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What Is a Clinical Trial?
A clinical trial is a research study that involves human participants to test the safety and effectiveness of potential new medical treatments, drugs, devices and tests. Before these treatments can be used by the public, they undergo careful testing in clinical trials to ensure their safety and effectiveness.
Participating in a clinical trial—whether you're addressing a health concern or volunteering as a healthy individual—contributes to advancing medical discoveries that may benefit future generations.
Types & Phases
Types of Clinical Trials
If you decide to participate in an AbbVie clinical trial, it will be one of two kinds: interventional or observational.
Interventional
Interventional trials are what most people think of when they hear “clinical trials.” These studies test potential new interventions – that is, drugs, medical devices, or procedures – to determine if they are safe and effective at modifying disease. Trial participants may receive the intervention being studied, a placebo or standard care. In some trials, like those to identify the adequate dose, everyone gets the intervention or treatment, and no one receives a placebo. When the trial concludes, researchers analyze the data and, if successful, may submit their findings to regulatory agencies like the FDA for approval.
Observational
In observational studies, researchers monitor people’s health during their normal routines or treatments without assigning specific interventions. These studies help researchers understand more about conditions, trends and patient behavior. Observational studies may be used, for instance, to learn how exercise affects heart health, or how well patients adhere to current treatment guidelines. They may be especially useful when there are ethical concerns about conducting interventional studies, like asking diabetes patients to stop insulin. Observational studies provide crucial insights before more controlled trials are conducted, or after a new intervention is approved for use.
Clinical Trial Phases
Clinical trials progress through four phases, each with a unique goal to ensure a treatment’s safety and effectiveness. At every phase, participants receive the latest information to make informed decisions about joining. Clinical Trial Phases - Learn More
Step 1
Phase I
Phase I trials are a critical first step in testing a new drug, procedure or medical device in humans. They assess the intervention’s safety and examine how the body tolerates and processes it. These studies often take place in a controlled setting such as the Abbvie Clinical Pharmacology Research Unit (ACPRU). For investigational drugs, these studies can include different dosages. About 63% of interventions successfully advance to Phase II. 1
Step 2
Phase II
Phase II studies focus on an intervention’s effectiveness while also collecting data about safety and side effects. About 31% of Phase II trials are successful enough to move to Phase III. ¹
Step 3
Phase III
Phase III trials are the last research stage before a treatment can be approved for public use. These studies compare the new intervention’s effectiveness and safety with existing treatments. About 58% of Phase III trials succeed and are submitted for regulatory approval, and about 90% of those are approved, though the approval process can take an additional 1.5 years. ¹
- Usually includes 300 – 3,000 participants.
- Participants have a specific condition.
- Takes about 3 years to complete.
Step 4
Phase IV
Even after a treatment is approved, research continues in Phase IV trials. These are typically observational studies in which researchers gather important data on safety, benefits, risks, and quality of life. The goal of Phase IV trials is to assess how the intervention performs in real-world settings.
- Usually includes several thousand participants with a specific condition.
- Helps determine the optimal way to deliver the treatment.
- Takes many years to complete.
Are Clinical Trials Safe?
It’s normal to feel hesitant about joining a clinical trial, but studies follow the highest safety and ethical standards. Participants are closely monitored to ensure both their well-being and the study’s success. Participation is always voluntary, and you can leave the trial at any time if you change your mind. That said, it’s important to carefully consider potential risks before enrolling:
- You cannot choose your treatment in a clinical trial. For drug trials, this means you may be assigned a specific dosage or a placebo, depending on the study design.
- The experimental treatment may not be more effective than existing treatments and could potentially cause more severe side effects.
- Taking part in a trial may require more doctor visits than usual.
- Trial treatments might not be fully covered by health insurance.
Who Should Participate in a Clinical Trial?
If you have a health condition, joining a clinical trial might give you access to investigational treatments. By participating, you’re contributing to the advancement of medical research which may benefit others with similar conditions in the future. Healthy volunteers are just as important in helping advance medical research and make progress possible.
Benefits of participation may include:
- Access to investigational drugs, devices or therapies.
- Access to a specialized team of healthcare professionals that can give you a deeper understanding of your condition.
- Access to the latest medical research and information on the condition.
- The fulfillment of contributing to future healthcare advancements.
Learn more about AbbVie's commitment to inclusion and representation. Before deciding to participate, it's important to consult your doctor to fully understand the risks and benefits.
Find Answers to Common Questions
If you still have questions, you can find more information on our FAQ page.
References
1 Muller, A. (2016) Parsing clinical success rates. Nature Reviews Drug Discovery, 15, 447. https://doi.org/10.1038/nrd.2016.136