- Clinical Trial Basics
- Trial Participation
- Safety and Security
- Trial Terms Defined
What does it mean if I provide “informed consent”?
Your “informed consent” is required before you can join a clinical trial. This means you’ll receive all the important details about the study—how it’s designed, what your participation will involve, your right to leave at any time, available alternatives and any potential risks and benefits. Informed consent ensures you understand the trial fully and is in place to prioritize and protect your safety throughout the study.
What is the difference between a clinical trial and “standard of care”?
The “standard of care” refers to a treatment that has already been approved for a specific health condition and is widely available to the public. In contrast, interventions used in clinical trials are still being tested to confirm their safety and effectiveness before they can become part of standard medical practice.
What is the difference between interventional studies and observational studies?
Interventional studies test new treatments that have not been approved by regulators, while observational studies evaluate existing, approved treatments by monitoring participants’ health outcomes over time. In interventional studies, participants are often randomly assigned to different groups, receiving various treatments for comparison.
In observational studies, participants are not assigned a treatment, and they continue with the treatments already prescribed as part of their regular care. (On this site, most references to clinical trials refer primarily to interventional studies.)
What does “randomized” mean?
To ensure unbiased results and high-quality data, participants are randomly assigned to different groups. This means you could be placed in the group receiving the experimental treatment, the standard treatment, or a placebo. Random assignment helps ensure that any differences observed between groups are due to the treatment being studied, not pre-existing factors or bias.
What is a “placebo”?
A placebo is an inactive version of a treatment that does not provide any medical benefit. It is designed to look the same as the active intervention, so neither the participant nor the research team knows who is receiving the placebo. Placebos are used to compare outcomes and confirm whether the experimental treatment has a real effect, especially when no approved treatment is available for the condition being studied.
What does “blinded” mean?
Some clinical trials are designed to be “double-blind,” meaning neither the participants nor the researchers know which group a participant is assigned to. This approach helps prevent bias, so expectations or assumptions don’t influence the results.
What is a “control” or “control group”?
Researchers compare the effects of a new intervention by evaluating participants who receive the treatment against those who do not. This second group is known as the “control” or “control group.” Depending on the study, the control group may receive either a placebo or no treatment at all. These comparisons help researchers determine whether the new intervention is truly effective.
What is “expanded access”?
Patients facing an immediately life-threatening condition may be able to access an experimental treatment if no other effective options are available. This opportunity, often referred to as “compassionate use” or “expanded access,” provides a potential path to try promising interventions still under investigation.
What is a Plain Language Summary?
Plain language summaries are the outcome of the clinical trial journey for a participant.
We work with our industry peers to enhance how companies may share clinical trial information with our participants, consistent with applicable laws and regulations.
As part of our patient focused drug development approach here at AbbVie, we provide results summaries about completed trials in an easy and understandable manner while upholding our commitments to trade associations principles and the European Union (EU) Clinical Trials Regulation requirements.
A summary of clinical trial results for laypersons, referred to as a lay summary of results or plain language summary (PLS), is a brief description of the clinical trial results in everyday language that is understandable to people who do not have a medical or scientific background.
Sharing plain language summaries of completed clinical trials with study participants can give them valuable insights into the clinical trial journey and illustrate the valuable role they have provided. AbbVie has been disclosing PLS since 2019.
View Available Plain Language Summaries. Click Here