the safety of study participants. 

All clinical trials undergo a strict independent ethics committee review to ensure that a patient’s health and safety is paramount.

Clinical trials are designed to find new or better ways to prevent, detect, or treat health conditions. Often, researchers want to find out if a new treatment, or preventive measure is safe and effective. Treatments and preventive measures can include medications, surgeries, and medical devices.

People volunteer for clinical trials for many reasons. Some want to advance science or help doctors and researchers learn more about disease and improve health care. Others may join to try new or advanced treatments that aren’t widely available to them yet.

A healthy volunteer is someone in a clinical trial with no known related health problems. Normally only used in phase 1 studies, researchers need healthy volunteers to establish a healthy or optimal reference point. They use data from healthy volunteers to test new treatments or interventions, not to provide direct benefit to participants.

A patient volunteer is someone in a clinical trial who has the particular condition being studied. Researchers need patient volunteers to learn if new treatments are safe and effective. Not all trial participants will receive experimental medications or treatments; sometimes, participants may receive a placebo. Researchers need to vary medications and treatments so they can compare results and learn from their differences.

While a study’s treatment or findings may help patients directly, sometimes participants will receive no direct benefit. However, in many cases, study results can still serve as building blocks that are used to help people later.

Clinical trials can provide many benefits to participants and society. However, before volunteering for a clinical trial, you should talk with your health care provider and the study team about the risks and benefits.

When weighing the risks of volunteering, you should consider:

• The likelihood of any harm occurring
• How much harm could result from your participation in the study.
  
  

Researchers try to limit patient discomfort during clinical trials. However, in some cases, volunteers have had mild or severe complications that require medical attention as a result of treatment.

The benefits of volunteering can include:

• Treatment with study medications that may not be available elsewhere
• Care from health care professionals who are familiar with the most advanced treatments available
• The opportunity to learn more about an illness and how to manage it
• Playing an active role in your health care
• Helping others by contributing to medical research
• Care and treatment is free of charge

People of all ages, ethnicities, and racial backgrounds can volunteer for clinical trials. If you want to join a clinical trial, you must meet eligibility critera to participate in that specific trial. Your eligibility can usually be determined by phone or online screening.

All clinical trials have eligibility guidelines called inclusion and exclusion criteria. These criteria may include:

• Age
• Sex
• The type and stage of an illness
• Treatment history
• Other medical conditions

Researchers use these guidelines to find suitable study participants, maximize participant safety, and ensure trial data are accurate.

It can be helpful to write down any questions or concerns you have. When you speak with the study team, you may want to take notes or ask to record the conversation. Bringing a supportive friend or family member may also be helpful.

The following topics may give you some ideas for questions to ask:

• The study’s purpose and duration
• The possible risks and benefits
• Your participation and care
• Personal and financial concerns

Strict rules and laws help protect participants in research studies, and the study team must follow these rules to conduct research. Below are some measures that can help ensure your safety.  

Ethics committee approval needs to be sourced before the study can recruit participants.

An Ethics Review Board works to protect the rights, welfare, and privacy of human subjects. It usually includes a team of independent doctors, scientists, and community members. Their job is to review potential studies, weigh the risks and benefits of studies, and ensure that studies are safe and ethical.

Ethical guidelines protect volunteers and ensure a study’s scientific integrity. Regulators created these guidelines primarily in response to past research errors and misconduct.

Before joining a trial, you should understand what your participation will involve. The study team will provide an informed consent document with detailed information about the study. The document will include details about the length of the trial, required visits, medications, and medical procedures. It will also explain the expected outcomes, potential benefits, possible risks, and other trial details. The study team will review the informed consent document with you and answer any questions you have. You can decide then or later if you want to take part in the trial.

If you choose to join the trial, you will be asked to sign the informed consent document. This document is not a contract; it verifies you understand the study and describes what your participation will include and how your data will be used. Your consent in a clinical trial is ongoing and your participation is voluntary. You may stop participating at any time.

When a clinical trial ends, researchers will analyse the data to help them determine the results. After reviewing the findings, researchers often submit them to scientific journals for others to review and build on.

Before your participation ends, the study team should tell you if and how you’ll receive the results. If this process is unclear, be sure to ask about it.