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I’m About to Start a Clinical Trial. Now What?

So you’ve enrolled in a clinical trial. Congratulations! You’ve just taken an important step toward contributing to better health outcomes for people all over the world. And for many of you, this may also mean that you are receiving research as care for yourself. This is a big, exciting step and we’re here to help you know what to expect. 

Understand Your Trial Phase

There are clinical trials for each phase of pharmaceutical or medical device research. Here is a quick breakdown of what the different phases mean to help you understand more about the trial phase you are participating in. 

Phase 0: These early exploratory clinical trials test less than 1% of the amount of the drug that will be used in later trial phases. This low-dose trial makes sure the medicine works as expected in the human body before conducting full-dose trials. 

Phase I: Trials in this phase are all about safety. This type of trial often seeks healthy volunteers. 

Phase II: Now we’re getting into treatment effectiveness trials. If you’re receiving research as a care option, you may be in a Phase II trial. 

Phase III: Once a treatment is proved effective, longer-term trials that last several years and involve many more trial volunteers like you take place. This is another trial phase where you may be receiving research as a care option. 

Post-market: Once new treatments are approved, ongoing studies may continue to observe the long-term effects of the drug. 

Medical device trials: If you are volunteering for a medical device trial, the safety trial phase is called a pilot study, also known as a feasibility study. The effectiveness trial phase is called a pivotal trial. Then once the device is approved, post-market studies continue just as they do for pharmaceuticals. 

Informed Consent

As a clinical trial volunteer, a research representative will walk you through what is called the “informed consent” process. This is where study staff explain the possible risks and benefits of the trial and everything that is involved in your participation. You will have the opportunity to have any questions answered and confirm that you want to participate after receiving all the information. You can also choose to have a patient advocate support you through this process. 

Trial Access

The sponsor of your trial will discuss the logistics of trial access with you. Some trials require on-site, in-person visits to participate in the study, while others have some on-site visits and some check-ins that can be conducted from your home or from your existing medical practitioner’s office (called “hybrid trials”). In fact, some clinical trials can be conducted completely remotely with data collected from your home or doctor’s office (called “decentralized or virtual trials”). Your study’s sponsor will explain all the details for your particular trial so you know exactly what to expect. 

If travel to the study site is required, your sponsor can answer questions about support with travel financing and logistics. 

What Happens When the Trial Is Over?

It can take years from the start of a clinical trial to when the study is completed and all data are reviewed and analyzed. Stay in touch with your sponsor contact about study results, realizing that the final results of any study may take quite a long time to be released. 

In the meantime, work with your sponsor, patient advocate, and/or your trusted medical team to continue your clinical trial journey. 

Want to learn even more about what it’s like to participate in a clinical trial? Be sure to check out our other blogs to discover firsthand stories from patients like you as well as more information about how and why to participate. 

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