Before joining an AstraZeneca clinical trial and during its conduct you’ll go through a series of steps to ensure you match the requirements which will help you to make a decision on joining the study.
The clinical trial team will schedule an appointment to provide more details about the clinical trial and to learn more about you to see whether you can join it.
If you are eligible to participate and decide to join the clinical trial, you will sign an Informed Consent Form (ICF). The ICF acknowledges that you understand what will happen during clinical trial conduct, and identifies your rights and responsibilities. This includes the expectation around clinical trial procedures and schedules, as well as the ability to leave the trial at any time.
Researchers will review your medical history and conduct a physical exam to make sure you meet all requirements for joining the clinical trial.
If you qualify, your participation can begin. Researchers will provide detailed instructions on the clinical trial procedures and on what you need to do and how often. Your health and safety are continually monitored during the entire duration of the clinical trial. Researchers may decide to stop your participation in the clinical trial if this is in your best interest. They can make such a decision as needed for your health, for example to protect you from excessive risk caused by side effects.
When you reach the end of the clinical trial, you’ll meet with your doctor to determine further care options. If you’re a healthy volunteer, your commitment is completed. Keep in mind that researchers can decide to end the clinical trial earlier than expected for different reasons.
Your participation in the clinical trial has ended. However, for AstraZeneca the work has not finished yet. After the clinical trial completion we:
Review data collected during the study conduct.
We will assess further steps and decide whether to move onto the next phase or whether to apply for market approval.
We will start to prepare clinical trial results for publication in either scientific journals or on public registries hosted by regulatory agencies such as Food and Drug Administration (FDA) or European Medicines Agency (EMA). We will also disclose clinical trial results on our AstraZeneca website and will create for you a summary of study results written in non-scientific and easy to understand language that will be published on the Trial Results Summaries portal (www.trialsummaries.com).
Family decisions about our loved ones and their healthcare can be extremely delicate. While the reasons and steps for enrolling your child in a clinical trial are similar to enrolling yourself, it’s understandable there may be a deeper level of anxiety.
Children may have different responses to treatments compared to adults, so studying all age groups can be extremely important. Clinical trials are also sometimes needed to fulfill pediatric regulatory requirements. After justifying the necessity for a study, clinical trials involving children require approval from ethics committees and health authorities. Extra protection methods are often added.
If your family is considering enrolling a child, researchers will outline all aspects of the clinical trial including the treatment, benefits and risks, necessary procedures and length of time. If you decide to participate, parents or caregivers (and the child, depending on age) must sign an Informed Consent Form.
Throughout the clinical trial, clinical trial members including doctors and nurses will always be accessible to monitor your child’s health. When the clinical trial ends, the team will work with your family to ensure appropriate ongoing care continues.
Clinical trials have different timelines due to the wide variety of investigational treatments and conditions. Before a person enrolls in a clinical trial, the clinical trial team will outline the specific amount of time you will be participating.
Depending on the condition, treatment duration, and requirements the clinical trial timelines could be only a few months or several years. In general, clinical trial participants do not pay additional out-of-pocket costs for participating in a clinical trial. However, this does depend on health care provision globally. Clinical trials do not always cover expenses like travel, housing, transportation, parking, or meals. You will learn more about these things during a pre-trial screening visit.
